SOLACE Trial - A Phase 3 Trial in Subjects With Non-infectious Anterior-uveitis.

Completed · Phase 3

Conditions studied: Non-infectious Anterior Uveitis

In brief

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.

Key facts

Study ID

NCT03131154

Run by

Aldeyra Therapeutics, Inc.

People needed

123

Starts

2017-04-26

Expected to finish

2019-04-26

Last updated by the study team

2025-02-10

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UAB Department of Ophthalmology — Birmingham, Alabama, United States
• Retinal Research Institute — Phoenix, Arizona, United States
• M&M Eye Institute — Prescott, Arizona, United States
• Walman Eye Center — Sun City, Arizona, United States
• Retina-Vitreous Associates Medical Group — Beverly Hills, California, United States
• University of California, Irvine — Irvine, California, United States
• Byers Eye Institute at Stanford University — Palo Alto, California, United States
• Retinal Consultants Medical Group, Inc. — Sacramento, California, United States
• Corneal Consultants of Colorado — Littleton, Colorado, United States
• Danbury Eye Physicians & Surgeons — Danbury, Connecticut, United States
• Levenson Eye Associates — Jacksonville, Florida, United States
• Center for Retina and Macular Disease — Winter Haven, Florida, United States
• Midwest Eye Institute — Indianapolis, Indiana, United States
• John Hopkins — Baltimore, Maryland, United States
• Valley Eye Physicians & Surgeons — Ayer, Massachusetts, United States
• Ophthalmic Consultants of Boston — Boston, Massachusetts, United States
• Ocular Immunology & Uveitis Foundation — Waltham, Massachusetts, United States
• Oakland Ophthalmic Surgery — Birmingham, Michigan, United States
• Tauber Eye Center — Kansas City, Missouri, United States
• Metropolitan Eye Research and Surgery Institute — Palisades Park, New Jersey, United States
• Bergstrom Eye Research — Fargo, North Dakota, United States
• Oregon Retina, LLP — Eugene, Oregon, United States
• Texas Retina Associates — Dallas, Texas, United States
• Retina Consultants of Houston — Houston, Texas, United States
• Retina and Uveitis Consultants of Texas — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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