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

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 Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease

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

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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