SOLACE Trial - A Phase 3 Trial in Subjects With Non-infectious Anterior-uveitis.
NCT ID: NCT03131154
Last Updated: 2025-02-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
123 participants
INTERVENTIONAL
2017-04-26
2019-04-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ADX-102 Ophthalmic Solution (0.5%)
ADX-102 Ophthalmic Solution (0.5%)
ADX-102 Ophthalmic Solution (0.5%) administered for approximately four weeks.
Vehicle of ADX-102 Ophthalmic Solution
Vehicle of ADX-102 Ophthalmic Solution
Vehicle of ADX-102 Ophthalmic Solution administered for approximately four weeks.
Interventions
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ADX-102 Ophthalmic Solution (0.5%)
ADX-102 Ophthalmic Solution (0.5%) administered for approximately four weeks.
Vehicle of ADX-102 Ophthalmic Solution
Vehicle of ADX-102 Ophthalmic Solution administered for approximately four weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
85 Years
ALL
No
Sponsors
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Aldeyra Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Retina Consultants of Houston
The Woodlands, Texas, United States
Virginia Eye Consultants
Norfolk, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ADX-102-UV-005
Identifier Type: -
Identifier Source: org_study_id
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