Study Evaluating the Safety and Efficacy of AR-15512 (COMET-3)

NCT ID: NCT05360966

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 467 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-18
• Study Completion Date: 2023-10-17

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

0.003% AR-15512

0.003% AR-15512 ophthalmic solution, one drop in each eye twice a day for 90 days

Group Type: EXPERIMENTAL

0.003% AR-15512 ophthalmic solution

Intervention Type: DRUG

Administered via topical ocular instillation

AR-15512 Vehicle

AR-15512 vehicle ophthalmic solution, one drop in each eye twice a day for 90 days

Group Type: PLACEBO_COMPARATOR

AR-15512 vehicle ophthalmic solution

Intervention Type: DRUG

Inactive ingredients administered via topical ocular instillation

Interventions

0.003% AR-15512 ophthalmic solution

Administered via topical ocular instillation

Intervention Type: DRUG

AR-15512 vehicle ophthalmic solution

Inactive ingredients administered via topical ocular instillation

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Signs and symptoms of dry eye disease (DED) at the Screening and Baseline visits;
• Corrected visual acuity of +0.70 logarithm Minimum angle of resolution (LogMAR) or better in both eyes at Screening and Baseline visits;

Exclusion Criteria

• History or presence of any ocular disorder or condition (other than DED) in either eye that would, in the opinion of the investigator, likely interfere with the interpretation of the study results or subject safety;
• Regular use of lid hygiene within 14 days prior to the Screening visit or any planned use during the study;
• Use of artificial tears within 2 hours prior to the Screening visit or anticipated use during the study;
• Medication use as specified in the protocol;
• History or presence of significant systemic disease;

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aerie Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scientific Advisor, Clinical R&D

Role: STUDY_DIRECTOR

Alcon Research, LLC

Locations

Reeve Woods Eye Center

Chico, California, United States

NVision Clinical Research, LLC

Fullerton, California, United States

Eye Research Foundation

Newport Beach, California, United States

Shultz Vision

Northridge, California, United States

NVision Clinical Research, LLC

Torrance, California, United States

Argus Research Center

Cape Coral, Florida, United States

Jackson Eye

Lake Villa, Illinois, United States

Wyse Eyecare

Northbrook, Illinois, United States

Pankratz Eye Institute

Columbus, Indiana, United States

Andover Eye Associates

Andover, Massachusetts, United States

Boston Vision

Milford, Massachusetts, United States

Andover Eye Associates - Raynham

Raynham, Massachusetts, United States

AdvanceMed Clinical Research

Las Vegas, Nevada, United States

NVision Clinical Research, LLC

Rochester, New York, United States

Oculus Research

Garner, North Carolina, United States

Wilmington Eye

Leland, North Carolina, United States

Pure Ophthalmic Research

Mint Hill, North Carolina, United States

Erie Retina Research

Erie, Pennsylvania, United States

Andover Eye Associates

Warwick, Rhode Island, United States

Keystone Research

Austin, Texas, United States

Axis Clinicals

Dallas, Texas, United States

Piedmont Eye Center

Lynchburg, Virginia, United States

Virginia Eye Institute

Richmond, Virginia, United States

Countries

United States

References

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 Studies COMET-2 and COMET-3. Ophthalmology. 2025 Sep 30:S0161-6420(25)00605-0. doi: 10.1016/j.ophtha.2025.09.018. Online ahead of print.

Reference Type: DERIVED

PMID: 41038456 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

AR-15512-CS302

Identifier Type: -

Identifier Source: org_study_id