VVN461 Ophthalmic Solution 1.0%: 1 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: 1 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
Study summary
This is a multicenter, randomized, single-masked, active-controlled, parallel, Phase III pivotal study in China
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
* 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 \[SUN criteria\];
Exclusion Criteria:
* 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
Primary outcome measure(s)
Change from baseline in anterior chamber cell (ACC) grade in the study eye at Day 14 — Day 14
Trial sites (2)
Facility
City
Region
Status
The First Affiliated Hospital of Chongqing Medical University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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