Study Evaluating the Safety and Efficacy of AR-15512

NCT05285644 | Completed Phase 3 Results FDA Drug

• 1 other identifier: AR-15512-CS301
• Study Type: interventional
• Target: 465
• 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 in 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)

Global Research Management, Inc

Glendale, California, 90027, United States

Location

Premiere Practice Management, LLC

Torrance, California, 90505, United States

Location

Vision Institute

Colorado Springs, Colorado, 80907, United States

Location

The Eye Care Group

Waterbury, Connecticut, 06708, United States

Location

Segal Drug Trials, Inc.

Delray Beach, Florida, 33484, United States

Location

Michael Washburn Center for Ophthalmic Research, LLC

Indianapolis, Indiana, 46240, United States

Location

Butchertown Clinical Trials

Louisville, Kentucky, 40206, United States

Location

Central Maine Eye Care

Lewiston, Maine, 04240, United States

Location

Moyes Eye Center

Kansas City, Missouri, 64154, United States

Location

Center for Sight

Henderson, Nevada, 89052, United States

Location

Core, Inc.

Shelby, North Carolina, 28150, United States

Location

Bergstrom Eye Research

Fargo, North Dakota, 58103, United States

Location

Verum Research

Eugene, Oregon, 97401, United States

Location

Erie Retina Research

Erie, Pennsylvania, 16507, United States

Location

Advancing Vision Research

Goodlettsville, Tennessee, 37072, United States

Location

Total Eye Care, PA

Memphis, Tennessee, 38119, United States

Location

Advancing Vision Research

Smyrna, Tennessee, 37167, United States

Location

Austin Clinical Research

Austin, Texas, 78750, United States

Location

Valley Retina Institute, PA

Harlingen, Texas, 78550, United States

Location

Valley Retina Institute, PA

McAllen, Texas, 78503, United States

Location

Eye Clinics of South Texas

San Antonio, Texas, 78209, United States

Location

R and R Eye Research, LLC

San Antonio, Texas, 78229, United States

Location

Alpine Research Organization Inc.

Clinton, Utah, 84015, 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

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: March 17, 2022
• Study Start: May 9, 2022
• Primary Completion: July 24, 2023
• Study Completion: July 24, 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)