A Clinical Trial to Assess Subjects With Dry Eye Disease.

Aldeyra Therapeutics

Status and phase: Completed; Phase 2

Conditions: Dry Eye

Treatments: Drug: Reproxalap Ophthalmic Solution (0.25%); Drug: Vehicle Ophthalmic Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT04971031

ADX-102-DED-024

Details and patient eligibility

About

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

Enrollment: 158 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18 years of age (either gender and any race);
2. Reported history of dry eye for at least 6 months prior to Visit 1;
3. Reported history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1.

Exclusion criteria

1. Clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
2. Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
3. Contact lens use within 7 days of Visit 1 or anticipate using contact lenses during the trial;
4. Eye drop use within 2 hours of Visit 1;
5. Previous laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
6. Cyclosporine 0.05% or 0.09% or lifitegrast 5.0% ophthalmic solution use within 90 days of Visit 1;
7. Be receiving systemic corticosteroid therapy (not including inhaled corticosteroids) within 14 days of Visit 1 or anticipate such therapy throughout the study period;
8. Planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of Visit 1;
9. Temporary punctal plugs during the study that have not been stable within 30 days of Visit 1.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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158 participants in 2 patient groups, including a placebo group

Reproxalap Ophthalmic Solution (0.25%) administered 7 times over two consecutive days.

Experimental group

Treatment:

Drug: Reproxalap Ophthalmic Solution (0.25%)

Vehicle Ophthalmic Solution administered 7 times over two consecutive days.

Placebo Comparator group

Treatment:

Drug: Vehicle Ophthalmic Solution