The RENEW Trial: A Multi-Center, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Adaptive Phase 3 Clinical Trial to Assess the Safety and Efficacy of Subjects With Dry Eye Disease
Completed · Phase 3
Conditions studied: Dry Eye
In brief
The RENEW Trial is a Multi-Center, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Adaptive Phase 3 Clinical Trial to Assess the Safety and Efficacy of Reproxalap 0.25% Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease
Key facts
- Study ID
- NCT03879863
- Run by
- Aldeyra Therapeutics, Inc.
- People needed
- 422
- Starts
- 2019-04-16
- Expected to finish
- 2019-10-04
- Last updated by the study team
- 2025-01-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Have any clinically significant slit-lamp findings at Visit 1, including active blepharitis; meibomian gland dysfunction (MGD); lid margin inflammation; or active ocular allergies that require therapeutic treatment, or, in the opinion of the investigator may interfere with the assessment of the safety or efficacy of reproxalap or vehicle;
- Have or 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 ophthalmic cyclosporine or lifitegrast 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;
- Have used temporary or permanent punctal plugs within 30 days prior to Visit 1 or anticipate their use during the study period
Where it is running
- Eye Research Foundation — Newport Beach, California, United States
Full record on ClinicalTrials.gov
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