Trial Outcomes & Findings for A Study Designed to Evaluate Tear Production (NCT NCT06544707)
NCT ID: NCT06544707
Last Updated: 2026-02-10
Results Overview
TMH (the distance between the line of reflection along the top of the tear prism to the edge of the central lower eyelid) was measured pre-instillation and post-instillation in micrometers using optical coherence tomography (OCT), a non-invasive imaging test that uses light waves to take cross-section pictures of the eye. A normal TMH range falls between 200 and 400 micrometers. Measurements below this range may indicate dry eye disease. A positive change value indicates an improvement. One eye (study eye, defined as the left eye) contributed data to the analysis.
COMPLETED
PHASE3
81 participants
Day 1, Minute 0 pre-instillation (Baseline); Day 1, Minute 3 post-instillation
2026-02-10
Participant Flow
Participants were recruited from 1 investigative site located in the United States.
This reporting group includes all subjects treated with 0.003% AR-15512 (81).
Participant milestones
| Measure |
0.003% AR-15512 - Stage 1
One drop of 0.003% AR-15512 ophthalmic solution in each eye in a staggered cadence (left eye followed by dosing of the right eye, separated by approximately 2-4 hours)
|
0.003% AR-15512 - Stage 2
One drop of 0.003% AR-15512 ophthalmic solution in each eye in a staggered cadence (left eye followed by dosing of the right eye, separated by approximately 2-4 hours)
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
41
|
|
Overall Study
COMPLETED
|
40
|
41
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study Designed to Evaluate Tear Production
Baseline characteristics by cohort
| Measure |
0.003% AR-15512 - Stage 1
n=40 Participants
One drop of 0.003% AR-15512 ophthalmic solution in each eye in a staggered cadence (left eye followed by dosing of the right eye, separated by approximately 2-4 hours)
|
0.003% AR-15512 - Stage 2
n=41 Participants
One drop of 0.003% AR-15512 ophthalmic solution in each eye in a staggered cadence (left eye followed by dosing of the right eye, separated by approximately 2-4 hours)
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Male
|
12 Participants
n=41 Participants
|
12 Participants
n=1581 Participants
|
24 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
10 Participants
n=41 Participants
|
11 Participants
n=1581 Participants
|
21 Participants
n=4626 Participants
|
|
Age, Continuous
|
60.4 years
STANDARD_DEVIATION 13.83 • n=41 Participants
|
62.5 years
STANDARD_DEVIATION 14.80 • n=1581 Participants
|
61.5 years
STANDARD_DEVIATION 14.28 • n=4626 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=41 Participants
|
29 Participants
n=1581 Participants
|
57 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
30 Participants
n=41 Participants
|
30 Participants
n=1581 Participants
|
60 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
2 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
Asian
|
9 Participants
n=41 Participants
|
9 Participants
n=1581 Participants
|
18 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
White
|
31 Participants
n=41 Participants
|
28 Participants
n=1581 Participants
|
59 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
Multi-Racial
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=41 Participants
|
41 participants
n=1581 Participants
|
81 participants
n=4626 Participants
|
PRIMARY outcome
Timeframe: Day 1, Minute 0 pre-instillation (Baseline); Day 1, Minute 3 post-instillationPopulation: Full Analysis Set
TMH (the distance between the line of reflection along the top of the tear prism to the edge of the central lower eyelid) was measured pre-instillation and post-instillation in micrometers using optical coherence tomography (OCT), a non-invasive imaging test that uses light waves to take cross-section pictures of the eye. A normal TMH range falls between 200 and 400 micrometers. Measurements below this range may indicate dry eye disease. A positive change value indicates an improvement. One eye (study eye, defined as the left eye) contributed data to the analysis.
Outcome measures
| Measure |
0.003% AR-15512 - Stage 1
n=40 eyes
One drop of 0.003% AR-15512 ophthalmic solution in each eye in a staggered cadence (left eye followed by dosing of the right eye, separated by approximately 2-4 hours)
|
|---|---|
|
Mean Change From Baseline in Tear Meniscus Height (TMH) at Minute 3 - Stage 1
|
519.65 micrometers
Standard Deviation 515.561
|
PRIMARY outcome
Timeframe: Day 1, Minute 0 pre-instillation (Baseline); Day 1, Minute 3 post-instillationPopulation: Full Analysis Set
TMH (the distance between the line of reflection along the top of the tear prism to the edge of the central lower eyelid) was measured pre-instillation and post-instillation in micrometers using optical coherence tomography (OCT), a non-invasive imaging test that uses light waves to take cross-section pictures of the eye. A normal TMH range falls between 200 and 400 micrometers. Measurements below this range may indicate dry eye disease. A positive change value indicates an improvement. One eye (study eye, defined as the left eye) contributed data to the analysis.
Outcome measures
| Measure |
0.003% AR-15512 - Stage 1
n=41 eyes
One drop of 0.003% AR-15512 ophthalmic solution in each eye in a staggered cadence (left eye followed by dosing of the right eye, separated by approximately 2-4 hours)
|
|---|---|
|
Mean Change From Baseline in Tear Meniscus Height (TMH) at Minute 3 - Stage 2
|
503.80 micrometers
Standard Deviation 559.552
|
Adverse Events
Pretreatment
0.003% AR-15512 - Stage 1
0.003% AR-15512 - Stage 2
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pretreatment
n=81 participants at risk
AEs occurring from time of consent until initiation of treatment with 0.003% AR-15512
|
0.003% AR-15512 - Stage 1
n=40 participants at risk
One drop of 0.003% AR-15512 ophthalmic solution in each eye in a staggered cadence (left eye followed by dosing of the right eye, separated by approximately 2-4 hours)
|
0.003% AR-15512 - Stage 2
n=41 participants at risk
One drop of 0.003% AR-15512 ophthalmic solution in each eye in a staggered cadence (left eye followed by dosing of the right eye, separated by approximately 2-4 hours)
|
|---|---|---|---|
|
General disorders
Instillation site irritation
|
0.00%
0/81 • Adverse Events (AEs) were collected from time of consent until study exit, approximately 1 day.
An AE was defined as any untoward medical occurrence associated with the administration of the study intervention in humans, whether or not considered to be related to the study intervention. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. The safety analysis set included all subjects who have received at least one dose of 0.003% AR-15512.
|
47.5%
19/40 • Number of events 19 • Adverse Events (AEs) were collected from time of consent until study exit, approximately 1 day.
An AE was defined as any untoward medical occurrence associated with the administration of the study intervention in humans, whether or not considered to be related to the study intervention. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. The safety analysis set included all subjects who have received at least one dose of 0.003% AR-15512.
|
39.0%
16/41 • Number of events 16 • Adverse Events (AEs) were collected from time of consent until study exit, approximately 1 day.
An AE was defined as any untoward medical occurrence associated with the administration of the study intervention in humans, whether or not considered to be related to the study intervention. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. The safety analysis set included all subjects who have received at least one dose of 0.003% AR-15512.
|
Additional Information
Scientific Advisor, Clinical Research and Development
Alcon Research, LLC
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