A Phase 3 Study of VVN461 Ophthalmic Solution for Noninfectious Anterior Uveitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VVN461 Ophthalmic Solution 1.0%, 1.0% prednisolone acetate.
- Who it may be relevant to
- Registry conditions: Non-infectious Anterior Uveitis. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multi-center, Randomized, Single-masked, Active-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of 1.0% VVN461 Ophthalmic Solution in Patients With Non-infectious Anterior Uveitis
Overview
This is a multicenter, randomized, single-masked, active-controlled, parallel, Phase III pivotal study in China
Interventions
- Drug 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 - Drug 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
Primary outcome measures
- Change from baseline in anterior chamber cell (ACC) grade in the study eye at Day 14 [Time frame: Day 14]
Secondary outcome measures (1)
- The proportion of subjects with ACC grade of 0 in the study eye at Day 14 [Time frame: Day 14]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07136805 · VVN461-CCS-301