NCT04498182

A Phase 2b Study Evaluating the Safety and Efficacy of AR-15512 Ophthalmic Solution for the Treatment of Dry Eye Disease

A Phase 2b Study Evaluating the Safety and Efficacy of AR-15512 Ophthalmic Solution for the Treatment of Dry Eye Disease (COMET-1)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 369 (actual)
• Sponsor: Aerie Pharmaceuticals · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2b, multicenter, vehicle-controlled, double-masked, randomized study. All subjects enrolled will have dry eye disease. The study consists of Screening and Baseline visits to determine eligibility, followed by efficacy assessments at Day 14 (Visit 3), 28 (Visit 4) and 84 (Visit 5/Study Exit). Safety will be assessed at all study visits.

Detailed description

At the end of the Screening Visit, all qualified subjects will be assigned to administer AR-15512 vehicle twice a day to both eyes for 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 randomized in a 1:1:1 ratio to receive AR-15512 0.0014% (lower dose), AR-15512 0.003% (higher dose) or AR-15512 vehicle administered as 1 drop in each eye twice daily for 84 days. This study will utilize a Controlled Adverse Environment (CAE) chamber, which serves to (1) minimize the factors that could impact the evaluation (temperature, humidity, and airflow) and (2) stress the ocular surface in a safe, standardized, controlled, and reproducible manner. Subjects will be exposed to the CAE for approximately 90 minutes during each CAE visit. Subjects will be exposed to the CAE at the Screening and Baseline visits as well as on Day 28 (Visit 4) and Day 84 (Visit 5). Efficacy endpoints will be evaluated pre- and post- exposure to the CAE. Aerie Pharmaceuticals was acquired by Alcon on November 22, 2022.

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
DRUG	AR-15512 Ophthalmic Solution	Ophthalmic solution administered via topical ocular instillation in one of two dose concentrations: 0.0014% (lower dose) or 0.003% (higher dose)
DRUG	AR-15512 Ophthalmic Solution Vehicle	Ophthalmic solution vehicle administered via topical ocular instillation

Timeline

• Start date: 2020-10-26
• Primary completion: 2021-07-17
• Completion: 2021-07-17
• First posted: 2020-08-04
• Last updated: 2024-08-28
• Results posted: 2024-08-06

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study