Trial Outcomes & Findings for Study to Evaluate the Efficacy of Lagricel® Ofteno PF Compared to Thealoz® Duo After Photorefractive Keratectomy (NCT NCT04704518)
NCT ID: NCT04704518
Last Updated: 2026-04-07
Results Overview
Corneal re-epithelialization will be evaluated through direct observation and photographic recording after application of fluorescein stain. After instillation of a drop of topical anesthetic (tetracaine 0.5%) a fluorescein strip will be applied on the inferior cul de sac while the patient looks upward. Using a slit lamp with magnification of 6x and 16x photographs (at least 6 images for each magnification) will be obtained.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
96 participants
Primary outcome timeframe
Days: 1 (baseline visit), 2 (±1) (first follow-up visit), 3 (±1) (second follow-up visit), 7 (±1) (third follow-up visit)
Results posted on
2026-04-07
Participant Flow
Participant milestones
| Measure |
Group 1; Lagricel® Ofteno PF
Lagricel® Ofteno PF, multidose presentation (sodium hyaluronate 0.4%) Ophthalmic Solution. One drop QID, both eyes (OU) for 14 days.
Sodium Hyaluronate Ophthalmic 0.4%: Topical ophthalmic administration of one drop of Lagricel® Ofteno PF QID.
|
Group 2; Thealoz® Duo
Thealoz® Duo, (trehalose 3%/sodium hyaluronate 0.15%). Ophthalmic Solution. One drop QID, both eyes (OU) for 14 days.
Trehalose 3% / Sodium Hyaluronate Ophthalmic 0.15%: Topical ophthalmic administration of one drop of Thealoz® Duo QID.
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
48
|
|
Overall Study
COMPLETED
|
45
|
43
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
Group 1; Lagricel® Ofteno PF
Lagricel® Ofteno PF, multidose presentation (sodium hyaluronate 0.4%) Ophthalmic Solution. One drop QID, both eyes (OU) for 14 days.
Sodium Hyaluronate Ophthalmic 0.4%: Topical ophthalmic administration of one drop of Lagricel® Ofteno PF QID.
|
Group 2; Thealoz® Duo
Thealoz® Duo, (trehalose 3%/sodium hyaluronate 0.15%). Ophthalmic Solution. One drop QID, both eyes (OU) for 14 days.
Trehalose 3% / Sodium Hyaluronate Ophthalmic 0.15%: Topical ophthalmic administration of one drop of Thealoz® Duo QID.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
3
|
|
Overall Study
Adherence below protocol-stipulated limit (70%)
|
2
|
2
|
Baseline Characteristics
Study to Evaluate the Efficacy of Lagricel® Ofteno PF Compared to Thealoz® Duo After Photorefractive Keratectomy
Baseline characteristics by cohort
| Measure |
Group 1; Lagricel® Ofteno PF
n=48 Participants
Lagricel® Ofteno PF, multidose presentation (sodium hyaluronate 0.4%) Ophthalmic Solution. One drop QID, both eyes (OU) for 14 days.
Sodium Hyaluronate Ophthalmic 0.4%: Topical ophthalmic administration of one drop of Lagricel® Ofteno PF QID.
|
Group 2; Thealoz® Duo
n=47 Participants
Thealoz® Duo, (trehalose 3%/sodium hyaluronate 0.15%). Ophthalmic Solution. One drop QID, both eyes (OU) for 14 days.
Trehalose 3% / Sodium Hyaluronate Ophthalmic 0.15%: Topical ophthalmic administration of one drop of Thealoz® Duo QID.
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race/Ethnicity, Customized
Hispanic or Latin
|
48 Participants
n=527 Participants
|
47 Participants
n=527 Participants
|
95 Participants
n=1054 Participants
|
|
Age, Continuous
|
29.50 years
STANDARD_DEVIATION 7.01 • n=527 Participants
|
26.74 years
STANDARD_DEVIATION 5.75 • n=527 Participants
|
28.14 years
STANDARD_DEVIATION 6.53 • n=1054 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=527 Participants
|
29 Participants
n=527 Participants
|
61 Participants
n=1054 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=527 Participants
|
18 Participants
n=527 Participants
|
34 Participants
n=1054 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latin
|
0 Participants
n=527 Participants
|
0 Participants
n=527 Participants
|
0 Participants
n=1054 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=527 Participants
|
0 Participants
n=527 Participants
|
0 Participants
n=1054 Participants
|
|
Region of Enrollment
Mexico
|
48 Participants
n=527 Participants
|
47 Participants
n=527 Participants
|
95 Participants
n=1054 Participants
|
|
Corneal epithelial defects
|
22 Participants
n=527 Participants
|
21 Participants
n=527 Participants
|
43 Participants
n=1054 Participants
|
PRIMARY outcome
Timeframe: Days: 1 (baseline visit), 2 (±1) (first follow-up visit), 3 (±1) (second follow-up visit), 7 (±1) (third follow-up visit)Population: The evaluated population for this outcome measure was the PP population (subjects who finished the study without presenting any mayor deviations to protocol, including adherence to treatment)
Corneal re-epithelialization will be evaluated through direct observation and photographic recording after application of fluorescein stain. After instillation of a drop of topical anesthetic (tetracaine 0.5%) a fluorescein strip will be applied on the inferior cul de sac while the patient looks upward. Using a slit lamp with magnification of 6x and 16x photographs (at least 6 images for each magnification) will be obtained.
Outcome measures
| Measure |
Group 1; Lagricel® Ofteno PF
n=45 Participants
Lagricel® Ofteno PF, multidose presentation (sodium hyaluronate 0.4%) Ophthalmic Solution. One drop QID, both eyes (OU) for 14 days.
Sodium Hyaluronate Ophthalmic 0.4%: Topical ophthalmic administration of one drop of Lagricel® Ofteno PF QID.
|
Group 2; Thealoz® Duo
n=43 Participants
Thealoz® Duo, (trehalose 3%/sodium hyaluronate 0.15%). Ophthalmic Solution. One drop QID, both eyes (OU) for 14 days.
Trehalose 3% / Sodium Hyaluronate Ophthalmic 0.15%: Topical ophthalmic administration of one drop of Thealoz® Duo QID.
|
|---|---|---|
|
Changes in Corneal Re-epithelialization (Time)
|
5.39 days
Standard Deviation 3.78
|
5.34 days
Standard Deviation 3.46
|
PRIMARY outcome
Timeframe: Days: 1 (baseline visit: BV), 2 (±1) (first follow-up visit: V1), 3 (±1) (second follow-up visit: V2), 7 (±1) (third follow-up visit: V3) and 15 (±1) (final visit: FV)Population: This outcome measure considered the Intention-To-Treat (ITT) population, all participants who were randomized and exposed to treatment, regardless of whether they finished the study.
(VA) is a test of visual function. It will be evaluated with the Snellen chart. The Snellen chart is the standard tool used to evaluate visual acuity. It was located in a place with adequate lighting, natural or artificial and at a distance of 3 meters from the subject to be evaluated. The contralateral eye to which it will be evaluated is covered, then the examiner detects until the line can clearly see the letters given he or she a score, the normal score for a VA is 20/20.This score can be expressed in fraction (i.e. 20/20) decimal (i.e. 1.0), or LogMAR (i.e. 0) formats. In this study, VA is expressed in decimal format. In decimal format, a lower number is a worse outcome.
Outcome measures
| Measure |
Group 1; Lagricel® Ofteno PF
n=48 Participants
Lagricel® Ofteno PF, multidose presentation (sodium hyaluronate 0.4%) Ophthalmic Solution. One drop QID, both eyes (OU) for 14 days.
Sodium Hyaluronate Ophthalmic 0.4%: Topical ophthalmic administration of one drop of Lagricel® Ofteno PF QID.
|
Group 2; Thealoz® Duo
n=47 Participants
Thealoz® Duo, (trehalose 3%/sodium hyaluronate 0.15%). Ophthalmic Solution. One drop QID, both eyes (OU) for 14 days.
Trehalose 3% / Sodium Hyaluronate Ophthalmic 0.15%: Topical ophthalmic administration of one drop of Thealoz® Duo QID.
|
|---|---|---|
|
Best Corrected Visual Acuity (BCVA)
BV
|
0.58 decimal score
Standard Deviation 0.16
|
0.61 decimal score
Standard Deviation 0.20
|
|
Best Corrected Visual Acuity (BCVA)
V1
|
0.53 decimal score
Standard Deviation 0.16
|
0.55 decimal score
Standard Deviation 0.15
|
|
Best Corrected Visual Acuity (BCVA)
V2
|
0.62 decimal score
Standard Deviation 0.18
|
0.65 decimal score
Standard Deviation 0.20
|
|
Best Corrected Visual Acuity (BCVA)
V3
|
0.80 decimal score
Standard Deviation 0.18
|
0.76 decimal score
Standard Deviation 0.22
|
|
Best Corrected Visual Acuity (BCVA)
FV
|
0.88 decimal score
Standard Deviation 0.18
|
0.86 decimal score
Standard Deviation 0.19
|
SECONDARY outcome
Timeframe: Days: 7 (±1) (third follow-up visit: V3) and 15 (±1) (final visit: FV)Population: The evaluated population for this outcome measure was the PP population (subjects who finished the study without presenting any mayor deviations to protocol)
Ocular Comfort Index (OCI) Questionnaire will be used for evaluation of tolerability through incidence and severity of dry eye symptoms in a scale from 0 to 100. Greater scores mean a worse outcome.
Outcome measures
| Measure |
Group 1; Lagricel® Ofteno PF
n=45 Participants
Lagricel® Ofteno PF, multidose presentation (sodium hyaluronate 0.4%) Ophthalmic Solution. One drop QID, both eyes (OU) for 14 days.
Sodium Hyaluronate Ophthalmic 0.4%: Topical ophthalmic administration of one drop of Lagricel® Ofteno PF QID.
|
Group 2; Thealoz® Duo
n=43 Participants
Thealoz® Duo, (trehalose 3%/sodium hyaluronate 0.15%). Ophthalmic Solution. One drop QID, both eyes (OU) for 14 days.
Trehalose 3% / Sodium Hyaluronate Ophthalmic 0.15%: Topical ophthalmic administration of one drop of Thealoz® Duo QID.
|
|---|---|---|
|
Changes in Ocular Comfort Index
FV
|
20.32 score on a scale
Standard Deviation 11.78
|
19.51 score on a scale
Standard Deviation 12.68
|
|
Changes in Ocular Comfort Index
V3
|
25.20 score on a scale
Standard Deviation 11.88
|
25.25 score on a scale
Standard Deviation 11.36
|
SECONDARY outcome
Timeframe: Days: 1 (baseline visit: BV), 2 (±1) (first follow-up visit: V1), 3 (±1) (second follow-up visit: V2), 7 (±1) (third follow-up visit: V3) and 15 (±1) (final visit: FV)Population: The population evaluated for this outcome measure was the per-protocol population (PP, subjects who completed the study without significant deviations from the protocol).
Through a questionnaire, patients will be directly questioned about presence and severity of pain and associated symptoms. The scale will be as follows for severity: absent (0), very mild (1), mild (2), moderate (3) and severe (4)
Outcome measures
| Measure |
Group 1; Lagricel® Ofteno PF
n=45 Participants
Lagricel® Ofteno PF, multidose presentation (sodium hyaluronate 0.4%) Ophthalmic Solution. One drop QID, both eyes (OU) for 14 days.
Sodium Hyaluronate Ophthalmic 0.4%: Topical ophthalmic administration of one drop of Lagricel® Ofteno PF QID.
|
Group 2; Thealoz® Duo
n=43 Participants
Thealoz® Duo, (trehalose 3%/sodium hyaluronate 0.15%). Ophthalmic Solution. One drop QID, both eyes (OU) for 14 days.
Trehalose 3% / Sodium Hyaluronate Ophthalmic 0.15%: Topical ophthalmic administration of one drop of Thealoz® Duo QID.
|
|---|---|---|
|
Pain Perception
BV Pain Perception · No pain
|
3 Participants
|
3 Participants
|
|
Pain Perception
BV Pain Perception · Very mild pain
|
4 Participants
|
7 Participants
|
|
Pain Perception
BV Pain Perception · Mild pain
|
8 Participants
|
11 Participants
|
|
Pain Perception
BV Pain Perception · Moderate mild
|
23 Participants
|
18 Participants
|
|
Pain Perception
BV Pain Perception · Severe pain
|
7 Participants
|
4 Participants
|
|
Pain Perception
V1 Pain Perception · No pain
|
7 Participants
|
6 Participants
|
|
Pain Perception
V1 Pain Perception · Very mild pain
|
9 Participants
|
6 Participants
|
|
Pain Perception
V1 Pain Perception · Mild pain
|
13 Participants
|
17 Participants
|
|
Pain Perception
V1 Pain Perception · Moderate mild
|
15 Participants
|
12 Participants
|
|
Pain Perception
V1 Pain Perception · Severe pain
|
1 Participants
|
2 Participants
|
|
Pain Perception
V2 Pain Perception · No pain
|
23 Participants
|
21 Participants
|
|
Pain Perception
V2 Pain Perception · Very mild pain
|
12 Participants
|
9 Participants
|
|
Pain Perception
V2 Pain Perception · Mild pain
|
8 Participants
|
12 Participants
|
|
Pain Perception
V2 Pain Perception · Moderate mild
|
1 Participants
|
0 Participants
|
|
Pain Perception
V2 Pain Perception · Severe pain
|
1 Participants
|
1 Participants
|
|
Pain Perception
V3 Pain Perception · No pain
|
38 Participants
|
36 Participants
|
|
Pain Perception
V3 Pain Perception · Very mild pain
|
7 Participants
|
4 Participants
|
|
Pain Perception
V3 Pain Perception · Mild pain
|
0 Participants
|
1 Participants
|
|
Pain Perception
V3 Pain Perception · Moderate mild
|
0 Participants
|
2 Participants
|
|
Pain Perception
V3 Pain Perception · Severe pain
|
0 Participants
|
0 Participants
|
|
Pain Perception
FV Pain Perception · No pain
|
44 Participants
|
41 Participants
|
|
Pain Perception
FV Pain Perception · Very mild pain
|
0 Participants
|
1 Participants
|
|
Pain Perception
FV Pain Perception · Mild pain
|
1 Participants
|
0 Participants
|
|
Pain Perception
FV Pain Perception · Moderate mild
|
0 Participants
|
1 Participants
|
|
Pain Perception
FV Pain Perception · Severe pain
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days: 1 (baseline visit: BV), 2 (±1) (first follow-up visit: V1), 3 (±1) (second follow-up visit: V2), 7 (±1) (third follow-up visit: V3) and 15 (±1) (final visit: FV)Population: The population evaluated for this outcome measure was the per-protocol population (PP, subjects who completed the study without significant deviations from the protocol).
Through a questionnaire, patients will be directly questioned about presence, severity and frequency of pain and associated symptoms. The scale will be as follows for frequency: never (0), almost never (1), 50% of the time (2), almost all the time (3) and all the time (4).
Outcome measures
| Measure |
Group 1; Lagricel® Ofteno PF
n=45 Participants
Lagricel® Ofteno PF, multidose presentation (sodium hyaluronate 0.4%) Ophthalmic Solution. One drop QID, both eyes (OU) for 14 days.
Sodium Hyaluronate Ophthalmic 0.4%: Topical ophthalmic administration of one drop of Lagricel® Ofteno PF QID.
|
Group 2; Thealoz® Duo
n=43 Participants
Thealoz® Duo, (trehalose 3%/sodium hyaluronate 0.15%). Ophthalmic Solution. One drop QID, both eyes (OU) for 14 days.
Trehalose 3% / Sodium Hyaluronate Ophthalmic 0.15%: Topical ophthalmic administration of one drop of Thealoz® Duo QID.
|
|---|---|---|
|
Frequency of Pain Perception
V1 Frequency pain perception · 50% of the time
|
15 Participants
|
16 Participants
|
|
Frequency of Pain Perception
V1 Frequency pain perception · Almost all the time
|
9 Participants
|
7 Participants
|
|
Frequency of Pain Perception
V1 Frequency pain perception · At all times
|
0 Participants
|
3 Participants
|
|
Frequency of Pain Perception
V2 Frequency pain perception · At no time
|
23 Participants
|
21 Participants
|
|
Frequency of Pain Perception
V2 Frequency pain perception · Almost never
|
18 Participants
|
17 Participants
|
|
Frequency of Pain Perception
V3 Frequency pain perception · At all times
|
0 Participants
|
1 Participants
|
|
Frequency of Pain Perception
FV Frequency pain perception · At no time
|
44 Participants
|
41 Participants
|
|
Frequency of Pain Perception
BV Frequency pain perception · At no time
|
3 Participants
|
3 Participants
|
|
Frequency of Pain Perception
BV Frequency pain perception · Almost never
|
12 Participants
|
9 Participants
|
|
Frequency of Pain Perception
BV Frequency pain perception · 50% of the time
|
9 Participants
|
10 Participants
|
|
Frequency of Pain Perception
BV Frequency pain perception · Almost all the time
|
15 Participants
|
16 Participants
|
|
Frequency of Pain Perception
BV Frequency pain perception · At all times
|
6 Participants
|
5 Participants
|
|
Frequency of Pain Perception
V1 Frequency pain perception · At no time
|
7 Participants
|
6 Participants
|
|
Frequency of Pain Perception
V1 Frequency pain perception · Almost never
|
14 Participants
|
11 Participants
|
|
Frequency of Pain Perception
V2 Frequency pain perception · 50% of the time
|
3 Participants
|
2 Participants
|
|
Frequency of Pain Perception
V2 Frequency pain perception · Almost all the time
|
1 Participants
|
1 Participants
|
|
Frequency of Pain Perception
V2 Frequency pain perception · At all times
|
0 Participants
|
2 Participants
|
|
Frequency of Pain Perception
V3 Frequency pain perception · At no time
|
38 Participants
|
36 Participants
|
|
Frequency of Pain Perception
V3 Frequency pain perception · Almost never
|
7 Participants
|
6 Participants
|
|
Frequency of Pain Perception
V3 Frequency pain perception · 50% of the time
|
0 Participants
|
0 Participants
|
|
Frequency of Pain Perception
V3 Frequency pain perception · Almost all the time
|
0 Participants
|
0 Participants
|
|
Frequency of Pain Perception
FV Frequency pain perception · Almost never
|
1 Participants
|
1 Participants
|
|
Frequency of Pain Perception
FV Frequency pain perception · 50% of the time
|
0 Participants
|
0 Participants
|
|
Frequency of Pain Perception
FV Frequency pain perception · Almost all the time
|
0 Participants
|
0 Participants
|
|
Frequency of Pain Perception
FV Frequency pain perception · At all times
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day: 17 (± 1) (safety call)Population: This result was described using the intention-to-treat (ITT) population.
The number of unexpected adverse events related to the investigational product that were recorded in each treatment group is described
Outcome measures
| Measure |
Group 1; Lagricel® Ofteno PF
n=48 Participants
Lagricel® Ofteno PF, multidose presentation (sodium hyaluronate 0.4%) Ophthalmic Solution. One drop QID, both eyes (OU) for 14 days.
Sodium Hyaluronate Ophthalmic 0.4%: Topical ophthalmic administration of one drop of Lagricel® Ofteno PF QID.
|
Group 2; Thealoz® Duo
n=47 Participants
Thealoz® Duo, (trehalose 3%/sodium hyaluronate 0.15%). Ophthalmic Solution. One drop QID, both eyes (OU) for 14 days.
Trehalose 3% / Sodium Hyaluronate Ophthalmic 0.15%: Topical ophthalmic administration of one drop of Thealoz® Duo QID.
|
|---|---|---|
|
Unexpected Adverse Events (AEs) Related to the Investigational Product
expected related adverse events
|
17 number of events
|
12 number of events
|
|
Unexpected Adverse Events (AEs) Related to the Investigational Product
Unexpected adverse events related to
|
2 number of events
|
1 number of events
|
Adverse Events
Group 1; Lagricel® Ofteno PF
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Group 2; Thealoz® Duo
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1; Lagricel® Ofteno PF
n=48 participants at risk
Lagricel® Ofteno PF, multidose presentation (sodium hyaluronate 0.4%) Ophthalmic Solution. One drop QID, both eyes (OU) for 14 days.
Sodium Hyaluronate Ophthalmic 0.4%: Topical ophthalmic administration of one drop of Lagricel® Ofteno PF QID.
|
Group 2; Thealoz® Duo
n=47 participants at risk
Thealoz® Duo, (trehalose 3%/sodium hyaluronate 0.15%). Ophthalmic Solution. One drop QID, both eyes (OU) for 14 days.
Trehalose 3% / Sodium Hyaluronate Ophthalmic 0.15%: Topical ophthalmic administration of one drop of Thealoz® Duo QID.
|
|---|---|---|
|
Eye disorders
Decreased visual acuity
|
8.3%
4/48 • Number of events 4 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
10.6%
5/47 • Number of events 5 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
Alteración corneal
|
2.1%
1/48 • Number of events 1 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
0.00%
0/47 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Nervous system disorders
Headache
|
2.1%
1/48 • Number of events 1 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
4.3%
2/47 • Number of events 2 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
Corneal epithelial defect
|
45.8%
22/48 • Number of events 22 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
44.7%
21/47 • Number of events 21 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
Eye pain
|
2.1%
1/48 • Number of events 1 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
0.00%
0/47 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
Eyelid edema
|
4.2%
2/48 • Number of events 2 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
6.4%
3/47 • Number of events 3 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
Photophobia
|
10.4%
5/48 • Number of events 5 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
4.3%
2/47 • Number of events 2 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
Ocular hypertension
|
2.1%
1/48 • Number of events 1 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
0.00%
0/47 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
Irritation in the instillation area
|
18.8%
9/48 • Number of events 9 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
10.6%
5/47 • Number of events 5 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
Eye irritation
|
12.5%
6/48 • Number of events 6 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
19.1%
9/47 • Number of events 9 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
Tearing
|
6.2%
3/48 • Number of events 3 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
2.1%
1/47 • Number of events 1 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
Eye discomfort
|
2.1%
1/48 • Number of events 1 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
0.00%
0/47 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
Dry eye
|
6.2%
3/48 • Number of events 3 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
14.9%
7/47 • Number of events 7 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
Corneal opacity
|
2.1%
1/48 • Number of events 1 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
0.00%
0/47 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
Ocular paresthesia
|
2.1%
1/48 • Number of events 1 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
0.00%
0/47 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
Itchy eye
|
4.2%
2/48 • Number of events 2 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
2.1%
1/47 • Number of events 1 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
Itching in the instillation area
|
4.2%
2/48 • Number of events 2 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
2.1%
1/47 • Number of events 1 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
Abnormal sensation in the eye
|
8.3%
4/48 • Number of events 4 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
2.1%
1/47 • Number of events 1 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
Foreign body sensation in the instillation area
|
2.1%
1/48 • Number of events 1 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
2.1%
1/47 • Number of events 1 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
Foreign body sensation in the eyes
|
18.8%
9/48 • Number of events 9 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
12.8%
6/47 • Number of events 6 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
Blurred vision
|
10.4%
5/48 • Number of events 5 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
2.1%
1/47 • Number of events 1 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
Asthenopia
|
0.00%
0/48 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
2.1%
1/47 • Number of events 1 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
Dyspepsia
|
0.00%
0/48 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
2.1%
1/47 • Number of events 1 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
Conjunctival hyperemia
|
0.00%
0/48 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
2.1%
1/47 • Number of events 1 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
Eye inflammation
|
0.00%
0/48 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
2.1%
1/47 • Number of events 1 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Eye disorders
Punctate keratitis
|
0.00%
0/48 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
6.4%
3/47 • Number of events 3 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Gastrointestinal disorders
Pain in the upper abdomen
|
0.00%
0/48 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
2.1%
1/47 • Number of events 1 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Gastrointestinal disorders
Oropharyngeal pain
|
0.00%
0/48 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
2.1%
1/47 • Number of events 1 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
0.00%
0/48 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
2.1%
1/47 • Number of events 1 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/48 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
2.1%
1/47 • Number of events 1 • From day 1 (basal visit) to the safety call on day 17 (+1)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place