A Clinical Trial to Assess the Safety and Efficacy of Subjects With Dry Eye Disease

Completed · Phase 3

Conditions studied: Dry Eye Disease

In brief

A Multicenter, Phase 3, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Environment Exposure Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap

Key facts

Study ID

NCT06424444

Run by

Aldeyra Therapeutics, Inc.

People needed

421

Starts

2024-04-29

Expected to finish

2024-11-03

Last updated by the study team

2025-10-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• at least 18 years of age;
• written informed consent and sign the Health Information Portability and Accountability Act (HIPAA) form;
• history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1

You may not qualify if…

• ongoing ocular infection (bacterial, viral, or fungal) or active ocular inflammation at Visit 1;
• contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the trial;
• eye drops within 2 hours of Visit 1;
• laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
• topical ocular cyclosporine, lifitegrast, corticosteroid, or any other topical ocular prescription medication within 90 days of Visit 1

Where it is running

• Core, Inc. — Shelby, North Carolina, United States

Full record on ClinicalTrials.gov

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