This is a multicenter, double-masked, randomized, active-controlled, parallel-comparison study conducted at sites in the China in subjects with Noninfectious Anterior Uveitis
In this study, subjects who meet the inclusion/exclusion criteria will be randomized to receive one of the three treatments prednisolone acetate during the Screening/Baseline Visit (Day-2 to Day 1). Starting from Visit 1 (Day 1), subjects will be administered one drop of the investigational product in the study eye in following dose regimens: 6 times per day (Q2h, 2 hours apart) for 7 days; 4 times per day (QID) for 7 days;2 times per day (BID) for 7 days;once a day (QD) for 7 days. Subjects will return to clinic for study assessments on Day 3 (Visit 2), Day 7 (Visit 3), Day 14 (Visit 4), Day 21 (Visit 5) and Day 28 (Visit 6, end of study) or early withdrawal/termination visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
89
VVN461 Ophthalmic Solution, 1.0%, for up to 28 days
VVN461 Ophthalmic Solution, 0.5%, for up to 28 days
Prednisolone acetate, 1%, for up to 28 days
Peking University First Hospital
Beijing, China
ACC score of ≥2 grade from baseline at Day 14
Proportion of subjects with improvement in ACC score of ≥2 grade from baseline at Day 14
Time frame: Day 14
ACC score of 0
Proportion of subjects with an ACC score of 0 at any visit
Time frame: Baseline to Day 28
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