Status:
COMPLETED
The TRANQUILITY Trial: Clinical Trial to Assess the Efficacy and Safety in Subjects With Dry Eye Disease
Lead Sponsor:
Aldeyra Therapeutics, Inc.
Conditions:
Dry Eye
Dry Eye Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The TRANQUILITY Trial: Multi-Center Randomized, Double-Masked, Parallel Design, Vehicle-Controlled Phase 2/3 Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Co...
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;
- Reported 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 use within 90 days of Visit 1;
- Be receiving systemic corticosteroid therapy (not including inhaled corticosteroids) within 14 days of Visit 1 or anticipate such therapy throughout the study period;
- 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 :
November 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 12 2021
Estimated Enrollment :
329 Patients enrolled
Trial Details
Trial ID
NCT04674358
Start Date
November 21 2020
End Date
September 12 2021
Last Update
March 19 2025
Active Locations (1)
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1
University Clinical Health
Memphis, Tennessee, United States, 38103