The RENEW Trial: A Multi-Center, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Adaptive Phase 3 Clinical Trial to Assess the Safety and Efficacy of Subjects With Dry Eye Disease

Inclusion Criteria:

• Be at least 18 years of age of either gender and any race;

• Have a reported history of dry eye for at least 6 months prior to Visit 1;

• Have a history of use or desire to use eye drops for dry eye symptoms within 6months of Visit 1

Exclusion Criteria:

• Have any clinically significant slit-lamp findings at Visit 1, including activeblepharitis; meibomian gland dysfunction (MGD); lid margin inflammation; or activeocular allergies that require therapeutic treatment, or, in the opinion of theinvestigator may interfere with the assessment of the safety or efficacy ofreproxalap or vehicle;

• Have or be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal)or active ocular inflammation at Visit 1;

• Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lensesduring the study;

• Have used any eye drops within 2 hours of Visit 1;

• Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within thelast 12 months;

• Have used ophthalmic cyclosporine or lifitegrast 5.0% ophthalmic solution within 90days of Visit 1;

• Have any planned ocular and/or lid surgeries over the study period or any ocularsurgery within 6 months of Visit 1;

• Have used temporary or permanent punctal plugs within 30 days prior to Visit 1 oranticipate their use during the study period