NCT05285644

Study Evaluating the Safety and Efficacy of AR-15512

A Phase 3 Study Evaluating the Safety and Efficacy of AR-15512, a Cold Thermoreceptor Modulator, for the Treatment of Dry Eye Disease (COMET-2)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 465 (actual)
• Sponsor: Aerie Pharmaceuticals · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

Detailed description

At the end of the Screening Visit, all qualified subjects will be assigned to administer one drop of AR-15512 Vehicle twice a day to both eyes for approximately 14 days (vehicle run-in period). After the vehicle run-in period, subjects will be re-evaluated for signs and symptoms of Dry Eye Disease (DED). Subjects who requalify based on inclusion/exclusion criteria will be enrolled in the study and randomized in a 1:1 ratio to receive 0.003% AR-15512 or AR-15512 Vehicle administered as 1 drop in each eye twice a day for 90 days. At the end of the Day 90 visit, subjects will exit the study. Aerie Pharmaceuticals was acquired by Alcon on November 22, 2022.

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
DRUG	0.003% AR-15512 ophthalmic solution	Administered via topical ocular instillation
DRUG	AR-15512 vehicle ophthalmic solution	Inactive ingredients administered via topical ocular instillation

Timeline

• Start date: 2022-05-09
• Primary completion: 2023-07-24
• Completion: 2023-07-24
• First posted: 2022-03-17
• Last updated: 2025-07-23
• Results posted: 2025-07-23

Locations

23 sites across 1 country: United States

Regulatory

• FDA-regulated drug study