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A Study to Evaluate 0.003% AR-15512 Safety and Drop Attributes | Clinical Trials | Clareo Health

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A Study to Evaluate 0.003% AR-15512 Safety and Drop Attributes

A Phase 3b Study to Evaluate 0.003% AR-15512 Safety and Drop Attributes

NCT06660290•Alcon Research

Summary

The purpose of this study is to evaluate the percentage of ocular adverse events reported in subjects with dry eye disease (DED) between the intervention arm (0.003% AR-15512) and control arm (REFRESH® Classic).

Detailed Description

Subjects will be randomized to one of four sequences of 0.003% AR-15512 ophthalmic solution instillation variations which will be administered after administration of control (REFRESH® Classic). This is a 1-visit study (Screening, Enrollment, Assessments).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Corrected Visual Acuity (Snellen) 20/200 or better in both eyes;
•Good general and ocular health, as determined by the Investigator using medical history, ophthalmic examination and history;
•Capable of giving signed informed consent.

Exclusion Criteria

•Current evidence of other clinically significant ophthalmic disease other than dry eye;
•History of ocular surgery within 1 year of the Study Visit;
•Use of any topical ocular anti-inflammatory medications (for example, Restasis®, Cequa™, Vevye™, Xiidra®), other prescription ophthalmic product for dry eyes, topical ocular corticosteroid, or non-steroidal-anti-inflammatory agents within 30 days of the Study Visit;
•Positive pregnancy test or currently breastfeeding.

Locations (6)

Eye Research Foundation

Newport Beach, California, United States

Vision Institute

Colorado Springs, Colorado, United States

Andover Eye Associates

Andover, Massachusetts, United States

Total Eye Care, PA

Memphis, Tennessee, United States

Advancing Vision Research, LLC

Smyrna, Tennessee, United States

Piedmont Eye Center

Lynchburg, Virginia, United States

Key Dates

Start Date

January 15, 2025

Primary Completion Date

February 6, 2025

Completion Date

February 6, 2025

Last Updated

March 17, 2026

Enrollment

ACTUAL participants

Conditions

Dry Eye Disease

Interventions

0.003% AR-15512 ophthalmic solution

DRUG

Artificial tears

DRUG

A Non-interventional Study to Evaluate the Anti-inflammatory Effects and the Clinical Efficacy of Topical Water Free Cyclosporin 0.1% Eye Drops in Patients With Dry Eye Disease and Associated Ocular Surface Inflammation Non-responding to Artificial Tears: the FOCUS Study

NCT07463950

Dry Eye Disease (DED)

View study

RECRUITING

A Study on the Correlation Between Tear Iron Levels and the Severity of Dry Eye Disease.

NCT07363824

Dry Eye DiseaseIron

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate 0.003% AR-15512 Safety and Drop Attributes

Inclusion Criteria

Exclusion Criteria

A Non-interventional Study to Evaluate the Anti-inflammatory Effects and the Clinical Efficacy of Topical Water Free Cyclosporin 0.1% Eye Drops in Patients With Dry Eye Disease and Associated Ocular Surface Inflammation Non-responding to Artificial Tears: the FOCUS Study

A Study on the Correlation Between Tear Iron Levels and the Severity of Dry Eye Disease.

Supplementary Kelulut Honey Therapy in Juvenile Open-Angle Glaucoma: Effects on IL-6, RNFL and Dry Eye

Role of Corneal Nerves in Dry Eye Disease

Moderate-to-Severe Dry Eye Disease Relief Using Acoltremon

Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD