The primary objective of this study is to evaluate the efficacy and safety of TRS01 eye drops compared to active comparator in subjects with active non-infectious anterior uveitis with or without uveitic glaucoma
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
142
TRS01 eye drops Dosed four times a day (QID)
FDA approved steroid eye drop Dosed four times a day (QID)
La Jolla
La Jolla, California, United States
Anterior Chamber Cell (ACC) Grade = 0 on Day 28
For FDA submission: the percentage of subjects with Anterior Chamber Cell (ACC) Grade=0 (0 cells) on Day 28 in the study eye. ACC=0 is complete resolution of inflammation (0 cells).
Time frame: 28 days
Anterior Chamber Cell (ACC) Grade = 0 or 1 on Day 28
For submission to European Medicines Agency (EMA) related countries: the percentage of subjects with ACC Grade = 0 or 1 on Day 28 in the study eye. ACC=0 is complete resolution of inflammation (0 cells), ACC=1 represent trace cells.
Time frame: 28 days
Change From Baseline (Day 1) in ACC Grade on Day 28 in the Study Eye
Change from baseline in Anterior Chamber Cell (ACC) score (measures ocular inflammation). ACC scale range: 0-4 ACC grade 0 = No cells ACC grade 4 = Severe ACC level Change from baseline measures the mean change in ACC grade on Day 28 in the study eye
Time frame: 28 days
Anterior Chamber Cell (ACC) Grade on Day 21
Proportion of subjects with ACC Grade=0 on Day 21 in the study eye.
Time frame: 21 days
Change From Baseline in ACC Grade on Day 21.
Change from baseline in Anterior Chamber Cell (ACC) score (measures ocular inflammation). ACC scale range: 0-4 ACC grade 0 = No cells ACC grade 4 = Severe ACC level Change from baseline measures the mean change in ACC grade on Day 21 in the study eye
Time frame: 21 days
Anterior Chamber Cell (ACC) Grade = 0 or 1 on Day 21
Proportions of subjects with ACC Grade = 0 or 1 on Day 21 in the study eye. ACC=0 is complete resolution of inflammation (0 cells), ACC=1 represent trace cells.
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Los Angeles
Los Angeles, California, United States
Los Angeles 2
Los Angeles, California, United States
Aurora
Aurora, Colorado, United States
Lakewood
Lakewood, Colorado, United States
Jacksonville
Jacksonville, Florida, United States
Winter Haven
Winter Haven, Florida, United States
Marietta
Marietta, Georgia, United States
Boston
Boston, Massachusetts, United States
Waltham
Waltham, Massachusetts, United States
...and 20 more locations
Time frame: 21 days