Status:
COMPLETED
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
Lead Sponsor:
Aldeyra Therapeutics, Inc.
Conditions:
Dry Eye Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 11 2022
Estimated Enrollment :
757 Patients enrolled
Trial Details
Trial ID
NCT04735393
Start Date
January 26 2021
End Date
October 11 2022
Last Update
November 26 2025
Active Locations (1)
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1
Andover Eye Associates
Andover, Massachusetts, United States, 01810