Trial Outcomes & Findings for A Safety and Efficacy Study of 2 Dosing Regimens of Recombinant Human Nerve Growth Factor (rhNGF) Eye Drop Solution Compared With Vehicle in Patients With Dry Eye Disease. (NCT NCT06244316)

Last Updated: 2026-02-13

Results Overview

SANDE questionnaire included 2 VAS-based questions that assessed: (i) DED symptom frequency (from 0 to 100) (ii) DED symptom severity (from 0 to 100) compiled by the participants. The global SANDE score (from 0 to 100, with 100 representing the most frequent and severe dry eye symptoms) was calculated by multiplying the frequency score by the severity score and obtaining the square root. For SANDE global Score, the lower the score, the better the outcome. Adjusted means are reported. Data here reported are the data after having applied the predefined strategy to handle intercurrent events (i.e. data for SANDE collected in the week after an administration of a prohibited medication are set to missing under the hypothetical strategy while a treatment policy strategy is used for any other intercurrent event). Missing data for SANDE Global Score are imputed employing Multiple Imputation (MI) based on copy-reference approach assuming MNAR.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

317 participants

Primary outcome timeframe

Week 8 (V5)

Results posted on

2026-02-13

Participant Flow

317 participants (73.4%) were randomly assigned to receive the investigational product (106, 106, and 105 participants in the rhNGF 5 μg/mL, rhNGF 10 μg/mL, and vehicle groups, respectively). Of 317 participants randomized, 316 (99.7%) received at least 1 dose of IMP and were included in the FAS and SAF; 212 (66.9%) were included in the PP set. 1 participant of the vehicle arm was excluded from the FAS, SAF, and PP sets. This patient was randomized due to staff error but didn't receive any IMP.

A total of 432 participants were screened.

Participant milestones

Participant milestones
Measure	rhNGF 5 μg/mL IMP1: rhNGF 5 μg/mL - 1 drop of rhNGF ophthalmic solution at 5 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.	rhNGF 10 μg/mL IMP2: rhNGF 10 μg/mL - 1 drop of rhNGF ophthalmic solution at 10 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.	Vehicle Vehicle (Placebo solution): Eye drop solution, containing no rhNGF. 1 drop of vehicle in each eye TID at approximately 6-hour intervals, for 4 weeks of treatment.
Overall Study STARTED	106	106	105
Overall Study FAS	106	106	104
Overall Study SAF	106	106	104
Overall Study PP	69	71	72
Overall Study COMPLETED	102	99	103
Overall Study NOT COMPLETED	4	7	2

Reasons for withdrawal

Reasons for withdrawal
Measure	rhNGF 5 μg/mL IMP1: rhNGF 5 μg/mL - 1 drop of rhNGF ophthalmic solution at 5 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.	rhNGF 10 μg/mL IMP2: rhNGF 10 μg/mL - 1 drop of rhNGF ophthalmic solution at 10 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.	Vehicle Vehicle (Placebo solution): Eye drop solution, containing no rhNGF. 1 drop of vehicle in each eye TID at approximately 6-hour intervals, for 4 weeks of treatment.
Overall Study Adverse Event	0	3	1
Overall Study Lost to Follow-up	1	0	0
Overall Study Protocol Violation	0	0	1
Overall Study Withdrawal by Subject	3	4	0

Baseline Characteristics

A Safety and Efficacy Study of 2 Dosing Regimens of Recombinant Human Nerve Growth Factor (rhNGF) Eye Drop Solution Compared With Vehicle in Patients With Dry Eye Disease.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	rhNGF 5 μg/mL n=106 Participants IMP1: rhNGF 5 μg/mL - 1 drop of rhNGF ophthalmic solution at 5 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.	rhNGF 10 μg/mL n=106 Participants IMP2: rhNGF 10 μg/mL - 1 drop of rhNGF ophthalmic solution at 10 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.	Vehicle n=104 Participants Vehicle (Placebo solution): Eye drop solution, containing no rhNGF. 1 drop of vehicle in each eye TID at approximately 6-hour intervals, for 4 weeks of treatment.	Total n=316 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=41 Participants	0 Participants n=1581 Participants	0 Participants n=4626 Participants	0 Participants n=72 Participants
Age, Categorical Between 18 and 65 years	68 Participants n=41 Participants	61 Participants n=1581 Participants	63 Participants n=4626 Participants	192 Participants n=72 Participants
Age, Categorical >=65 years	38 Participants n=41 Participants	45 Participants n=1581 Participants	41 Participants n=4626 Participants	124 Participants n=72 Participants
Age, Continuous	59.1 years STANDARD_DEVIATION 12.43 • n=41 Participants	61.9 years STANDARD_DEVIATION 11.41 • n=1581 Participants	60.1 years STANDARD_DEVIATION 13.02 • n=4626 Participants	60.3 years STANDARD_DEVIATION 12.32 • n=72 Participants
Sex: Female, Male Female	86 Participants n=41 Participants	85 Participants n=1581 Participants	85 Participants n=4626 Participants	256 Participants n=72 Participants
Sex: Female, Male Male	20 Participants n=41 Participants	21 Participants n=1581 Participants	19 Participants n=4626 Participants	60 Participants n=72 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=41 Participants	1 Participants n=1581 Participants	1 Participants n=4626 Participants	2 Participants n=72 Participants
Race (NIH/OMB) Asian	7 Participants n=41 Participants	9 Participants n=1581 Participants	3 Participants n=4626 Participants	19 Participants n=72 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=41 Participants	0 Participants n=1581 Participants	1 Participants n=4626 Participants	1 Participants n=72 Participants
Race (NIH/OMB) Black or African American	33 Participants n=41 Participants	25 Participants n=1581 Participants	25 Participants n=4626 Participants	83 Participants n=72 Participants
Race (NIH/OMB) White	66 Participants n=41 Participants	69 Participants n=1581 Participants	73 Participants n=4626 Participants	208 Participants n=72 Participants
Race (NIH/OMB) More than one race	0 Participants n=41 Participants	0 Participants n=1581 Participants	0 Participants n=4626 Participants	0 Participants n=72 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=41 Participants	2 Participants n=1581 Participants	1 Participants n=4626 Participants	3 Participants n=72 Participants
Region of Enrollment United States	91 participants n=41 Participants	91 participants n=1581 Participants	90 participants n=4626 Participants	272 participants n=72 Participants
Region of Enrollment Italy	15 participants n=41 Participants	15 participants n=1581 Participants	14 participants n=4626 Participants	44 participants n=72 Participants
Study Eye Right Eye	55 Participants n=41 Participants	62 Participants n=1581 Participants	53 Participants n=4626 Participants	170 Participants n=72 Participants
Study Eye Left eye	51 Participants n=41 Participants	44 Participants n=1581 Participants	51 Participants n=4626 Participants	146 Participants n=72 Participants

PRIMARY outcome

Timeframe: Week 8 (V5)

Population: The Full Analysis Set (FAS) consisted of all participants in the randomized population (RND) who took at least one dose of IMP. The FAS was analyzed according to the intention-to-treat principle, i.e. by treatment allocation. Primary and secondary efficacy analyses were conducted on the FAS.

Outcome measures

Outcome measures
Measure	Vehicle n=104 Participants Vehicle (Placebo solution): Eye drop solution, containing no rhNGF. 1 drop of vehicle in each eye TID at approximately 6-hour intervals, for 4 weeks of treatment.	rhNGF 5 μg/mL n=106 Participants IMP1: rhNGF 5 μg/mL - 1 drop of rhNGF ophthalmic solution at 5 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.	rhNGF 10 μg/mL n=106 Participants IMP2: rhNGF 10 μg/mL - 1 drop of rhNGF ophthalmic solution at 10 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.
Mean Change From Baseline to Week 8 in Symptoms of Dry Eye Assessed by Symptom Assessment in Dry Eye (SANDE) Global Score	-15.5 score on a scale Standard Error 1.99	-19.6 score on a scale Standard Error 2.02	-20.7 score on a scale Standard Error 2.02

SECONDARY outcome

Timeframe: Week 4 (V4)

Population: The FAS consisted of all participants in the RND analysis set who took at least 1 dose of investigational product. The FAS was analyzed according to the intention-to-treat principle, ie, by treatment allocation. Primary and secondary efficacy analyses were conducted on the FAS.

Schirmer-I test was performed without anesthesia to determine wetting of the strip within 5 minutes, the length of the moistened strip being measured in millimeters (mm). "Improvement" is defined as having a change from baseline at the corresponding visit \>= 10 mm/5min in Schirmer-I test without anesthesia. Data analyzed and here reported were the data after having applied the predefined strategy to handle intercurrent events (ie, data for Schirmer-I Test collected in the week after an administration of a prohibited medication were set to missing under the hypothetical strategy while a treatment policy strategy was used for any other intercurrent event). Missing data for Schirmer-I Test were imputed employing an MI based on copy-reference approach assuming MNAR.

Outcome measures

Outcome measures
Measure	Vehicle n=104 Participants Vehicle (Placebo solution): Eye drop solution, containing no rhNGF. 1 drop of vehicle in each eye TID at approximately 6-hour intervals, for 4 weeks of treatment.	rhNGF 5 μg/mL n=106 Participants IMP1: rhNGF 5 μg/mL - 1 drop of rhNGF ophthalmic solution at 5 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.	rhNGF 10 μg/mL n=106 Participants IMP2: rhNGF 10 μg/mL - 1 drop of rhNGF ophthalmic solution at 10 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.
Key Secondary Outcome: Percentage of Participants Improving to Schirmer-I Test Without Anesthesia ≥ 10 mm/5 Min in the Study Eye at Week 4	12.1 percentage of participants Standard Error 3.25	11.7 percentage of participants Standard Error 3.23	7.3 percentage of participants Standard Error 2.65

SECONDARY outcome

Timeframe: Week 4 (V4)

The Schirmer test was used in ophthalmic examination to measure tear production for the diagnosis of several ocular conditions such as dry eye. Without previously instilling anesthetic drops, the Schirmer strip was inserted into the lower conjunctival sac at the junction of the lateral and middle thirds, avoiding touching the cornea, and the length of wetting strips in millimeters was recorded after 5 minutes. After 5 minutes had elapsed, the Schirmer test strip was removed and the length of the tear absorption on the strip was measured (millimeters/5 minutes). Cutoff values: \<5 mm - pathologic dry eye 5-10 mm - marginal dry eye \>10 and \<30 mm - normal secretion The longer the moistened strip, the healthier the status of the eye. Adjusted means are reported. Data here reported are the data after having applied the predefined strategy to handle intercurrent events. Missing data for Schirmer-I Test were imputed employing an MI based on copy reference approach assuming MNAR.

Outcome measures

Outcome measures
Measure	Vehicle n=104 Participants Vehicle (Placebo solution): Eye drop solution, containing no rhNGF. 1 drop of vehicle in each eye TID at approximately 6-hour intervals, for 4 weeks of treatment.	rhNGF 5 μg/mL n=106 Participants IMP1: rhNGF 5 μg/mL - 1 drop of rhNGF ophthalmic solution at 5 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.	rhNGF 10 μg/mL n=106 Participants IMP2: rhNGF 10 μg/mL - 1 drop of rhNGF ophthalmic solution at 10 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.
Key Secondary Outcome: Mean Change From Baseline to Week 4 in Schirmer-I Score Without Anesthesia in the Study Eye	2.9 mm Standard Error 0.62	3.5 mm Standard Error 0.63	2.9 mm Standard Error 0.62

SECONDARY outcome

Timeframe: Week 4 (V4)

Corneal fluorescein staining examination was performed at the slit-lamp using blue light. Corneal fluorescein staining was graded according to the NEI scale (5 zones, each zone scoring 0-3, with a total score ranging 0-15, with a higher number representing more staining). The five cornea zones are: central, superior, inferior, nasal and temporal. To avoid the phenomenon of quenching, which is increased in participants with dry eye, staining was assessed after 2-5 minutes from fluorescein instillation for fTBUT evaluation. Adjusted means are reported. Data here reported are the data after having applied the predefined strategy to handle intercurrent events. Missing data for The corneal fluorescein staining (NEI score) were imputed employing an MI based on copy reference approach assuming MNAR.

Outcome measures

Outcome measures
Measure	Vehicle n=104 Participants Vehicle (Placebo solution): Eye drop solution, containing no rhNGF. 1 drop of vehicle in each eye TID at approximately 6-hour intervals, for 4 weeks of treatment.	rhNGF 5 μg/mL n=106 Participants IMP1: rhNGF 5 μg/mL - 1 drop of rhNGF ophthalmic solution at 5 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.	rhNGF 10 μg/mL n=106 Participants IMP2: rhNGF 10 μg/mL - 1 drop of rhNGF ophthalmic solution at 10 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.
Key Secondary Outcome: Mean Change From Baseline to Week 4 in Total Corneal Fluorescein Staining (National Eye Institute NEI Scale) in the Study Eye as Assessed by the Investigator	-0.7 score on a scale Standard Error 0.23	-1.1 score on a scale Standard Error 0.23	-1.0 score on a scale Standard Error 0.23

SECONDARY outcome

Timeframe: Week 8 (V5)

Schirmer-I test was performed without anesthesia to determine wetting of the strip within 5 minutes, the length of the moistened strip being measured in millimeters (mm). The longer the moistened strip, the better the outcome. The ones reported are adjusted means. Missing data for Schirmer-I Test were imputed employing an MI based on copy reference approach assuming MNAR.

Outcome measures

Outcome measures
Measure	Vehicle n=104 Participants Vehicle (Placebo solution): Eye drop solution, containing no rhNGF. 1 drop of vehicle in each eye TID at approximately 6-hour intervals, for 4 weeks of treatment.	rhNGF 5 μg/mL n=106 Participants IMP1: rhNGF 5 μg/mL - 1 drop of rhNGF ophthalmic solution at 5 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.	rhNGF 10 μg/mL n=106 Participants IMP2: rhNGF 10 μg/mL - 1 drop of rhNGF ophthalmic solution at 10 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.
Mean Change From Baseline to Week 8 in Schirmer-I Score Without Anesthesia in the Study Eye	3.0 mm Standard Error 0.53	2.5 mm Standard Error 0.54	1.7 mm Standard Error 0.55

SECONDARY outcome

Timeframe: Week 8 (V5)

Schirmer-I test was performed without anesthesia to determine wetting of the strip within 5 minutes, the length of the moistened strip being measured in millimeters (mm). "Improvement" is defined as having a change from baseline at the corresponding visit \>= 10 mm/5min in Schirmer-I test without anesthesia. Missing data for Schirmer-I Score were imputed employing an MI based on copy-reference approach assuming MNAR. Samely, "Adjusted proportions" are reported, expressed under the term "mean" (the system doesn't provide the option "adjusted proportion").

Outcome measures

Outcome measures
Measure	Vehicle n=104 Participants Vehicle (Placebo solution): Eye drop solution, containing no rhNGF. 1 drop of vehicle in each eye TID at approximately 6-hour intervals, for 4 weeks of treatment.	rhNGF 5 μg/mL n=106 Participants IMP1: rhNGF 5 μg/mL - 1 drop of rhNGF ophthalmic solution at 5 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.	rhNGF 10 μg/mL n=106 Participants IMP2: rhNGF 10 μg/mL - 1 drop of rhNGF ophthalmic solution at 10 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.
Percentage of Participants Improving to Schirmer-I Test Without Anesthesia ≥ 10 mm/5min in the Study Eye at Week 8	10.6 percentage of participants Standard Error 3.04	8.1 percentage of participants Standard Error 2.74	6.4 percentage of participants Standard Error 2.49

SECONDARY outcome

Timeframe: Week 4 (V4) and Week 8 (V5)

fTBUT was measured by determining the time to tear film break-up. fTBUT was measured after instilling one drop of fluorescein into the inferior conjunctival cul-de-sac of the study eye. After the participant blinked several times, the examiner waited \~30 seconds. Using a slit lamp (10X, cobalt blue), the examiner recorded the fTBUT as the time from the last blink to the first break in the tear film. The shorter the time, the worse the outcome. The fTBUT was measured twice during the first minute after the instillation. If the 2 readings differed by more than 2 seconds, then a third was taken. The fTBUT value was the average of the 2 or 3 measurements. Missing data for fluorescein tear break-up Time were imputed employing an MI based on copy-reference approach assuming MNAR. Two separate imputation models were used for each timepoint. Adjusted means are reported.

Outcome measures

Outcome measures
Measure	Vehicle n=104 Participants Vehicle (Placebo solution): Eye drop solution, containing no rhNGF. 1 drop of vehicle in each eye TID at approximately 6-hour intervals, for 4 weeks of treatment.	rhNGF 5 μg/mL n=106 Participants IMP1: rhNGF 5 μg/mL - 1 drop of rhNGF ophthalmic solution at 5 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.	rhNGF 10 μg/mL n=106 Participants IMP2: rhNGF 10 μg/mL - 1 drop of rhNGF ophthalmic solution at 10 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.
Mean Change From Baseline to Weeks 4 and 8 in Fluorescein Tear Break-up Time (fTBUT) in Study Eye Week 8	0.4 seconds Standard Error 0.21	0.1 seconds Standard Error 0.21	0.2 seconds Standard Error 0.21
Mean Change From Baseline to Weeks 4 and 8 in Fluorescein Tear Break-up Time (fTBUT) in Study Eye Week 4	0.4 seconds Standard Error 0.20	0.3 seconds Standard Error 0.20	0.1 seconds Standard Error 0.20

SECONDARY outcome

Timeframe: Week 4 (V4) and week 8 (V5)

OPAS is a validated questionnaire. Administered to all patients, it was completed only by those that either had eye pain or had filled this form before. It has 7 domains: * eye pain intensity over 24 hours and past two weeks * non-eye pain intensity * quality of life * aggravating factors * associated factors * symptomatic relief Each subscale score= sum of scores divided by number of questions answered within each subscale. % values were divided by 10 before applying the algorithm. Ocular Pain Score = sum of the scores for eye pain intensity at 24 hours and 2 weeks (questions 4-9) divided by the number of questions answered for questions 4-9. This subscore ranges 0-10, where the higher the score, the worse the outcome. QoL score = sum of the scores for QoL subscale (questions 13-19) divided by the number of questions answered for questions 13-19. QoL scores range 0-10 where the higher the score, the better the outcome. MI was applied. Adjusted means are reported.

Outcome measures

Outcome measures
Measure	Vehicle n=104 Participants Vehicle (Placebo solution): Eye drop solution, containing no rhNGF. 1 drop of vehicle in each eye TID at approximately 6-hour intervals, for 4 weeks of treatment.	rhNGF 5 μg/mL n=106 Participants IMP1: rhNGF 5 μg/mL - 1 drop of rhNGF ophthalmic solution at 5 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.	rhNGF 10 μg/mL n=106 Participants IMP2: rhNGF 10 μg/mL - 1 drop of rhNGF ophthalmic solution at 10 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.
Mean Change From Baseline to Weeks 4 and 8 in the Ocular Pain Assessment Survey (OPAS) Questionnaire's Ocular Pain and Quality of Life (QoL) Scores Quality of Life - Week 4	-1.3 score on a scale Standard Error 1.23	-1.2 score on a scale Standard Error 1.22	-1.4 score on a scale Standard Error 1.19
Mean Change From Baseline to Weeks 4 and 8 in the Ocular Pain Assessment Survey (OPAS) Questionnaire's Ocular Pain and Quality of Life (QoL) Scores Quality of Life - Week 8	-1.9 score on a scale Standard Error 1.27	-1.9 score on a scale Standard Error 1.29	-2.0 score on a scale Standard Error 1.20
Mean Change From Baseline to Weeks 4 and 8 in the Ocular Pain Assessment Survey (OPAS) Questionnaire's Ocular Pain and Quality of Life (QoL) Scores Ocular Pain score - Week 4	-1.7 score on a scale Standard Error 1.22	-1.6 score on a scale Standard Error 1.18	-1.7 score on a scale Standard Error 1.19
Mean Change From Baseline to Weeks 4 and 8 in the Ocular Pain Assessment Survey (OPAS) Questionnaire's Ocular Pain and Quality of Life (QoL) Scores Ocular Pain score - Week 8	-1.9 score on a scale Standard Error 1.11	-1.9 score on a scale Standard Error 1.11	-1.8 score on a scale Standard Error 1.09

SECONDARY outcome

Timeframe: Week 8 (V5)

Corneal fluorescein staining examination was performed at the slit-lamp using blue light. Corneal fluorescein staining was graded according to the NEI scale (5 zones, each zone scoring 0-3, with a total score ranging 0-15, with a higher number representing more staining). The five cornea zones are: central, superior, inferior, nasal and temporal. To avoid the phenomenon of quenching, which is increased in participants with dry eye, staining was assessed after 2-5 minutes from fluorescein instillation for fTBUT evaluation. Missing data for corneal fluorescein staining were imputed employing an MI based on copy-reference approach assuming MNAR. Adjusted means are reported.

Outcome measures

Outcome measures
Measure	Vehicle n=104 Participants Vehicle (Placebo solution): Eye drop solution, containing no rhNGF. 1 drop of vehicle in each eye TID at approximately 6-hour intervals, for 4 weeks of treatment.	rhNGF 5 μg/mL n=106 Participants IMP1: rhNGF 5 μg/mL - 1 drop of rhNGF ophthalmic solution at 5 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.	rhNGF 10 μg/mL n=106 Participants IMP2: rhNGF 10 μg/mL - 1 drop of rhNGF ophthalmic solution at 10 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.
Mean Change From Baseline to Week 8 in Total Corneal Fluorescein Staining (National Eye Institute NEI Scale) in the Study Eye as Assessed by the Investigator	-0.9 score on a scale Standard Error 0.24	-1.2 score on a scale Standard Error 0.24	-0.9 score on a scale Standard Error 0.24

SECONDARY outcome

Timeframe: Week 4 (V4) and week 8 (V5)

The Symptom Assessment in Dry Eye (SANDE) questionnaire was a short questionnaire to evaluate both dry eye intensity/severity and frequency. This questionnaire used a 100 mm horizontal line (Visual Analogue Scale - VAS) for each of the 2 questions to assess ocular discomfort and/or dryness experienced by the patients. In the SANDE questionnaire, frequency of symptoms ranges from "rarely" to "all of the time" and the severity of symptoms ranged from "very mild" to "very severe". Patients were asked to place a mark on the two given lines based on the extent of their symptoms. The locations of the marks was measured in mm from left to right and recorded as frequency and severity scores, respectively. The SANDE scale ranged from 0, being the minimal amount of dry eye symptoms (best outcome) to 100, being the maximal amount of dry eye symptoms (worst outcome). In this outcome severity score was assessed. MI was applied. Adjusted means are reported.

Outcome measures

Outcome measures
Measure	Vehicle n=104 Participants Vehicle (Placebo solution): Eye drop solution, containing no rhNGF. 1 drop of vehicle in each eye TID at approximately 6-hour intervals, for 4 weeks of treatment.	rhNGF 5 μg/mL n=106 Participants IMP1: rhNGF 5 μg/mL - 1 drop of rhNGF ophthalmic solution at 5 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.	rhNGF 10 μg/mL n=106 Participants IMP2: rhNGF 10 μg/mL - 1 drop of rhNGF ophthalmic solution at 10 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.
Mean Change From Baseline to Weeks 4 and 8 in Symptoms Questionnaire (SANDE) Scores for Severity Week 4 - Severity	-12.9 score on a scale Standard Error 2.04	-12.2 score on a scale Standard Error 2.03	-12.9 score on a scale Standard Error 2.05
Mean Change From Baseline to Weeks 4 and 8 in Symptoms Questionnaire (SANDE) Scores for Severity Week 8 - Severity	-14.6 score on a scale Standard Error 2.04	-18.7 score on a scale Standard Error 2.05	-20.6 score on a scale Standard Error 2.07

SECONDARY outcome

Timeframe: Week 4 (V4) and week 8 (V5)

SANDE was a short questionnaire to evaluate both dry eye intensity and frequency. It uses a 100 mm horizontal line (Visual Analogue Scale, VAS), for each of the 2 questions, to assess ocular discomfort and/or dryness. Frequency of symptoms ranged from "rarely" (best outcome) to "all of the time" (worst outcome), while the severity of symptoms ranged from "very mild" (best outcome) to "very severe" (worst outcome). Patients had to place a mark on the two given lines based on the extent of their symptoms. The locations of the marks was measured in mm from left to right and recorded as frequency and severity scores, respectively. The SANDE lines for intensity and for severity ranged from 0, being the minimal amount of dry eye symptoms (best outcome) to 100, being the maximal amount of dry eye symptoms (worst outcome). In this outcome frequency score was assessed. MI was applied. Adjusted means are reported.

Outcome measures

Outcome measures
Measure	Vehicle n=104 Participants Vehicle (Placebo solution): Eye drop solution, containing no rhNGF. 1 drop of vehicle in each eye TID at approximately 6-hour intervals, for 4 weeks of treatment.	rhNGF 5 μg/mL n=106 Participants IMP1: rhNGF 5 μg/mL - 1 drop of rhNGF ophthalmic solution at 5 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.	rhNGF 10 μg/mL n=106 Participants IMP2: rhNGF 10 μg/mL - 1 drop of rhNGF ophthalmic solution at 10 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.
Mean Change From Baseline to Weeks 4 and 8 in Symptoms Questionnaire (SANDE) Scores for Frequency Week 4 - Frequency	-13.8 score on a scale Standard Error 2.02	-13.4 score on a scale Standard Error 2.01	-13.3 score on a scale Standard Error 2.03
Mean Change From Baseline to Weeks 4 and 8 in Symptoms Questionnaire (SANDE) Scores for Frequency Week 8 - Frequency	-15.9 score on a scale Standard Error 2.1	-20.4 score on a scale Standard Error 2.10	-20.3 score on a scale Standard Error 2.13

SECONDARY outcome

Timeframe: Week 4 (V4)

SANDE questionnaire included 2 VAS-based questions that assessed: (i) DED symptom frequency (from 0 to 100) (ii) DED symptom severity (from 0 to 100) compiled by the participants. The global SANDE score (from 0 to 100, with 100 representing the most frequent and severe dry eye symptoms) was calculated by multiplying the frequency score by the severity score and obtaining the square root. For SANDE global Score, the lower the score, the better the outcome. Adjusted means are reported. Data here reported are the data after having applied the predefined strategy to handle intercurrent events (i.e. data for SANDE collected in the week after an administration of a prohibited medication are set to missing under the hypothetical strategy while a treatment policy strategy is used for any other intercurrent event). Missing data for SANDE Global Score are imputed employing Multiple Imputation based on copy-reference approach assuming MNAR. Adjusted means are reported.

Outcome measures

Outcome measures
Measure	Vehicle n=104 Participants Vehicle (Placebo solution): Eye drop solution, containing no rhNGF. 1 drop of vehicle in each eye TID at approximately 6-hour intervals, for 4 weeks of treatment.	rhNGF 5 μg/mL n=106 Participants IMP1: rhNGF 5 μg/mL - 1 drop of rhNGF ophthalmic solution at 5 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.	rhNGF 10 μg/mL n=106 Participants IMP2: rhNGF 10 μg/mL - 1 drop of rhNGF ophthalmic solution at 10 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.
Mean Change From Baseline to Week 4 in Symptoms of Dry Eye Assessed by SANDE Global Score	-13.4 score on a scale Standard Error 1.97	-12.3 score on a scale Standard Error 1.98	-13.8 score on a scale Standard Error 1.97

SECONDARY outcome

Timeframe: Week 4 (V4) and Week 8 (V5)

The BCDVA score is measured by ETDRS letter score. The score is given by the total number of letters read at 4-m distance. If 20 or more letters are read, then the score is given by the total number of letters read + 30. If less than 20 letters are read at 4-m distance, the score is given by the sum of the letters read at 4-m distance and the letters read at 1-m distance. The equivalent logMAR score is given by: logMAR = 1.7 - (0.02) x (ETDRS letter score). The higher the score the better the outcome. MI was applied. Adjusted means are reported.

Outcome measures

Outcome measures
Measure	Vehicle n=104 Participants Vehicle (Placebo solution): Eye drop solution, containing no rhNGF. 1 drop of vehicle in each eye TID at approximately 6-hour intervals, for 4 weeks of treatment.	rhNGF 5 μg/mL n=106 Participants IMP1: rhNGF 5 μg/mL - 1 drop of rhNGF ophthalmic solution at 5 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.	rhNGF 10 μg/mL n=106 Participants IMP2: rhNGF 10 μg/mL - 1 drop of rhNGF ophthalmic solution at 10 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.
Mean Change From Baseline to Weeks 4 and 8 in Best Corrected Distance Visual Acuity (BCDVA) Score in Study Eye Week 4	0.3 score on a scale Standard Error 0.45	1.0 score on a scale Standard Error 0.44	-0.2 score on a scale Standard Error 0.45
Mean Change From Baseline to Weeks 4 and 8 in Best Corrected Distance Visual Acuity (BCDVA) Score in Study Eye Week 8	0.6 score on a scale Standard Error 0.50	0.7 score on a scale Standard Error 0.49	0.7 score on a scale Standard Error 0.50

SECONDARY outcome

Timeframe: Throughout the study, from baseline to the end of trial (Week 8,V5)

TEAEs were defined as adverse events that were reported or worsened on or after the first dose of study treatment. Safety results are provided for overall (ocular and non-ocular) and separately for ocular and non-ocular adverse events.

Outcome measures

Outcome measures
Measure	Vehicle n=104 Participants Vehicle (Placebo solution): Eye drop solution, containing no rhNGF. 1 drop of vehicle in each eye TID at approximately 6-hour intervals, for 4 weeks of treatment.	rhNGF 5 μg/mL n=106 Participants IMP1: rhNGF 5 μg/mL - 1 drop of rhNGF ophthalmic solution at 5 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.	rhNGF 10 μg/mL n=106 Participants IMP2: rhNGF 10 μg/mL - 1 drop of rhNGF ophthalmic solution at 10 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.
Safety Outcome: Incidence of theTreatment-Emergent Adverse Events (TEAEs) Overall (Ocular and Non-ocular) Assessed Throughout the Study Any Ocular Adverse Event	11 Participants	27 Participants	32 Participants
Safety Outcome: Incidence of theTreatment-Emergent Adverse Events (TEAEs) Overall (Ocular and Non-ocular) Assessed Throughout the Study Any Ocular Adverse Event Related to Study Drug	5 Participants	23 Participants	26 Participants
Safety Outcome: Incidence of theTreatment-Emergent Adverse Events (TEAEs) Overall (Ocular and Non-ocular) Assessed Throughout the Study Any ocular AESI	0 Participants	0 Participants	0 Participants
Safety Outcome: Incidence of theTreatment-Emergent Adverse Events (TEAEs) Overall (Ocular and Non-ocular) Assessed Throughout the Study Any ocular Serious Adverse Event	0 Participants	0 Participants	0 Participants
Safety Outcome: Incidence of theTreatment-Emergent Adverse Events (TEAEs) Overall (Ocular and Non-ocular) Assessed Throughout the Study Any ocular Serious Adverse Event Related to Study Drug	0 Participants	0 Participants	0 Participants
Safety Outcome: Incidence of theTreatment-Emergent Adverse Events (TEAEs) Overall (Ocular and Non-ocular) Assessed Throughout the Study Any ocular Adverse Event Leading to Treatment Discontinuation	0 Participants	1 Participants	7 Participants
Safety Outcome: Incidence of theTreatment-Emergent Adverse Events (TEAEs) Overall (Ocular and Non-ocular) Assessed Throughout the Study Any ocular Adverse Event Leading to Study Discontinuation	0 Participants	0 Participants	3 Participants
Safety Outcome: Incidence of theTreatment-Emergent Adverse Events (TEAEs) Overall (Ocular and Non-ocular) Assessed Throughout the Study Any ocular Adverse Event Leading to Death	0 Participants	0 Participants	0 Participants
Safety Outcome: Incidence of theTreatment-Emergent Adverse Events (TEAEs) Overall (Ocular and Non-ocular) Assessed Throughout the Study Any non-ocular Adverse Event	9 Participants	8 Participants	10 Participants
Safety Outcome: Incidence of theTreatment-Emergent Adverse Events (TEAEs) Overall (Ocular and Non-ocular) Assessed Throughout the Study Any non-ocular Adverse Event Related to Study Drug	2 Participants	1 Participants	5 Participants
Safety Outcome: Incidence of theTreatment-Emergent Adverse Events (TEAEs) Overall (Ocular and Non-ocular) Assessed Throughout the Study Any non-ocular AESI	0 Participants	0 Participants	0 Participants
Safety Outcome: Incidence of theTreatment-Emergent Adverse Events (TEAEs) Overall (Ocular and Non-ocular) Assessed Throughout the Study Any non-ocular Serious Adverse Event	1 Participants	2 Participants	0 Participants
Safety Outcome: Incidence of theTreatment-Emergent Adverse Events (TEAEs) Overall (Ocular and Non-ocular) Assessed Throughout the Study Any non-ocular Serious Adverse Event Related to Study Drug	0 Participants	0 Participants	0 Participants
Safety Outcome: Incidence of theTreatment-Emergent Adverse Events (TEAEs) Overall (Ocular and Non-ocular) Assessed Throughout the Study Any non-ocular Adverse Event Leading to Treatment Discontinuation	0 Participants	0 Participants	0 Participants
Safety Outcome: Incidence of theTreatment-Emergent Adverse Events (TEAEs) Overall (Ocular and Non-ocular) Assessed Throughout the Study Any non-ocular Adverse Event Leading to Study Discontinuation	1 Participants	0 Participants	0 Participants
Safety Outcome: Incidence of theTreatment-Emergent Adverse Events (TEAEs) Overall (Ocular and Non-ocular) Assessed Throughout the Study Any non-ocular Adverse Event Leading to Death	0 Participants	0 Participants	0 Participants
Safety Outcome: Incidence of theTreatment-Emergent Adverse Events (TEAEs) Overall (Ocular and Non-ocular) Assessed Throughout the Study Any overall Adverse Event	19 Participants	32 Participants	35 Participants
Safety Outcome: Incidence of theTreatment-Emergent Adverse Events (TEAEs) Overall (Ocular and Non-ocular) Assessed Throughout the Study Any overall Adverse Event Related to Study Drug	7 Participants	23 Participants	27 Participants
Safety Outcome: Incidence of theTreatment-Emergent Adverse Events (TEAEs) Overall (Ocular and Non-ocular) Assessed Throughout the Study Any overall AESI	0 Participants	0 Participants	0 Participants
Safety Outcome: Incidence of theTreatment-Emergent Adverse Events (TEAEs) Overall (Ocular and Non-ocular) Assessed Throughout the Study Any overall Serious Adverse Event	1 Participants	2 Participants	0 Participants
Safety Outcome: Incidence of theTreatment-Emergent Adverse Events (TEAEs) Overall (Ocular and Non-ocular) Assessed Throughout the Study Any overall Serious Adverse Event Related to Study Drug	0 Participants	0 Participants	0 Participants
Safety Outcome: Incidence of theTreatment-Emergent Adverse Events (TEAEs) Overall (Ocular and Non-ocular) Assessed Throughout the Study Any overall Adverse Event Leading to Treatment Discontinuation	0 Participants	1 Participants	7 Participants
Safety Outcome: Incidence of theTreatment-Emergent Adverse Events (TEAEs) Overall (Ocular and Non-ocular) Assessed Throughout the Study Any Adverse Event Leading to Study Discontinuation	1 Participants	0 Participants	3 Participants
Safety Outcome: Incidence of theTreatment-Emergent Adverse Events (TEAEs) Overall (Ocular and Non-ocular) Assessed Throughout the Study Any overall Adverse Event Leading to Death	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Throughout the study, including run-in period

TEAEs were defined as adverse events that were reported or worsened on or after the first dose of study treatment. Most frequently reported ocular adverse events (reported in \> 1 participant in the total group) are reported here: at participant's level, for the "on treatment" and for the "follow-up" periods, while most frequently reported non-ocular adverse events (reported in \> 1 participant in the total group) are reported at patient level for the overall period.

Outcome measures

Outcome measures
Measure	Vehicle n=104 Participants Vehicle (Placebo solution): Eye drop solution, containing no rhNGF. 1 drop of vehicle in each eye TID at approximately 6-hour intervals, for 4 weeks of treatment.	rhNGF 5 μg/mL n=106 Participants IMP1: rhNGF 5 μg/mL - 1 drop of rhNGF ophthalmic solution at 5 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.	rhNGF 10 μg/mL n=106 Participants IMP2: rhNGF 10 μg/mL - 1 drop of rhNGF ophthalmic solution at 10 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.
Safety Outcome: Frequency of the Treatment-Emergent Adverse Events (TEAEs) (Ocular and Non-ocular) at Participant Level, Assessed Throughout the Study Including run-in Period Non ocular - overall period - Respiratory, thoracic and mediastinal disorders - Rhinorrhoea	1 Participants	0 Participants	1 Participants
Safety Outcome: Frequency of the Treatment-Emergent Adverse Events (TEAEs) (Ocular and Non-ocular) at Participant Level, Assessed Throughout the Study Including run-in Period Ocular - On treatment period - Eye pain	5 Participants	11 Participants	20 Participants
Safety Outcome: Frequency of the Treatment-Emergent Adverse Events (TEAEs) (Ocular and Non-ocular) at Participant Level, Assessed Throughout the Study Including run-in Period Ocular - On treatment period - Eyelid pain	0 Participants	10 Participants	6 Participants
Safety Outcome: Frequency of the Treatment-Emergent Adverse Events (TEAEs) (Ocular and Non-ocular) at Participant Level, Assessed Throughout the Study Including run-in Period Ocular - On treatment period - Eye irritation	1 Participants	2 Participants	1 Participants
Safety Outcome: Frequency of the Treatment-Emergent Adverse Events (TEAEs) (Ocular and Non-ocular) at Participant Level, Assessed Throughout the Study Including run-in Period Ocular - On treatment period - Photophobia	1 Participants	2 Participants	3 Participants
Safety Outcome: Frequency of the Treatment-Emergent Adverse Events (TEAEs) (Ocular and Non-ocular) at Participant Level, Assessed Throughout the Study Including run-in Period Ocular - On treatment period - Ocular hyperaemia	1 Participants	3 Participants	1 Participants
Safety Outcome: Frequency of the Treatment-Emergent Adverse Events (TEAEs) (Ocular and Non-ocular) at Participant Level, Assessed Throughout the Study Including run-in Period Ocular - On treatment period - Periorbital Pain	1 Participants	1 Participants	2 Participants
Safety Outcome: Frequency of the Treatment-Emergent Adverse Events (TEAEs) (Ocular and Non-ocular) at Participant Level, Assessed Throughout the Study Including run-in Period Ocular - On treatment period - Vision blurred	0 Participants	2 Participants	2 Participants
Safety Outcome: Frequency of the Treatment-Emergent Adverse Events (TEAEs) (Ocular and Non-ocular) at Participant Level, Assessed Throughout the Study Including run-in Period Ocular - On treatment period - Eyelids pruritus	1 Participants	1 Participants	0 Participants
Safety Outcome: Frequency of the Treatment-Emergent Adverse Events (TEAEs) (Ocular and Non-ocular) at Participant Level, Assessed Throughout the Study Including run-in Period Ocular - On treatment period - Eyelid sensory disorder	0 Participants	2 Participants	0 Participants
Safety Outcome: Frequency of the Treatment-Emergent Adverse Events (TEAEs) (Ocular and Non-ocular) at Participant Level, Assessed Throughout the Study Including run-in Period Ocular - On treatment period - - Foreign body sensation in eyes	0 Participants	2 Participants	0 Participants
Safety Outcome: Frequency of the Treatment-Emergent Adverse Events (TEAEs) (Ocular and Non-ocular) at Participant Level, Assessed Throughout the Study Including run-in Period Ocular - On treatment period - Iritis	0 Participants	1 Participants	1 Participants
Safety Outcome: Frequency of the Treatment-Emergent Adverse Events (TEAEs) (Ocular and Non-ocular) at Participant Level, Assessed Throughout the Study Including run-in Period Ocular - On treatment period - Lacrimation increased	1 Participants	1 Participants	0 Participants
Safety Outcome: Frequency of the Treatment-Emergent Adverse Events (TEAEs) (Ocular and Non-ocular) at Participant Level, Assessed Throughout the Study Including run-in Period Ocular - On treatment period - Swelling of eyelid	1 Participants	0 Participants	1 Participants
Safety Outcome: Frequency of the Treatment-Emergent Adverse Events (TEAEs) (Ocular and Non-ocular) at Participant Level, Assessed Throughout the Study Including run-in Period Ocular - follow-up period - Eye pain	1 Participants	1 Participants	1 Participants
Safety Outcome: Frequency of the Treatment-Emergent Adverse Events (TEAEs) (Ocular and Non-ocular) at Participant Level, Assessed Throughout the Study Including run-in Period Ocular - follow-up period - eye irritation	1 Participants	1 Participants	1 Participants
Safety Outcome: Frequency of the Treatment-Emergent Adverse Events (TEAEs) (Ocular and Non-ocular) at Participant Level, Assessed Throughout the Study Including run-in Period Ocular - follow-up period - periorbital pain	0 Participants	1 Participants	1 Participants
Safety Outcome: Frequency of the Treatment-Emergent Adverse Events (TEAEs) (Ocular and Non-ocular) at Participant Level, Assessed Throughout the Study Including run-in Period Non ocular - overall period - infections and infestation - COVID19	2 Participants	0 Participants	1 Participants
Safety Outcome: Frequency of the Treatment-Emergent Adverse Events (TEAEs) (Ocular and Non-ocular) at Participant Level, Assessed Throughout the Study Including run-in Period Non ocular - overall period - nervous system disorders - Headache	1 Participants	1 Participants	3 Participants
Safety Outcome: Frequency of the Treatment-Emergent Adverse Events (TEAEs) (Ocular and Non-ocular) at Participant Level, Assessed Throughout the Study Including run-in Period Non ocular - overall period - ear and labyrinth disorder - ear pain	1 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Week 8 (V5)

Corneal Endothelial Cell Density (ECD) is a measure of the number of cells per square millimeter in the innermost layer of the cornea, which is crucial for maintaining corneal transparency and hydration. ECD is typically highest at birth (around 3,000 cells/mm2) and decreases with age, reaching approximately 2,500 cells/mm2) in adulthood. A critical minimum of 400-500 cells/mm2 is required to maintain proper function, and if the density falls below this level, it can lead to corneal edema and reduced vision. Results (absolute values and change from baseline) were summarized using descriptive statistics at each scheduled visit for both eyes. Herenuder only mean change from baseline to week 8 is reported.

Outcome measures

Outcome measures
Measure	Vehicle n=87 Pts with values at baseline&postbaseline Vehicle (Placebo solution): Eye drop solution, containing no rhNGF. 1 drop of vehicle in each eye TID at approximately 6-hour intervals, for 4 weeks of treatment.	rhNGF 5 μg/mL n=85 Pts with values at baseline&postbaseline IMP1: rhNGF 5 μg/mL - 1 drop of rhNGF ophthalmic solution at 5 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.	rhNGF 10 μg/mL n=82 Pts with values at baseline&postbaseline IMP2: rhNGF 10 μg/mL - 1 drop of rhNGF ophthalmic solution at 10 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.
Safety Outcome: Mean Change From Baseline to Week 8 in Corneal Endothelial Cell Density in Both Eyes (Study Eye and Fellow Eye) Fellow eye	11.7 cells/mm^2 Standard Deviation 176.93	27.3 cells/mm^2 Standard Deviation 174.19	-14.9 cells/mm^2 Standard Deviation 150.24
Safety Outcome: Mean Change From Baseline to Week 8 in Corneal Endothelial Cell Density in Both Eyes (Study Eye and Fellow Eye) Study eye	10.5 cells/mm^2 Standard Deviation 134.59	-3.0 cells/mm^2 Standard Deviation 134.57	-16.9 cells/mm^2 Standard Deviation 118.05

SECONDARY outcome

Timeframe: Week 8 (V5)

Population: The Safety analysis set (SAF) consisted of all participants in the RND analysis set who received at least 1 dose of the investigational product. The SAF was analyzed according to the actual treatment received. The SAF was used to present results on safety data. These results are based on number of patients with no missing value in each category (i.e. visit by treatment group).

A summary of dilated fundoscopy (DFE) results at week 8 for the following parameters: maculopathy, posterior vitreous detachment, optic nerve abnormal appearance, retinal or virtual hemorrhage, vitritis, in the SAF is presented for the study eye and for the fellow eye.

Outcome measures

Outcome measures
Measure	Vehicle n=103 Participants Vehicle (Placebo solution): Eye drop solution, containing no rhNGF. 1 drop of vehicle in each eye TID at approximately 6-hour intervals, for 4 weeks of treatment.	rhNGF 5 μg/mL n=101 Participants IMP1: rhNGF 5 μg/mL - 1 drop of rhNGF ophthalmic solution at 5 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.	rhNGF 10 μg/mL n=97 Participants IMP2: rhNGF 10 μg/mL - 1 drop of rhNGF ophthalmic solution at 10 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.
Safety Outcome: Percentage of Participants With Vitritis, Retinal or Vitreal Hemorrhages, Retinal or Posterior Vitreal Detachment, Retinal Tears, Maculopathy on Dilated Fundus Exam (DFE) in Both Eyes at Week 8 Study Eye - Vitritis - Present	0 Participants	0 Participants	1 Participants
Safety Outcome: Percentage of Participants With Vitritis, Retinal or Vitreal Hemorrhages, Retinal or Posterior Vitreal Detachment, Retinal Tears, Maculopathy on Dilated Fundus Exam (DFE) in Both Eyes at Week 8 Study Eye - Vitreal Hemorrage - Present	0 Participants	0 Participants	0 Participants
Safety Outcome: Percentage of Participants With Vitritis, Retinal or Vitreal Hemorrhages, Retinal or Posterior Vitreal Detachment, Retinal Tears, Maculopathy on Dilated Fundus Exam (DFE) in Both Eyes at Week 8 Study Eye - Retinal Hemorrage - Present	0 Participants	0 Participants	1 Participants
Safety Outcome: Percentage of Participants With Vitritis, Retinal or Vitreal Hemorrhages, Retinal or Posterior Vitreal Detachment, Retinal Tears, Maculopathy on Dilated Fundus Exam (DFE) in Both Eyes at Week 8 Study Eye - Maculopathy - Present	2 Participants	2 Participants	2 Participants
Safety Outcome: Percentage of Participants With Vitritis, Retinal or Vitreal Hemorrhages, Retinal or Posterior Vitreal Detachment, Retinal Tears, Maculopathy on Dilated Fundus Exam (DFE) in Both Eyes at Week 8 Study Eye - Retinal Tears - Present	0 Participants	0 Participants	0 Participants
Safety Outcome: Percentage of Participants With Vitritis, Retinal or Vitreal Hemorrhages, Retinal or Posterior Vitreal Detachment, Retinal Tears, Maculopathy on Dilated Fundus Exam (DFE) in Both Eyes at Week 8 Study Eye - Retinal Detachment - Present	0 Participants	0 Participants	0 Participants
Safety Outcome: Percentage of Participants With Vitritis, Retinal or Vitreal Hemorrhages, Retinal or Posterior Vitreal Detachment, Retinal Tears, Maculopathy on Dilated Fundus Exam (DFE) in Both Eyes at Week 8 Study Eye - Posterior Vitreous Detachment - Present	13 Participants	13 Participants	15 Participants
Safety Outcome: Percentage of Participants With Vitritis, Retinal or Vitreal Hemorrhages, Retinal or Posterior Vitreal Detachment, Retinal Tears, Maculopathy on Dilated Fundus Exam (DFE) in Both Eyes at Week 8 Study Eye - Optic Nerve Appearance - Normal	0 Participants	0 Participants	0 Participants
Safety Outcome: Percentage of Participants With Vitritis, Retinal or Vitreal Hemorrhages, Retinal or Posterior Vitreal Detachment, Retinal Tears, Maculopathy on Dilated Fundus Exam (DFE) in Both Eyes at Week 8 Study Eye - Optic Nerve Appearance - Abnormal	3 Participants	2 Participants	1 Participants
Safety Outcome: Percentage of Participants With Vitritis, Retinal or Vitreal Hemorrhages, Retinal or Posterior Vitreal Detachment, Retinal Tears, Maculopathy on Dilated Fundus Exam (DFE) in Both Eyes at Week 8 Fellow Eye - Vitritis - Present	0 Participants	0 Participants	2 Participants
Safety Outcome: Percentage of Participants With Vitritis, Retinal or Vitreal Hemorrhages, Retinal or Posterior Vitreal Detachment, Retinal Tears, Maculopathy on Dilated Fundus Exam (DFE) in Both Eyes at Week 8 Fellow Eye - Vitreal Hemorrhage - Present	0 Participants	0 Participants	0 Participants
Safety Outcome: Percentage of Participants With Vitritis, Retinal or Vitreal Hemorrhages, Retinal or Posterior Vitreal Detachment, Retinal Tears, Maculopathy on Dilated Fundus Exam (DFE) in Both Eyes at Week 8 Fellow Eye - Retinal Hemorrhage - Present	0 Participants	0 Participants	1 Participants
Safety Outcome: Percentage of Participants With Vitritis, Retinal or Vitreal Hemorrhages, Retinal or Posterior Vitreal Detachment, Retinal Tears, Maculopathy on Dilated Fundus Exam (DFE) in Both Eyes at Week 8 Fellow Eye - Maculopathy - Present	3 Participants	2 Participants	2 Participants
Safety Outcome: Percentage of Participants With Vitritis, Retinal or Vitreal Hemorrhages, Retinal or Posterior Vitreal Detachment, Retinal Tears, Maculopathy on Dilated Fundus Exam (DFE) in Both Eyes at Week 8 Fellow Eye - Retinal Tears - Present	0 Participants	0 Participants	0 Participants
Safety Outcome: Percentage of Participants With Vitritis, Retinal or Vitreal Hemorrhages, Retinal or Posterior Vitreal Detachment, Retinal Tears, Maculopathy on Dilated Fundus Exam (DFE) in Both Eyes at Week 8 Fellow Eye - Retinal Detachment - Present	0 Participants	0 Participants	0 Participants
Safety Outcome: Percentage of Participants With Vitritis, Retinal or Vitreal Hemorrhages, Retinal or Posterior Vitreal Detachment, Retinal Tears, Maculopathy on Dilated Fundus Exam (DFE) in Both Eyes at Week 8 Fellow Eye - Posterior Vitreous Detachment - Present	15 Participants	14 Participants	16 Participants
Safety Outcome: Percentage of Participants With Vitritis, Retinal or Vitreal Hemorrhages, Retinal or Posterior Vitreal Detachment, Retinal Tears, Maculopathy on Dilated Fundus Exam (DFE) in Both Eyes at Week 8 Fellow Eye - Optic Nerve Appearance - Normal	0 Participants	0 Participants	0 Participants
Safety Outcome: Percentage of Participants With Vitritis, Retinal or Vitreal Hemorrhages, Retinal or Posterior Vitreal Detachment, Retinal Tears, Maculopathy on Dilated Fundus Exam (DFE) in Both Eyes at Week 8 Fellow Eye - Optic Nerve Appearance - Abnormal	3 Participants	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Week 8 (V5)

Change from baseline in cup-to-disc ratio in the SAF population is presented for the study eye and for the fellow eye. An increased cup-to-disc ratio means the "cup" (the central depression) of the optic nerve is larger relative to the "disc" (the entire nerve head), which can indicate a loss of nerve fibers and is often a sign of glaucoma. An increase in this ratio may indicate a decrease in the quantity of healthy neuroretinal cells. For the change from baseline, only patients with a value at both baseline visit and the postbaseline visit are included.

Outcome measures

Outcome measures
Measure	Vehicle n=104 Participants Vehicle (Placebo solution): Eye drop solution, containing no rhNGF. 1 drop of vehicle in each eye TID at approximately 6-hour intervals, for 4 weeks of treatment.	rhNGF 5 μg/mL n=106 Participants IMP1: rhNGF 5 μg/mL - 1 drop of rhNGF ophthalmic solution at 5 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.	rhNGF 10 μg/mL n=106 Participants IMP2: rhNGF 10 μg/mL - 1 drop of rhNGF ophthalmic solution at 10 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.
Safety Outcome: Change From Baseline to Week 8 in Cup-to-disc Ratio in Both Eyes Study Eye	0.00 ratio Standard Deviation 0.030	0.02 ratio Standard Deviation 0.188	0.02 ratio Standard Deviation 0.188
Safety Outcome: Change From Baseline to Week 8 in Cup-to-disc Ratio in Both Eyes Fellow Eye	0.00 ratio Standard Deviation 0.025	0.02 ratio Standard Deviation 0.185	0.02 ratio Standard Deviation 0.190

SECONDARY outcome

Timeframe: Weeks 4 (V4) and 8 (V5)

Bulbar conjunctival redness was assessed at the slit-lamp using white light prior to vital dye instillation and graded according to the Validate Bulbar Redness (VBR 10) scale. The scale starts at grade 10 and has 10-point steps between reference images (score range 10-100). The VBR scale ranges from 10 to 100 with a higher score meaning more severe redness. The ocular areas where the redness is assessed for the study eye and the fellow eye are: * Nasal conjunctiva * Temporal conjunctiva Please note that the results (absolute values and change from baseline) were summarized by conjunctiva, visit and eye using descriptive statistics.

Outcome measures

Outcome measures
Measure	Vehicle n=104 Participants Vehicle (Placebo solution): Eye drop solution, containing no rhNGF. 1 drop of vehicle in each eye TID at approximately 6-hour intervals, for 4 weeks of treatment.	rhNGF 5 μg/mL n=106 Participants IMP1: rhNGF 5 μg/mL - 1 drop of rhNGF ophthalmic solution at 5 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.	rhNGF 10 μg/mL n=106 Participants IMP2: rhNGF 10 μg/mL - 1 drop of rhNGF ophthalmic solution at 10 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.
Safety Outcome: Mean Change From Baseline to Weeks 4 and 8 in Bulbar Conjunctival Redness (VBR 10 Score) in Both Eyes week 4 - Nasal conjuntiva - study eye	-2.7 score on a scale Standard Deviation 11.70	-2.3 score on a scale Standard Deviation 9.72	-1.5 score on a scale Standard Deviation 11.14
Safety Outcome: Mean Change From Baseline to Weeks 4 and 8 in Bulbar Conjunctival Redness (VBR 10 Score) in Both Eyes week 4 - Temporal conjunctiva - study eye	-2.5 score on a scale Standard Deviation 13.01	-2.0 score on a scale Standard Deviation 9.74	-0.6 score on a scale Standard Deviation 11.08
Safety Outcome: Mean Change From Baseline to Weeks 4 and 8 in Bulbar Conjunctival Redness (VBR 10 Score) in Both Eyes week 8 - Nasal conjuntiva - study eye	-1.7 score on a scale Standard Deviation 12.32	-3.0 score on a scale Standard Deviation 10.22	-2.6 score on a scale Standard Deviation 10.75
Safety Outcome: Mean Change From Baseline to Weeks 4 and 8 in Bulbar Conjunctival Redness (VBR 10 Score) in Both Eyes week 8 - Temporal conjunctiva - study eye	-3.6 score on a scale Standard Deviation 12.17	-3.2 score on a scale Standard Deviation 10.73	-2.5 score on a scale Standard Deviation 11.55
Safety Outcome: Mean Change From Baseline to Weeks 4 and 8 in Bulbar Conjunctival Redness (VBR 10 Score) in Both Eyes week 4 - Nasal conjuntiva - fellow eye	-2.3 score on a scale Standard Deviation 11.77	-0.8 score on a scale Standard Deviation 9.67	-0.8 score on a scale Standard Deviation 11.92
Safety Outcome: Mean Change From Baseline to Weeks 4 and 8 in Bulbar Conjunctival Redness (VBR 10 Score) in Both Eyes week 4 - Temporal conjunctiva - fellow eye	-2.4 score on a scale Standard Deviation 13.80	-1.4 score on a scale Standard Deviation 9.91	-1.3 score on a scale Standard Deviation 12.53
Safety Outcome: Mean Change From Baseline to Weeks 4 and 8 in Bulbar Conjunctival Redness (VBR 10 Score) in Both Eyes week 8 - Nasal conjuntiva - fellow eye	-2.2 score on a scale Standard Deviation 11.11	-2.0 score on a scale Standard Deviation 8.56	-2.3 score on a scale Standard Deviation 10.86
Safety Outcome: Mean Change From Baseline to Weeks 4 and 8 in Bulbar Conjunctival Redness (VBR 10 Score) in Both Eyes week 8 - Temporal conjunctiva - fellow eye	-3.2 score on a scale Standard Deviation 12.06	-3.9 score on a scale Standard Deviation 10.16	-3.2 score on a scale Standard Deviation 12.68

SECONDARY outcome

Timeframe: Throughout the study till week 8 (V5)

The number and percentage of participants who discontinued study treatment due to tolerability were summarized as recorded in the eCRF EOT page.

Outcome measures

Outcome measures
Measure	Vehicle n=104 Participants Vehicle (Placebo solution): Eye drop solution, containing no rhNGF. 1 drop of vehicle in each eye TID at approximately 6-hour intervals, for 4 weeks of treatment.	rhNGF 5 μg/mL n=106 Participants IMP1: rhNGF 5 μg/mL - 1 drop of rhNGF ophthalmic solution at 5 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.	rhNGF 10 μg/mL n=106 Participants IMP2: rhNGF 10 μg/mL - 1 drop of rhNGF ophthalmic solution at 10 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.
Percentage of Participants Who Discontinued the Treatment Due to Tolerability Issues	0 percentage of participants	0 percentage of participants	0 percentage of participants

Adverse Events

Ocular rhNGF 5 μg/mL (SAF)

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Ocular rhNGF 10 μg/mL (SAF)

Serious events: 0 serious events

Other events: 32 other events

Deaths: 0 deaths

Ocular Vehicle (SAF)

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Non-Ocular rhNGF 5 μg/mL (SAF)

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Non-Ocular rhNGF 10 μg/mL (SAF)

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Non-Ocular Vehicle (SAF)

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ocular rhNGF 5 μg/mL (SAF) n=106 participants at risk IMP1: rhNGF 5 μg/mL - 1 drop of rhNGF ophthalmic solution at 5 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.	Ocular rhNGF 10 μg/mL (SAF) n=106 participants at risk IMP2: rhNGF 10 μg/mL - 1 drop of rhNGF ophthalmic solution at 10 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.	Ocular Vehicle (SAF) n=104 participants at risk Vehicle (Placebo solution): Eye drop solution, containing no rhNGF. 1 drop of vehicle in each eye TID at approximately 6-hour intervals, for 4 weeks of treatment.	Non-Ocular rhNGF 5 μg/mL (SAF) n=106 participants at risk IMP1: rhNGF 5 μg/mL - 1 drop of rhNGF ophthalmic solution at 5 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.	Non-Ocular rhNGF 10 μg/mL (SAF) n=106 participants at risk IMP2: rhNGF 10 μg/mL - 1 drop of rhNGF ophthalmic solution at 10 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.	Non-Ocular Vehicle (SAF) n=104 participants at risk Vehicle (Placebo solution): Eye drop solution, containing no rhNGF. 1 drop of vehicle in each eye TID at approximately 6-hour intervals, for 4 weeks of treatment.
Cardiac disorders Myocardial infarction	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Infections and infestations Cystitis	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Infections and infestations Pyelonephritis	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Renal and urinary disorders Cystitis haemorragic	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
General disorders Non-cardiac chest pain	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.96% 1/104 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.

Other adverse events

Other adverse events
Measure	Ocular rhNGF 5 μg/mL (SAF) n=106 participants at risk IMP1: rhNGF 5 μg/mL - 1 drop of rhNGF ophthalmic solution at 5 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.	Ocular rhNGF 10 μg/mL (SAF) n=106 participants at risk IMP2: rhNGF 10 μg/mL - 1 drop of rhNGF ophthalmic solution at 10 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.	Ocular Vehicle (SAF) n=104 participants at risk Vehicle (Placebo solution): Eye drop solution, containing no rhNGF. 1 drop of vehicle in each eye TID at approximately 6-hour intervals, for 4 weeks of treatment.	Non-Ocular rhNGF 5 μg/mL (SAF) n=106 participants at risk IMP1: rhNGF 5 μg/mL - 1 drop of rhNGF ophthalmic solution at 5 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.	Non-Ocular rhNGF 10 μg/mL (SAF) n=106 participants at risk IMP2: rhNGF 10 μg/mL - 1 drop of rhNGF ophthalmic solution at 10 μg/mL in each eye TID, at approximately 6-hour intervals, for 4 weeks of treatment.	Non-Ocular Vehicle (SAF) n=104 participants at risk Vehicle (Placebo solution): Eye drop solution, containing no rhNGF. 1 drop of vehicle in each eye TID at approximately 6-hour intervals, for 4 weeks of treatment.
Respiratory, thoracic and mediastinal disorders Nasal discomfort	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.96% 1/104 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of skin	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Vascular disorders Hypertension	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Eye disorders Eye pain	11.3% 12/106 • Number of events 12 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	19.8% 21/106 • Number of events 24 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	4.8% 5/104 • Number of events 6 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Eye disorders Eyelid pain	9.4% 10/106 • Number of events 14 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	5.7% 6/106 • Number of events 6 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Eye disorders Photophobia	1.9% 2/106 • Number of events 3 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	2.8% 3/106 • Number of events 3 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.96% 1/104 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Eye disorders Ocular hyperaemia	2.8% 3/106 • Number of events 3 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.96% 1/104 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Eye disorders Eye irritation	2.8% 3/106 • Number of events 3 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	1.9% 2/106 • Number of events 3 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	1.9% 2/104 • Number of events 2 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Eye disorders Periorbital pain	0.94% 1/106 • Number of events 2 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	1.9% 2/106 • Number of events 3 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.96% 1/104 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Eye disorders Vision blurred	1.9% 2/106 • Number of events 2 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	1.9% 2/106 • Number of events 2 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Eye disorders Eyelid sensory disorder	1.9% 2/106 • Number of events 3 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Eye disorders Eyelids pruritus	1.9% 2/106 • Number of events 2 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.96% 1/104 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Eye disorders Foreign body sensation in eyes	1.9% 2/106 • Number of events 2 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Eye disorders Iritis	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Eye disorders Lacrimation increased	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.96% 1/104 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Eye disorders Swelling of eyelid	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.96% 1/104 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Eye disorders Abnormal sensation in eye	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Eye disorders Dry eye	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Eye disorders Episcleritis	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Eye disorders Eye allergy	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.96% 1/104 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Eye disorders Eye pruritus	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	1.9% 2/104 • Number of events 2 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Eye disorders Asthenopia	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Eye disorders Blepharitis	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Eye disorders Conjunctival hemorrhage	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.96% 1/104 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Eye disorders Conjunctivitis allergic	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Eye disorders Erythema of the eyelid	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Eye disorders Eyelid oedema	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Eye disorders Photopsia	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Eye disorders Vitreous detachment	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
General disorders Feeling hot	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
General disorders Instillation site irritation	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Infections and infestations Hordeolum	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Infections and infestations COVID-19	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	1.9% 2/104 • Number of events 2 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Infections and infestations Blister infected	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Infections and infestations Diverticulitis	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.96% 1/104 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Infections and infestations Helicobacter infection	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Infections and infestations Onychomycosis	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Infections and infestations Sinusitis bacterial	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.96% 1/104 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Infections and infestations Upper respiratory tract infection	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Infections and infestations Urinary tract infection	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Nervous system disorders Headache	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	2.8% 3/106 • Number of events 3 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.96% 1/104 • Number of events 2 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Nervous system disorders Migraine	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Nervous system disorders Sensory disturbance	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Ear and labyrinth disorders Ear pain	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.96% 1/104 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Ear and labyrinth disorders Vertigo	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.96% 1/104 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Gastrointestinal disorders Chapped lips	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Gastrointestinal disorders Nausea	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Gastrointestinal disorders Oral pain	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.96% 1/104 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
General disorders Facial pain	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
General disorders Fatigue	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Injury, poisoning and procedural complications Animal bite	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.96% 1/104 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Injury, poisoning and procedural complications Contusion	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Metabolism and nutrition disorders Abnormal weight gain	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Metabolism and nutrition disorders Dehydration	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Metabolism and nutrition disorders Gout	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/104 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.00% 0/106 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.94% 1/106 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.	0.96% 1/104 • Number of events 1 • Throughout the study, from baseline (V2, Day 1) and all treatment period (V3 [Day 13] and V4 [Day 28, EoT]) till the end of follow-up (FU, V5) at Day 56. Treatment emergent adverse events (TEAEs) are reported by system organ class (SOC) and preferred term (PT), for the overall period (treatment period + follow-up) at the patient's level, and separately for Ocular and Non-Ocular AEs.

Additional Information

Clinical Development & Operations

Dompé Farmaceutici S.p.A.

Phone: +39 02 583831

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place