At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 275 enrolled
Drug / intervention
0.003% AR-15512 ophthalmic solution +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Long-Term Safety Study Evaluating the Safety and Systemic Exposure of AR-15512, a Cold Thermoreceptor Modulator, for the Treatment of Dry Eye Disease (COMET-4)
In Brief
A Phase 3 clinical trial evaluating 0.003% AR-15512 ophthalmic solution and AR-15512 vehicle ophthalmic solution for Dry Eye Disease. Completed, enrolled 275 participants across 10 sites.
Detailed Summary
The purpose of this study is to evaluate the safety of topical ophthalmic 0.003% AR-15512 compared to its vehicle dosed twice daily (BID) in subjects with dry eye disease (DED) for 12 months.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Disease
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2023202420252026
First PostedAug 2022
Enrollment StartNov 2022
Primary CompletionFeb 2024
TodayJul 2026
First PostedAug 9, 2022
Enrollment StartNov 1, 2022
Primary CompletionFeb 28, 2024
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 3.9 years ago
Interventions
0.003% AR-15512 ophthalmic solutiondrug
Active ingredients administered via topical ocular instillation
AR-15512 vehicle ophthalmic solutiondrug
Inactive ingredients administered via topical ocular instillation