A Multi-Center, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Clinical Trial of Reproxalap to Assess the Safety and Efficacy in Subjects With Dry Eye Disease

Aldeyra Therapeutics

Status and phase

Completed

Phase 2

Conditions

Dry Eye

Treatments

Drug: Vehicle Ophthalmic Solution (0.25% Novel Formulation) QID to BID

Drug: Reproxalap Ophthalmic Solution (0.25% Novel Formulation) QID to BID

Study type

Interventional

Funder types

Industry

Identifiers

NCT03916042

ADX-102-DED-013

Details and patient eligibility

About

A Multi-Center, Phase 2, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Clinical Trial to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution (0.25% Novel Formulation) Compared to Vehicle in Subjects with Dry Eye Disease

Enrollment

206 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 6 months of Visit 1

Exclusion criteria

Have any clinically significant slit-lamp findings at Visit 1, including active blepharitis; meibomian gland dysfunction (MGD); lid margin inflammation; or active ocular allergies that require therapeutic treatment, or, in the opinion of the investigator may interfere with the assessment of the safety or efficacy of reproxalap 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 lenses during the study;
Have used any eye drops within 2 hours of Visit 1;
Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
Have used ophthalmic cyclosporine or lifitegrast 5.0% ophthalmic solution within 90 days of Visit 1;
Have any planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of Visit 1;
Have used temporary or permanent punctal plugs within 30 days prior to Visit 1 or anticipate their use during the study period