CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 467 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.

Search/NCT05360966
NCT05360966Phase 3Completed
CompareCT.gov

A Phase 3 Study Evaluating the Safety and Efficacy of AR-15512, a Cold Thermoreceptor Modulator, for the Treatment of Dry Eye Disease (COMET-3)

Aerie Pharmaceuticals·interventional·Posted May 4, 2022·Updated Jul 23, 2025

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 467 participants across 23 sites.

Detailed Summary

This will be a Phase 3, multicenter, vehicle-controlled, double-masked, randomized study conducted at approximately 20 sites in the United States. All subjects enrolled will have dry eye disease (DED). The study will consist of Screening (Day -14) and Baseline (Day 1) visits as well as visits at Day 7, Day 14, Day 28, and Day 90 (Study Exit) for an individual duration of participation of approximately 15 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Disease
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedMay 4, 2022
Enrollment StartJul 18, 2022
Primary CompletionOct 17, 2023
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 4.2 years ago

Interventions

0.003% AR-15512 ophthalmic solutiondrug

Administered via topical ocular instillation

AR-15512 vehicle ophthalmic solutiondrug

Inactive ingredients administered via topical ocular instillation