Trial Outcomes & Findings for A Study to Evaluate 0.003% AR-15512 Safety and Drop Attributes (NCT NCT06660290)
NCT ID: NCT06660290
Last Updated: 2026-03-17
Results Overview
Treatment-emergent adverse events (TEAEs) were defined as any event that occurred or worsened on or after the day that study intervention was initiated. No hypothesis testing was prespecified for this endpoint.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
55 participants
Primary outcome timeframe
Up to Day 1 post drop instillation
Results posted on
2026-03-17
Participant Flow
Participants were recruited from 6 investigative sites located in the United States.
This reporting group includes all randomized subjects (55).
Participant milestones
| Measure |
Artificial Tears First, Then 512-RT, 512-COLD, 512-RT-EC, 512-COLD-EC
Each instillation consisted of one drop in one eye only starting with artificial tears in the right eye, then alternating the eyes thereafter. Protocol-specified wait periods separated each instillation.
|
Artificial Tears, Then 512-RT-EC, 512-RT, 512-COLD-EC, 512-COLD
Each instillation consisted of one drop in one eye only starting with artificial tears in the right eye, then alternating the eyes thereafter. Protocol-specified wait periods separated each instillation.
|
Artificial Tears, Then 512-COLD, 512-COLD-EC, 512-RT, 512-RT-EC
Each instillation consisted of one drop in one eye only starting with artificial tears in the right eye, then alternating the eyes thereafter. Protocol-specified wait periods separated each instillation.
|
Artificial Tears, Then 512-COLD-EC, 512-RT-EC, 512-COLD, 512-RT
Each instillation consisted of one drop in one eye only starting with artificial tears in the right eye, then alternating the eyes thereafter. Protocol-specified wait periods separated each instillation.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
13
|
14
|
14
|
|
Overall Study
COMPLETED
|
14
|
13
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate 0.003% AR-15512 Safety and Drop Attributes
Baseline characteristics by cohort
| Measure |
Artificial Tears First, Then 512-RT, 512-COLD, 512-RT-EC, 512-COLD-EC
n=14 Participants
Each instillation consisted of one drop in one eye only starting with artificial tears in the right eye, then alternating the eyes thereafter. Protocol-specified wait periods separated each instillation.
|
Artificial Tears, Then 512-RT-EC, 512-RT, 512-COLD-EC, 512-COLD
n=13 Participants
Each instillation consisted of one drop in one eye only starting with artificial tears in the right eye, then alternating the eyes thereafter. Protocol-specified wait periods separated each instillation.
|
Artificial Tears, Then 512-COLD, 512-COLD-EC, 512-RT, 512-RT-EC
n=14 Participants
Each instillation consisted of one drop in one eye only starting with artificial tears in the right eye, then alternating the eyes thereafter. Protocol-specified wait periods separated each instillation.
|
Artificial Tears, Then 512-COLD-EC, 512-RT-EC, 512-COLD, 512-RT
n=14 Participants
Each instillation consisted of one drop in one eye only starting with artificial tears in the right eye, then alternating the eyes thereafter. Protocol-specified wait periods separated each instillation.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
62.6 years
STANDARD_DEVIATION 13.23 • n=10 Participants
|
70.2 years
STANDARD_DEVIATION 8.78 • n=50 Participants
|
68.4 years
STANDARD_DEVIATION 13.68 • n=108 Participants
|
63.9 years
STANDARD_DEVIATION 10.32 • n=9 Participants
|
66.2 years
STANDARD_DEVIATION 11.82 • n=22 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=10 Participants
|
11 Participants
n=50 Participants
|
11 Participants
n=108 Participants
|
12 Participants
n=9 Participants
|
46 Participants
n=22 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=10 Participants
|
2 Participants
n=50 Participants
|
3 Participants
n=108 Participants
|
2 Participants
n=9 Participants
|
9 Participants
n=22 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=10 Participants
|
1 Participants
n=50 Participants
|
0 Participants
n=108 Participants
|
1 Participants
n=9 Participants
|
3 Participants
n=22 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=10 Participants
|
12 Participants
n=50 Participants
|
14 Participants
n=108 Participants
|
13 Participants
n=9 Participants
|
52 Participants
n=22 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=108 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=22 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=108 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=22 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=10 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=108 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=22 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=10 Participants
|
3 Participants
n=50 Participants
|
1 Participants
n=108 Participants
|
1 Participants
n=9 Participants
|
7 Participants
n=22 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=108 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=22 Participants
|
|
Race/Ethnicity, Customized
White
|
11 Participants
n=10 Participants
|
10 Participants
n=50 Participants
|
12 Participants
n=108 Participants
|
13 Participants
n=9 Participants
|
46 Participants
n=22 Participants
|
|
Race/Ethnicity, Customized
Multi-Racial
|
1 Participants
n=10 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=108 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=22 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=10 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=108 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=22 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=10 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=108 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=22 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=108 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=22 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=10 Participants
|
13 participants
n=50 Participants
|
14 participants
n=108 Participants
|
14 participants
n=9 Participants
|
55 participants
n=22 Participants
|
PRIMARY outcome
Timeframe: Up to Day 1 post drop instillationPopulation: Safety Analysis Set: All subjects who received at least one dose of artificial tears or one dose of 0.003% AR-15512. AEs for 0.003% AR-15512 are reported by intervention (all instillation variations combined) as specified in the protocol and statistical analysis plan.
Treatment-emergent adverse events (TEAEs) were defined as any event that occurred or worsened on or after the day that study intervention was initiated. No hypothesis testing was prespecified for this endpoint.
Outcome measures
| Measure |
Artificial Tears
n=55 Participants
Commercially available, preservative-free lubricant eye drops administered topically
|
0.003% AR-15512
n=55 Participants
Investigational ophthalmic solution administered topically
|
|---|---|---|
|
Percentage of Subjects With Ocular Treatment-Emergent Adverse Events Attributed to Study Intervention
|
0 percentage of subjects
|
3.6 percentage of subjects
|
Adverse Events
Pretreatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Artificial Tears
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
0.003% AR-15512
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
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