NCT05493111

A Long-Term Safety Study Evaluating the Safety and Systemic Exposure of AR-15512

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 275 (actual)
• Sponsor: Aerie Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

At the end of the Screening Visit, subjects will undergo a protocol-specified washout period for prohibited prior and concomitant therapies. At the Baseline Visit, subjects who qualify based on inclusion/exclusion criteria will be enrolled in the study and randomized in a 2:1 ratio to receive 0.003% AR-15512 or AR-15512 Vehicle administered as 1 drop in each eye twice a day for 365 days (12 months). At the end of the Day 365 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	Active ingredients administered via topical ocular instillation
DRUG	AR-15512 vehicle ophthalmic solution	Inactive ingredients administered via topical ocular instillation

Timeline

• Start date: 2022-11-01
• Primary completion: 2024-02-28
• Completion: 2024-02-28
• First posted: 2022-08-09
• Last updated: 2025-08-13
• Results posted: 2025-08-13

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study