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

Last updated: July 22, 2025
Sponsor: Aerie Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Sjogren's Syndrome

Dry Eye Disease

Dry Eyes

Treatment

Vehicle

AR-15512 vehicle ophthalmic solution

AR-15512 Ophthalmic Solution

Clinical Study ID

NCT05360966
AR-15512-CS302
  • Ages > 30
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Key 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) orbetter in both eyes at Screening and Baseline visits;

  • Other protocol-specified inclusion criteria may apply.

Exclusion

Key Exclusion Criteria:

  • History or presence of any ocular disorder or condition (other than DED) in eithereye that would, in the opinion of the investigator, likely interfere with theinterpretation of the study results or subject safety;

  • Regular use of lid hygiene within 14 days prior to the Screening visit or anyplanned use during the study;

  • Use of artificial tears within 2 hours prior to the Screening visit or anticipateduse during the study;

  • Medication use as specified in the protocol;

  • History or presence of significant systemic disease;

  • Other protocol-specified exclusion criteria may apply.

Study Design

Total Participants: 467
Treatment Group(s): 4
Primary Treatment: Vehicle
Phase: 3
Study Start date:
July 18, 2022
Estimated Completion Date:
October 17, 2023

Study 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.

Connect with a study center

  • Reeve Woods Eye Center

    Chico, California 95926
    United States

    Site Not Available

  • NVision Clinical Research - Fullerton

    Fullerton, California 92835
    United States

    Site Not Available

  • NVision Clinical Research, LLC

    Fullerton, California 92835
    United States

    Site Not Available

  • NVision Clinical Research

    La Mesa, California 91942
    United States

    Site Not Available

  • NVision Clinical Research - La Mesa

    La Mesa, California 91942
    United States

    Site Not Available

  • Eye Research Foundation

    Newport Beach, California 92663
    United States

    Site Not Available

  • Schultz Chang Vision

    Northridge, California 91325
    United States

    Site Not Available

  • Shultz Vision

    Northridge, California 91325
    United States

    Site Not Available

  • NVision Clinical Research - Torrance

    Torrance, California 90505
    United States

    Site Not Available

  • NVision Clinical Research, LLC

    Torrance, California 90505
    United States

    Site Not Available

  • Vision Institute

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • Argus Research Center

    Cape Coral, Florida 33904
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida 32801
    United States

    Site Not Available

  • Jackson Eye

    Lake Villa, Illinois 60046
    United States

    Site Not Available

  • Jacksoneye, S.C.

    Lake Villa, Illinois 60046
    United States

    Site Not Available

  • Wyse Eyecare

    Northbrook, Illinois 60062
    United States

    Site Not Available

  • Pankratz Eye Institute

    Columbus, Indiana 47203
    United States

    Site Not Available

  • Andover Eye Associates

    Andover, Massachusetts 01810
    United States

    Site Not Available

  • Andover Eye Associates - Andover

    Andover, Massachusetts 01810
    United States

    Site Not Available

  • Boston Vision

    Milford, Massachusetts 01757
    United States

    Site Not Available

  • Andover Eye Associates - Raynham

    Raynham, Massachusetts 02767
    United States

    Site Not Available

  • AdvanceMed Clinical Research

    Las Vegas, Nevada 89123
    United States

    Site Not Available

  • NVision Clinical Research, LLC

    Rochester, New York 14624
    United States

    Site Not Available

  • Oculus Research

    Garner, North Carolina 27529
    United States

    Site Not Available

  • Wilmington Eye

    Leland, North Carolina 28451
    United States

    Site Not Available

  • Pure Ophthalmic Research

    Mint Hill, North Carolina 28227
    United States

    Site Not Available

  • Erie Retina Research

    Erie, Pennsylvania 16507
    United States

    Site Not Available

  • Andover Eye Associates

    Warwick, Rhode Island 02886
    United States

    Site Not Available

  • Blink Research Center

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Keystone Research

    Austin, Texas 78731
    United States

    Site Not Available

  • Axis Clinicals

    Dallas, Texas 75243
    United States

    Site Not Available

  • Emerson Clinical Research

    Arlington, Virginia 22203
    United States

    Site Not Available

  • Piedmont Eye Center

    Lynchburg, Virginia 24502
    United States

    Site Not Available

  • Virginia Eye Institute

    Richmond, Virginia 23230
    United States

    Site Not Available

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