Overview

A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease

Status:
Recruiting
Trial end date:
2022-06-30
Target enrollment:
0
Participant gender:
All
Summary
A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of 0.25% Reproxalap Ophthalmic Solution in Subjects with Dry Eye Disease
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Aldeyra Therapeutics, Inc.
Treatments:
Ophthalmic Solutions
Pharmaceutical Solutions
Criteria
Inclusion Criteria:

- 18 years of age (either gender and any race);

- Reported history of dry eye for at least 6 months prior to Visit 1;

- History of use or desire to use eye drops for dry eye symptoms within 6 months of
Visit 1.

Exclusion Criteria:

- 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;

- Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), or active
ocular inflammation at Visit 1;

- Contact lens use within 7 days of Visit 1 or anticipate using contact lenses during
the trial;

- Eye drop use within 2 hours of Visit 1;

- Previous laser-assisted in situ keratomileusis (LASIK) surgery within the last 12
months;

- Cyclosporine 0.05% or 0.09% or lifitegrast 5.0% ophthalmic solution within 90 days of
Visit 1;

- Planned ocular and/or lid surgeries over the study period or any ocular surgery within
6 months of Visit 1;

- Temporary punctal plugs during the study that have not been stable within 30 days of
Visit 1.