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
- 125
- 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 Efficacy of ADX-102 on anterior chamber cell count using an anterior uveitis grading scale. Efficacy assessment period (Day 1 through Day 29) Evaluate the efficacy of ADX-102 Ophthalmic Solution on anterior chamber cell count in subjects with non-infectious anterior uveitis.
- Secondary Outcome Measures
Name Time Method Efficacy of ADX-102 on anterior chamber flare using an anterior uveitis grading scale. Efficacy assessment period (Day 1 through Day 29) Evaluate the signs and symptoms of ADX-102 Ophthalmic Solution on anterior chamber flare in subjects with non-infectious anterior uveitis.
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