About this trial
This is a multicenter, randomized, single-masked, active-controlled, parallel, Phase III pivotal study in China
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
At the time of signing the informed consent form (ICF), the subject must be aged 18 to 70 years (inclusive);
At screening, the affected eye is diagnosed with non-infectious anterior uveitis (acute or recurrent acute, only unilateral eye affected patients are included);
At screening, the ACC grade of the affected eye is 2+ or 3+ [SUN criteria];
At screening, the ACF grade of the affected eye is ≥1 [SUN criteria];
Disqualifiers
At screening, the affected eye has an ACC grade of 4+ or hypopyon
Diagnosis of intermediate uveitis, posterior uveitis, or panuveitis in either eye at the time of screening
Trial design
Parallel
Treatments tested in this trial
VVN461 Ophthalmic Solution 1.0%
Drug1 drop for study eye each time, 6 times daily (Q2h) for 7 days; 4 times daily (QID) for 7 days; 2 times daily (BID) for 7 days; 1 time daily for 7 days
1.0% prednisolone acetate
Drug1 drop for study eye each time, 6 times daily (Q2h) for 7 days; 4 times daily (QID) for 7 days; 2 times daily (BID) for 7 days; 1 time daily for 7 days
Treatment groups
Trial outcomes
Primary outcomes
Change from baseline in anterior chamber cell (ACC) grade in the study eye at Day 14
Secondary outcomes
The proportion of subjects with ACC grade of 0 in the study eye at Day 14
Locations
Sponsors and contacts
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