A Phase 3 Study of VVN461 Ophthalmic Solution for Noninfectious Anterior Uveitis
Not Applicable
Not yet recruiting
- Conditions
- Non-infectious Anterior Uveitis
- Interventions
- Drug: VVN461 Ophthalmic Solution 1.0%Drug: 1.0% prednisolone acetate
- Registration Number
- NCT07136805
- Lead Sponsor
- VivaVision Biotech, Inc
- Brief Summary
This is a multicenter, randomized, single-masked, active-controlled, parallel, Phase III pivotal study in China
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 152
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VVN461, 1.0% VVN461 Ophthalmic Solution 1.0% VVN461 Ophthalmic Solution, 1.0% 1.0% prednisolone acetate 1.0% prednisolone acetate 1.0% prednisolone acetate, Pred Forte
- Primary Outcome Measures
Name Time Method Change from baseline in anterior chamber cell (ACC) grade in the study eye at Day 14 Day 14
- Secondary Outcome Measures
Name Time Method The proportion of subjects with ACC grade of 0 in the study eye at Day 14 Day 14