Study Evaluating the Safety and Efficacy of AR-15512 (COMET-3)
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.
Timeline
- Start
- 2022-07-18
- Primary completion
- 2023-10-17
- Completion
- 2023-10-17
Outcome
Met primary endpoint
paper The primary end point was met in both studies PMID 41038456 ↗
registry 0.003% AR-15512 vs AR-15512 Vehicle; p <0.0001; Difference in Percentages 38.8 (95% CI 30.8 to 46.8) NCT05360966 ↗
release “In both pivotal efficacy and safety studies (COMET-2 and COMET-3), the primary endpoint was achieved (p <0.0001)” alcon.com ↗
Publications
- Periman LM, Lappin CJ, McDonald MB, Coats J, Pattar GR, Okoro T, Lighthizer N, Senchyna M, Nijm LM. Improvement in Visual-Tasking Daily Living Activities and Work Productivity in Patients with Dry Eye Disease: Integrated Analysis of COMET Studies. Ophthalmol Ther. 2026 Jul 18. doi: 10.1007/s40123-026-01421-1. Online ahead of print.
- Pattar GR, Wirta D, Jerkins G, Paauw J, McLaurin EB, Liu A, Evans DG, Kenyon K, Cline N, Gupta PK, Meng I, Senchyna M; COMET-2 and COMET-3 Study Groups. Acoltremon Ophthalmic Solution 0.003% for Signs and Symptoms of Dry Eye Disease: Results of Phase 3 Pivotal COMET-2 and COMET-3 Studies. Ophthalmology. 2026 May;133(5):563-574. doi: 10.1016/j.ophtha.2025.09.018. Epub 2025 Sep 30.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acoltremon | Small molecule | 0.003 % | Topical |