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

Phase

Condition

Dry Eyes

Sjogren's Syndrome

Eyelid Inflammation

Treatment

Vehicle ophthalmic solution

Reproxalap ophthalmic solution (0.25%)

Clinical Study ID

NCT06424444

ADX-102-DED-031

Ages > 18
All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

ongoing ocular infection (bacterial, viral, or fungal) or active ocular inflammationat Visit 1;
contact lenses within 7 days of Visit 1 or anticipate using contact lenses duringthe 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 topicalocular prescription medication within 90 days of Visit 1

Study Design