Trial Outcomes & Findings for Study Evaluating the Safety and Efficacy of AR-15512 (COMET-3) (NCT NCT05360966)
NCT ID: NCT05360966
Last Updated: 2025-07-23
Results Overview
The Schirmer test measures tear production using a filter paper placed on the lower eyelid. The amount of wetting was recorded on a scale from 0 millimeters (mm) (no tear production) to 35 mm (maximum). The test was performed at Day 1 prior to drop exposure and at Day 14 following drop exposure. An increased score represents a positive outcome. One eye (study eye) contributed data to the analysis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
467 participants
Primary outcome timeframe
Baseline (Day 1) pre-drop; Day 14 post-drop
Results posted on
2025-07-23
Participant Flow
Participants were recruited from 23 investigative sites located in the United States.
This reporting group includes all randomized participants.
Participant milestones
| Measure |
0.003% AR-15512
0.003% AR-15512 ophthalmic solution, one drop in each eye twice a day for 90 days
|
AR-15512 Vehicle
AR-15512 vehicle ophthalmic solution, one drop in each eye twice a day for 90 days
|
|---|---|---|
|
Overall Study
STARTED
|
232
|
235
|
|
Overall Study
Intent to Treat (ITT) Population
|
232
|
234
|
|
Overall Study
Safety Population
|
232
|
234
|
|
Overall Study
COMPLETED
|
215
|
219
|
|
Overall Study
NOT COMPLETED
|
17
|
16
|
Reasons for withdrawal
| Measure |
0.003% AR-15512
0.003% AR-15512 ophthalmic solution, one drop in each eye twice a day for 90 days
|
AR-15512 Vehicle
AR-15512 vehicle ophthalmic solution, one drop in each eye twice a day for 90 days
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
5
|
|
Overall Study
Withdrawal of Consent
|
5
|
3
|
|
Overall Study
Noncompliance
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
|
Overall Study
Protocol Deviation
|
2
|
1
|
|
Overall Study
As specified in the Clinical Study Report
|
1
|
3
|
Baseline Characteristics
Study Evaluating the Safety and Efficacy of AR-15512 (COMET-3)
Baseline characteristics by cohort
| Measure |
0.003% AR-15512
n=232 Participants
0.003% AR-15512 ophthalmic solution, one drop in each eye twice a day for 90 days
|
AR-15512 Vehicle
n=234 Participants
AR-15512 vehicle ophthalmic solution, one drop in each eye twice a day for 90 days
|
Total
n=466 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.1 years
STANDARD_DEVIATION 12.23 • n=99 Participants
|
62.1 years
STANDARD_DEVIATION 12.19 • n=107 Participants
|
62.6 years
STANDARD_DEVIATION 12.21 • n=206 Participants
|
|
Sex: Female, Male
Female
|
177 Participants
n=99 Participants
|
166 Participants
n=107 Participants
|
343 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=99 Participants
|
68 Participants
n=107 Participants
|
123 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
216 Participants
n=99 Participants
|
206 Participants
n=107 Participants
|
422 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian / Alaska Native
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
16 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black / African American
|
35 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
174 Participants
n=99 Participants
|
186 Participants
n=107 Participants
|
360 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Multi-racial
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
232 participants
n=99 Participants
|
234 participants
n=107 Participants
|
466 participants
n=206 Participants
|
|
Unanesthetized Schirmer Test Pre- Drop at Baseline (Day 1)
|
6.8 millimeter
STANDARD_DEVIATION 6.28 • n=99 Participants
|
6.4 millimeter
STANDARD_DEVIATION 5.47 • n=107 Participants
|
6.6 millimeter
STANDARD_DEVIATION 5.88 • n=206 Participants
|
|
Global SANDE Score at Baseline (Day 1)
|
73.4 millimeter
STANDARD_DEVIATION 11.99 • n=99 Participants
|
73.9 millimeter
STANDARD_DEVIATION 12.65 • n=107 Participants
|
73.6 millimeter
STANDARD_DEVIATION 12.32 • n=206 Participants
|
|
SANDE Frequency Score at Baseline (Day 1)
|
76.6 millimeter
STANDARD_DEVIATION 13.98 • n=99 Participants
|
76.8 millimeter
STANDARD_DEVIATION 14.13 • n=107 Participants
|
76.7 millimeter
STANDARD_DEVIATION 14.04 • n=206 Participants
|
|
SANDE Severity Score at Baseline (Day 1)
|
71.2 millimeter
STANDARD_DEVIATION 13.59 • n=99 Participants
|
71.8 millimeter
STANDARD_DEVIATION 13.94 • n=107 Participants
|
71.5 millimeter
STANDARD_DEVIATION 13.76 • n=206 Participants
|
|
Eye Dryness Score at Baseline (Day 1)
|
71.6 millimeter
STANDARD_DEVIATION 14.32 • n=99 Participants
|
70.6 millimeter
STANDARD_DEVIATION 17.69 • n=107 Participants
|
71.1 millimeter
STANDARD_DEVIATION 16.09 • n=206 Participants
|
|
Ocular Discomfort Score at Baseline (Day 1)
|
74.5 millimeter
STANDARD_DEVIATION 12.64 • n=99 Participants
|
73.2 millimeter
STANDARD_DEVIATION 13.34 • n=107 Participants
|
73.9 millimeter
STANDARD_DEVIATION 13.00 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) pre-drop; Day 14 post-dropPopulation: ITT population comprising all randomized subjects. This analysis uses multiple imputation methodology.
The Schirmer test measures tear production using a filter paper placed on the lower eyelid. The amount of wetting was recorded on a scale from 0 millimeters (mm) (no tear production) to 35 mm (maximum). The test was performed at Day 1 prior to drop exposure and at Day 14 following drop exposure. An increased score represents a positive outcome. One eye (study eye) contributed data to the analysis.
Outcome measures
| Measure |
0.003% AR-15512
n=232 eyes
0.003% AR-15512 ophthalmic solution, one drop in each eye twice a day for 90 days
|
AR-15512 Vehicle
n=234 eyes
AR-15512 vehicle ophthalmic solution, one drop in each eye twice a day for 90 days
|
|---|---|---|
|
Percentage of Subjects Who Achieved Equal to or Greater Than 10 Millimeter Increase From Pre-drop at Baseline to Post-drop on Day 14 in Study Eye Unanesthetized Schirmer Score
|
53.2 percentage of subjects
|
14.4 percentage of subjects
|
SECONDARY outcome
Timeframe: Baseline (Day 1); Day 28Population: ITT population comprising all randomized subjects. This analysis uses multiple imputation methodology.
The SANDE questionnaire assesses the frequency and severity of symptoms using 2 unique, 100 mm Visual Analog Scales to mark the frequency (0=rarely, 100=all the time) and severity (0=very mild, 100=very severe) of dry eye symptoms (prior to drop exposure). The 2 scores were multiplied and a square root was obtained for a resultant overall Global SANDE score of 0 to 100 where 0 represents no symptoms and 100 is maximum symptoms. A negative change indicates a better outcome. This was a subject based assessment (single score for both eyes).
Outcome measures
| Measure |
0.003% AR-15512
n=232 Participants
0.003% AR-15512 ophthalmic solution, one drop in each eye twice a day for 90 days
|
AR-15512 Vehicle
n=234 Participants
AR-15512 vehicle ophthalmic solution, one drop in each eye twice a day for 90 days
|
|---|---|---|
|
Least Squares Mean Change From Baseline in Global Symptom Assessment iN Dry Eye (SANDE) Score on Day 28
|
-22.3 millimeter
Standard Error 1.66
|
-19.1 millimeter
Standard Error 1.64
|
SECONDARY outcome
Timeframe: Baseline (Day 1) pre-drop; Day 14 post-dropPopulation: ITT population comprising all randomized subjects. This analysis uses multiple imputation methodology.
The Schirmer test measures tear production using a filter paper placed on the lower eyelid. The amount of wetting was recorded on a scale from 0 millimeters (mm) (no tear production) to 35 mm (maximum). The test was performed at Day 1 prior to drop exposure and at Day 14 following drop exposure. The Day 14 post-drop value was compared to the Day 1 pre-drop value. A positive change indicates a better outcome. One eye (study eye) contributed data to the analysis.
Outcome measures
| Measure |
0.003% AR-15512
n=232 eyes
0.003% AR-15512 ophthalmic solution, one drop in each eye twice a day for 90 days
|
AR-15512 Vehicle
n=234 eyes
AR-15512 vehicle ophthalmic solution, one drop in each eye twice a day for 90 days
|
|---|---|---|
|
Least Squares Mean Change From Pre-drop Baseline Unanesthetized Schirmer Score on Post-drop Day 14 (Study Eye)
|
10.9 millimeter
Standard Error 0.60
|
2.6 millimeter
Standard Error 0.59
|
SECONDARY outcome
Timeframe: Baseline (Day 1) pre-drop; Day 1 post-dropPopulation: ITT population comprising all randomized subjects. This analysis uses multiple imputation methodology.
The Schirmer test measures tear production using a filter paper placed on the lower eyelid. The amount of wetting was recorded on a scale from 0 millimeters (mm) (no tear production) to 35 mm (maximum). The test was performed at Day 1 prior to drop exposure and at each subsequent study visit. The study visit value was compared to the Day 1 pre-drop value. A positive change indicates a better outcome. One eye (study eye) contributed data to the analysis.
Outcome measures
| Measure |
0.003% AR-15512
n=232 eyes
0.003% AR-15512 ophthalmic solution, one drop in each eye twice a day for 90 days
|
AR-15512 Vehicle
n=234 eyes
AR-15512 vehicle ophthalmic solution, one drop in each eye twice a day for 90 days
|
|---|---|---|
|
Percentage of Subjects Who Achieved Equal to or Greater Than 10 Millimeter Increase From Pre-drop at Baseline to Post-drop on Day 1 in Study Eye Unanesthetized Schirmer Score
|
53.7 percentage of subjects
|
13.7 percentage of subjects
|
SECONDARY outcome
Timeframe: Baseline (Day 1) pre-drop; Day 1 post-dropPopulation: ITT population comprising all randomized subjects. This analysis uses multiple imputation methodology.
The Schirmer test measures tear production using a filter paper placed on the lower eyelid. The amount of wetting was recorded on a scale from 0 millimeters (mm) (no tear production) to 35 mm (maximum). The test was performed at Day 1 prior to drop exposure and at Day 1 following drop exposure. The Day 1 post-drop score was compared to the Day 1 pre-drop score. A positive change over time indicates a better outcome. One eye (study eye) contributed data to the analysis.
Outcome measures
| Measure |
0.003% AR-15512
n=232 eyes
0.003% AR-15512 ophthalmic solution, one drop in each eye twice a day for 90 days
|
AR-15512 Vehicle
n=234 eyes
AR-15512 vehicle ophthalmic solution, one drop in each eye twice a day for 90 days
|
|---|---|---|
|
Least Squares Mean Change From Pre-drop Baseline in Unanesthetized Schirmer Score on Post-drop Day 1 (Study Eye)
|
10.9 millimeter
Standard Deviation 0.53
|
3.3 millimeter
Standard Deviation 0.53
|
SECONDARY outcome
Timeframe: Baseline (Day 1) pre-drop; Day 90 post-dropPopulation: ITT population comprising all randomized subjects. This analysis uses multiple imputation methodology.
The Schirmer test measures tear production using a filter paper placed on the lower eyelid. The amount of wetting was recorded on a scale from 0 millimeters (mm) (no tear production) to 35 mm (maximum). The test was performed at Day 1 prior to drop exposure and at Day 90 following drop exposure. The Day 90 post-drop score was compared to the Day 1 pre-drop score. An increased score represents a positive outcome. One eye (study eye) contributed data to the analysis.
Outcome measures
| Measure |
0.003% AR-15512
n=232 eyes
0.003% AR-15512 ophthalmic solution, one drop in each eye twice a day for 90 days
|
AR-15512 Vehicle
n=234 eyes
AR-15512 vehicle ophthalmic solution, one drop in each eye twice a day for 90 days
|
|---|---|---|
|
Percentage of Subjects Who Achieved Equal to or Greater Than 10 Millimeter Increase From Pre-drop at Baseline to Post-drop on Day 90 in Study Eye Unanesthetized Schirmer Score
|
59.2 percentage of subjects
|
21.9 percentage of subjects
|
SECONDARY outcome
Timeframe: Baseline (Day 1) pre-drop; Day 90 post-dropPopulation: ITT population comprising all randomized subjects. This analysis uses multiple imputation methodology.
The Schirmer test measures tear production using a filter paper placed on the lower eyelid. The amount of wetting was recorded on a scale from 0 millimeters (mm) (no tear production) to 35 mm (maximum). The test was performed at Day 1 prior to drop exposure and at Day 90 following drop exposure. The Day 90 post-drop score was compared to the Day 1 pre-drop score. A positive change over time indicates a better outcome. One eye (study eye) contributed data to the analysis.
Outcome measures
| Measure |
0.003% AR-15512
n=232 eyes
0.003% AR-15512 ophthalmic solution, one drop in each eye twice a day for 90 days
|
AR-15512 Vehicle
n=234 eyes
AR-15512 vehicle ophthalmic solution, one drop in each eye twice a day for 90 days
|
|---|---|---|
|
Least Squares Mean Change From Pre-drop Baseline in Unanesthetized Schirmer Score on Post-drop Day 90 (Study Eye)
|
11.7 millimeter
Standard Error 0.63
|
3.7 millimeter
Standard Error 0.61
|
SECONDARY outcome
Timeframe: Baseline (Day 1); Day 90Population: ITT population comprising all randomized subjects. This analysis uses multiple imputation methodology.
The SANDE questionnaire assesses the frequency and severity of symptoms using 2 unique, 100 mm Visual Analog Scales to mark the frequency (0=rarely, 100=all the time) and severity (0=very mild, 100=very severe) of dry eye symptoms (prior to drop exposure). The 2 scores were multiplied and a square root was obtained for a resultant overall Global SANDE score of 0 to 100 where 0 represents no symptoms and 100 is maximum symptoms. A negative change indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes.
Outcome measures
| Measure |
0.003% AR-15512
n=232 Participants
0.003% AR-15512 ophthalmic solution, one drop in each eye twice a day for 90 days
|
AR-15512 Vehicle
n=234 Participants
AR-15512 vehicle ophthalmic solution, one drop in each eye twice a day for 90 days
|
|---|---|---|
|
Least Squares Mean Change From Baseline in Global SANDE Score on Day 90
|
-28.3 millimeter
Standard Error 1.92
|
-26.9 millimeter
Standard Error 1.88
|
SECONDARY outcome
Timeframe: Baseline (Day 1); Day 90Population: ITT population comprising all randomized subjects. This analysis uses multiple imputation methodology.
The SANDE questionnaire assesses the frequency of dry eye disease symptoms. Subjects used a 100 mm Visual Analog Scale (VAS) to mark the frequency of symptoms where 0=rarely and 100=all the time. A higher SANDE frequency score indicates greater symptoms of dryness and/or irritation. The questionnaire was completed at Day 1 and Day 90 prior to drop exposure (both visits). The Day 90 value was compared to the Day 1 value. A negative change indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes.
Outcome measures
| Measure |
0.003% AR-15512
n=232 Participants
0.003% AR-15512 ophthalmic solution, one drop in each eye twice a day for 90 days
|
AR-15512 Vehicle
n=234 Participants
AR-15512 vehicle ophthalmic solution, one drop in each eye twice a day for 90 days
|
|---|---|---|
|
Least Squares Mean Change From Baseline in SANDE Frequency Score on Day 90
|
-28.6 millimeter
Standard Error 2.03
|
-27.2 millimeter
Standard Error 2.00
|
SECONDARY outcome
Timeframe: Baseline (Day 1); Day 90Population: ITT population comprising all randomized subjects. This analysis uses multiple imputation methodology.
The SANDE questionnaire assesses the severity of dry eye disease symptoms. Subjects used a 100 mm Visual Analog Scale (VAS) to mark the severity of symptoms where 0=very mild and 100=very severe. A higher SANDE severity score indicates greater symptoms of dryness and/or irritation. The questionnaire was completed at Day 1 and Day 90 prior to drop exposure (both visits). The Day 90 value was compared to the Day 1 value. A negative change indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes.
Outcome measures
| Measure |
0.003% AR-15512
n=232 Participants
0.003% AR-15512 ophthalmic solution, one drop in each eye twice a day for 90 days
|
AR-15512 Vehicle
n=234 Participants
AR-15512 vehicle ophthalmic solution, one drop in each eye twice a day for 90 days
|
|---|---|---|
|
Least Squares Mean Change From Baseline in SANDE Severity Score on Day 90
|
-27.0 millimeter
Standard Error 1.95
|
-25.4 millimeter
Standard Error 1.91
|
SECONDARY outcome
Timeframe: Baseline (Day 1); Day 90Population: ITT population comprising all randomized subjects. This analysis uses multiple imputation methodology.
The subject used a 100 mm Visual Analog Scale (VAS) to mark their eye dryness, where 0=no eye dryness and 100=maximum eye dryness. Eye dryness was assessed at Day 1 and Day 90 prior to drop exposure (both visits). A higher eye dryness score indicates greater dryness. The Day 90 value was compared to the Day 1 value. A negative change indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes.
Outcome measures
| Measure |
0.003% AR-15512
n=232 Participants
0.003% AR-15512 ophthalmic solution, one drop in each eye twice a day for 90 days
|
AR-15512 Vehicle
n=234 Participants
AR-15512 vehicle ophthalmic solution, one drop in each eye twice a day for 90 days
|
|---|---|---|
|
Least Squares Mean Change From Baseline in Eye Dryness Score (EDS) on Day 90
|
-22.4 millimeter
Standard Error 1.98
|
-22.8 millimeter
Standard Error 1.97
|
SECONDARY outcome
Timeframe: Baseline (Day 1); Day 90Population: ITT population comprising all randomized subjects. This analysis uses multiple imputation methodology.
The subject used a 100 mm Visual Analog Scale (VAS) to mark their eye dryness, where 0=no ocular discomfort and 100 mm=maximum ocular discomfort. A higher ocular discomfort score indicates greater discomfort. Ocular discomfort was assessed at Day 1 and Day 90 prior to drop exposure (both visits). The Day 90 value was compared to the Day 1 value. A negative change indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes.
Outcome measures
| Measure |
0.003% AR-15512
n=232 Participants
0.003% AR-15512 ophthalmic solution, one drop in each eye twice a day for 90 days
|
AR-15512 Vehicle
n=234 Participants
AR-15512 vehicle ophthalmic solution, one drop in each eye twice a day for 90 days
|
|---|---|---|
|
Least Squares Mean Change From Baseline in Ocular Discomfort Score (ODS) on Day 90
|
-35.0 millimeter
Standard Error 2.14
|
-34.0 millimeter
Standard Error 2.14
|
Adverse Events
Pretreatment
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
0.003% AR-15512 Ocular
Serious events: 0 serious events
Other events: 118 other events
Deaths: 0 deaths
0.003% AR-15512 Nonocular
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
AR-15512 Vehicle Ocular
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
AR-15512 Vehicle Nonocular
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pretreatment
n=466 participants at risk
AEs reported in this group occurred prior to treatment with the study drug and include the 2-week vehicle run-in.
|
0.003% AR-15512 Ocular
n=232 participants at risk
AEs reported in this group occurred during the 0.003% AR-15512 ophthalmic solution treatment period.
|
0.003% AR-15512 Nonocular
n=232 participants at risk
AEs reported in this group occurred during the 0.003% AR-15512 ophthalmic solution treatment period.
|
AR-15512 Vehicle Ocular
n=234 participants at risk
AEs reported in this group occurred during the AR-15512 vehicle ophthalmic solution treatment period.
|
AR-15512 Vehicle Nonocular
n=234 participants at risk
AEs reported in this group occurred during the AR-15512 vehicle ophthalmic solution treatment period.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/466 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
—
0/0 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
0.43%
1/232 • Number of events 1 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
—
0/0 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
0.00%
0/234 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/466 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
—
0/0 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
0.43%
1/232 • Number of events 1 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
—
0/0 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
0.00%
0/234 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
|
Infections and infestations
COVID-19
|
0.00%
0/466 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
—
0/0 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
0.43%
1/232 • Number of events 1 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
—
0/0 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
0.00%
0/234 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/466 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
—
0/0 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
0.00%
0/232 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
—
0/0 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
0.43%
1/234 • Number of events 1 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/466 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
—
0/0 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
0.00%
0/232 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
—
0/0 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
0.43%
1/234 • Number of events 1 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/466 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
—
0/0 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
0.00%
0/232 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
—
0/0 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
0.43%
1/234 • Number of events 1 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/466 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
—
0/0 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
0.00%
0/232 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
—
0/0 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
0.43%
1/234 • Number of events 1 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/466 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
—
0/0 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
0.00%
0/232 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
—
0/0 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
0.43%
1/234 • Number of events 1 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/466 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
—
0/0 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
0.00%
0/232 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
—
0/0 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
0.43%
1/234 • Number of events 1 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
Other adverse events
| Measure |
Pretreatment
n=466 participants at risk
AEs reported in this group occurred prior to treatment with the study drug and include the 2-week vehicle run-in.
|
0.003% AR-15512 Ocular
n=232 participants at risk
AEs reported in this group occurred during the 0.003% AR-15512 ophthalmic solution treatment period.
|
0.003% AR-15512 Nonocular
n=232 participants at risk
AEs reported in this group occurred during the 0.003% AR-15512 ophthalmic solution treatment period.
|
AR-15512 Vehicle Ocular
n=234 participants at risk
AEs reported in this group occurred during the AR-15512 vehicle ophthalmic solution treatment period.
|
AR-15512 Vehicle Nonocular
n=234 participants at risk
AEs reported in this group occurred during the AR-15512 vehicle ophthalmic solution treatment period.
|
|---|---|---|---|---|---|
|
General disorders
Instillation site pain
|
1.1%
5/466 • Number of events 5 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
50.9%
118/232 • Number of events 124 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
—
0/0 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
|
3.0%
7/234 • Number of events 7 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
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0/0 • An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
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Additional Information
Scientific Advisor, Clinical Research and Development
Alcon Research, LLC
Phone: 1-888-451-3937
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER