Status:
COMPLETED
A Multi-Center, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled, Clinical Study to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease
Lead Sponsor:
Aldeyra Therapeutics, Inc.
Conditions:
Dry Eye Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A Multi-Center, Phase 2b, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled, Clinical Study to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution (0.25% and 0.1%) Compared to...
Eligibility Criteria
Inclusion
- Be at least 18 years of age of either gender and any race;
- Have a reported history of dry eye for at least 6 months prior to Visit 1;
- Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1;
Exclusion
- Have any 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;
- Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
- Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
- Have used any eye drops within 2 hours of Visit 1;
- Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
- Have used cyclosporine 0.05% or lifitigrast 5.0% ophthalmic solution within 90 days of Visit 1;
- Have any planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of Visit 1;
- Be using or anticipate using temporary punctal plugs during the study that have not been stable within 30 days of Visit 1;
Key Trial Info
Start Date :
January 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 11 2018
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03404115
Start Date
January 2 2018
End Date
July 11 2018
Last Update
February 6 2025
Active Locations (6)
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1
The Eye Care Group
Waterbury, Connecticut, United States, 06708
2
Midwest Cornea Associates
Indianapolis, Indiana, United States, 46290
3
Central Maine Eye Care
Lewiston, Maine, United States, 04240
4
Andover Eye Associates
Andover, Massachusetts, United States, 01810