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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
123
ADX-102 Ophthalmic Solution (0.5%) administered for approximately four weeks.
Vehicle of ADX-102 Ophthalmic Solution administered for approximately four weeks.
Number of Subjects Who Meet Time to Clearance of Anterior Chamber Cells
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).
Time frame: The efficacy assessment period was 4 weeks; baseline was defined as Day 1.
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UAB Department of Ophthalmology
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Retina-Vitreous Associates Medical Group
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Byers Eye Institute at Stanford University
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