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

NCT05360966 | Completed Phase 3 Results FDA Drug

• 1 other identifier: AR-15512-CS302
• Study Type: interventional
• Target: 467
• Locations: 1 country
• Sites: 23

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.

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects Who Achieved Equal to or Greater Than 10 Millimeter Increase From Pre-drop at Baseline to Post-drop on Day 14 in Study Eye Unanesthetized Schirmer Score

  The Schirmer test measures tear production using a filter paper placed on the lower eyelid. The amount of wetting was recorded on a scale from 0 millimeters (mm) (no tear production) to 35 mm (maximum). The test was performed at Day 1 prior to drop exposure and at Day 14 following drop exposure. An increased score represents a positive outcome. One eye (study eye) contributed data to the analysis.

  Baseline (Day 1) pre-drop; Day 14 post-drop

Secondary Outcomes (11)

• Least Squares Mean Change From Baseline in Global Symptom Assessment iN Dry Eye (SANDE) Score on Day 28

  Baseline (Day 1); Day 28

• Least Squares Mean Change From Pre-drop Baseline Unanesthetized Schirmer Score on Post-drop Day 14 (Study Eye)

  Baseline (Day 1) pre-drop; Day 14 post-drop

• Percentage of Subjects Who Achieved Equal to or Greater Than 10 Millimeter Increase From Pre-drop at Baseline to Post-drop on Day 1 in Study Eye Unanesthetized Schirmer Score

  Baseline (Day 1) pre-drop; Day 1 post-drop

• Least Squares Mean Change From Pre-drop Baseline in Unanesthetized Schirmer Score on Post-drop Day 1 (Study Eye)

  Baseline (Day 1) pre-drop; Day 1 post-drop

• Percentage of Subjects Who Achieved Equal to or Greater Than 10 Millimeter Increase From Pre-drop at Baseline to Post-drop on Day 90 in Study Eye Unanesthetized Schirmer Score

  Baseline (Day 1) pre-drop; Day 90 post-drop

Study Arms (2)

0.003% AR-15512

EXPERIMENTAL

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

Drug: 0.003% AR-15512 ophthalmic solution

AR-15512 Vehicle

PLACEBO COMPARATOR

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

Drug: AR-15512 vehicle ophthalmic solution

Interventions

0.003% AR-15512 ophthalmic solution DRUG

Administered via topical ocular instillation

0.003% AR-15512

AR-15512 vehicle ophthalmic solution DRUG

Inactive ingredients administered via topical ocular instillation

AR-15512 Vehicle

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Aerie Pharmaceuticals: lead

Study Sites (23)

Reeve Woods Eye Center

Chico, California, 95926, United States

Location

NVision Clinical Research, LLC

Fullerton, California, 92835, United States

Location

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

Shultz Vision

Northridge, California, 91325, United States

Location

NVision Clinical Research, LLC

Torrance, California, 90505, United States

Location

Argus Research Center

Cape Coral, Florida, 33904, United States

Location

Jackson Eye

Lake Villa, Illinois, 60046, United States

Location

Wyse Eyecare

Northbrook, Illinois, 60062, United States

Location

Pankratz Eye Institute

Columbus, Indiana, 47203, United States

Location

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

Boston Vision

Milford, Massachusetts, 01757, United States

Location

Andover Eye Associates - Raynham

Raynham, Massachusetts, 02767, United States

Location

AdvanceMed Clinical Research

Las Vegas, Nevada, 89123, United States

Location

NVision Clinical Research, LLC

Rochester, New York, 14624, United States

Location

Oculus Research

Garner, North Carolina, 27529, United States

Location

Wilmington Eye

Leland, North Carolina, 28451, United States

Location

Pure Ophthalmic Research

Mint Hill, North Carolina, 28227, United States

Location

Erie Retina Research

Erie, Pennsylvania, 16507, United States

Location

Andover Eye Associates

Warwick, Rhode Island, 02886, United States

Location

Keystone Research

Austin, Texas, 78731, United States

Location

Axis Clinicals

Dallas, Texas, 75243, United States

Location

Piedmont Eye Center

Lynchburg, Virginia, 24502, United States

Location

Virginia Eye Institute

Richmond, Virginia, 23230, United States

Location

Related Publications (1)

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

  PMID: 41038456 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Scientific Advisor, Clinical Research and Development
• Organization: Alcon Research, LLC

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Scientific Advisor, Clinical R&D

  Alcon Research, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Qualified subjects will be enrolled in the study and randomized in a 1:1 ratio within each site to receive 0.003% AR 15512 or AR-15512 vehicle to be administered twice daily (BID) as 1 drop in each eye for 90 days.

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: May 4, 2022
• Study Start: July 18, 2022
• Primary Completion: October 17, 2023
• Study Completion: October 17, 2023
• Last Updated: July 23, 2025
• Results First Posted: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (23)