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 on Day 28
For FDA submission: the proportion of subjects with Anterior Chamber Cell (ACC) Grade=0 (0 cells) on Day 28 in the study eye. For submission to European Medicines Agency (EMA) related countries: the proportion of subjects with ACC Grade = 0 or 1 on Day 28 in the study eye.
Time frame: 28 days
Change from baseline (Day 1) in ACC Grade on Day 28 in the study eye
Time frame: 28 days
Anterior Chamber Cell (ACC) grade on Day 21
For FDA submission: Proportion of subjects with ACC Grade=0 on Day 21 in the study eye. For submission to EMA related countries: Proportions of subjects with ACC Grade = 0 or 1 on Day 21 in the study eye.
Time frame: 21 days
Change from baseline in ACC Grade on Day 21.
Time frame: 21 days
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