SOLACE Trial - A Phase 3 Trial in Subjects With Non-infectious Anterior-uveitis.
- Conditions
- Non-infectious Anterior Uveitis
- Interventions
- Drug: ADX-102 Ophthalmic Solution (0.5%)Drug: Vehicle of ADX-102 Ophthalmic Solution
- Registration Number
- NCT03131154
- Lead Sponsor
- Aldeyra Therapeutics, Inc.
- Brief Summary
A Phase 3, randomized, double-masked, vehicle-controlled trial to evaluate the safety and efficacy of ADX-102 ophthalmic solution in Subjects with non-infectious anterior-uveitis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 123
- Male or female subjects aged ≥ 18 years and ≤ 85 years.
- Subjects with acute non-infectious anterior uveitis with onset of symptoms within the previous 2 weeks.
- Best corrected visual acuity (BCVA) better than or equal to 35 letters in the study eye and 65 letters in the non-study eye using ETDRS testing.
- Have severe/serious ocular pathology in the study eye(s) which may preclude study completion, in the judgement of the Investigator.
- Active intermediate or posterior uveitis in the study eye(s).
- Previous anterior uveitis episode in the study eye ≤ 4 weeks prior to screening.
- Have participated in another investigational device or drug study within 30 days prior to screening.
- Participation in a prior ADX-102 study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ADX-102 Ophthalmic Solution (0.5%) ADX-102 Ophthalmic Solution (0.5%) - Vehicle of ADX-102 Ophthalmic Solution Vehicle of ADX-102 Ophthalmic Solution -
- Primary Outcome Measures
Name Time Method Number of Subjects Who Meet Time to Clearance of Anterior Chamber Cells The efficacy assessment period was 4 weeks; baseline was defined as Day 1. Time to clearance of anterior chamber cells was defined as the time from initiation of study drug to when a cell count of 0 was achieved and maintained (without cell count increases to \>0) to Week 4 and without rescue or discontinuation due to rescue prior to Week 4. Anterior chamber cell count is the number of cells visible within the anterior chamber of the eye, measured using a slit lamp and following SUN (Standardization of Uveitis Nomenclature) where a cell count \<1 is Grade 0 (absent) and a cell count of \>50 is Grade 4+ (severe).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (26)
Walman Eye Center
🇺🇸Sun City, Arizona, United States
Retina-Vitreous Associates Medical Group
🇺🇸Beverly Hills, California, United States
Levenson Eye Associates
🇺🇸Jacksonville, Florida, United States
Center for Retina and Macular Disease
🇺🇸Winter Haven, Florida, United States
Oakland Ophthalmic Surgery
🇺🇸Birmingham, Michigan, United States
Valley Eye Physicians & Surgeons
🇺🇸Ayer, Massachusetts, United States
Ocular Immunology & Uveitis Foundation
🇺🇸Waltham, Massachusetts, United States
Metropolitan Eye Research and Surgery Institute
🇺🇸Palisades Park, New Jersey, United States
Oregon Retina, LLP
🇺🇸Eugene, Oregon, United States
Virginia Eye Consultants
🇺🇸Norfolk, Virginia, United States
Byers Eye Institute at Stanford University
🇺🇸Palo Alto, California, United States
M&M Eye Institute
🇺🇸Prescott, Arizona, United States
Corneal Consultants of Colorado
🇺🇸Littleton, Colorado, United States
Bergstrom Eye Research
🇺🇸Fargo, North Dakota, United States
Retinal Research Institute
🇺🇸Phoenix, Arizona, United States
University of California, Irvine
🇺🇸Irvine, California, United States
Retinal Consultants Medical Group, Inc.
🇺🇸Sacramento, California, United States
Midwest Eye Institute
🇺🇸Indianapolis, Indiana, United States
Tauber Eye Center
🇺🇸Kansas City, Missouri, United States
Retina Consultants of Houston
🇺🇸The Woodlands, Texas, United States
UAB Department of Ophthalmology
🇺🇸Birmingham, Alabama, United States
John Hopkins
🇺🇸Baltimore, Maryland, United States
Retina and Uveitis Consultants of Texas
🇺🇸San Antonio, Texas, United States
Danbury Eye Physicians & Surgeons
🇺🇸Danbury, Connecticut, United States
Ophthalmic Consultants of Boston
🇺🇸Boston, Massachusetts, United States
Texas Retina Associates
🇺🇸Dallas, Texas, United States