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

Aldeyra Therapeutics

Status and phase: Enrolling; Phase 3

Conditions: Dry Eye Disease

Treatments: Drug: Reproxalap ophthalmic solution (0.25%); Drug: Vehicle ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT06424444

ADX-102-DED-031

Details and patient eligibility

About

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

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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400 participants in 2 patient groups, including a placebo group

Reproxalap Ophthalmic Solution (0.25%)

Experimental group

Treatment:

Drug: Reproxalap ophthalmic solution (0.25%)

Vehicle Ophthalmic Solution

Placebo Comparator group

Treatment:

Drug: Vehicle ophthalmic solution