Study Evaluating the Safety and Efficacy of AR-15512

NCT ID: NCT05285644

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 465 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-09
• Study Completion Date: 2023-07-24

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

Global Research Management, Inc

Glendale, California, United States

Premiere Practice Management, LLC

Torrance, California, United States

Vision Institute

Colorado Springs, Colorado, United States

The Eye Care Group

Waterbury, Connecticut, United States

Segal Drug Trials, Inc.

Delray Beach, Florida, United States

Michael Washburn Center for Ophthalmic Research, LLC

Indianapolis, Indiana, United States

Butchertown Clinical Trials

Louisville, Kentucky, United States

Central Maine Eye Care

Lewiston, Maine, United States

Moyes Eye Center

Kansas City, Missouri, United States

Center for Sight

Henderson, Nevada, United States

Core, Inc.

Shelby, North Carolina, United States

Bergstrom Eye Research

Fargo, North Dakota, United States

Verum Research

Eugene, Oregon, United States

Erie Retina Research

Erie, Pennsylvania, United States

Advancing Vision Research

Goodlettsville, Tennessee, United States

Total Eye Care, PA

Memphis, Tennessee, United States

Advancing Vision Research

Smyrna, Tennessee, United States

Austin Clinical Research

Austin, Texas, United States

Valley Retina Institute, PA

Harlingen, Texas, United States

Valley Retina Institute, PA

McAllen, Texas, United States

Eye Clinics of South Texas

San Antonio, Texas, United States

R and R Eye Research, LLC

San Antonio, Texas, United States

Alpine Research Organization Inc.

Clinton, Utah, 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-CS301

Identifier Type: -

Identifier Source: org_study_id