A Phase 3 Study of VVN461 Ophthalmic Solution for Noninfectious Anterior Uveitis

VivaVision Biotech

Status and phase: Begins enrollment this month; Phase 3

Conditions: Non-infectious Anterior Uveitis

Treatments: Drug: 1.0% prednisolone acetate; Drug: VVN461 Ophthalmic Solution 1.0%

Study type: Interventional

Funder types: Industry

Identifiers

NCT07136805

VVN461-CCS-301

Details and patient eligibility

About

This is a multicenter, randomized, single-masked, active-controlled, parallel, Phase III pivotal study in China

Enrollment: 152 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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152 participants in 2 patient groups

VVN461, 1.0%

Experimental group

Description:

VVN461 Ophthalmic Solution, 1.0%

Treatment:

Drug: VVN461 Ophthalmic Solution 1.0%

1.0% prednisolone acetate

Active Comparator group

Description:

1.0% prednisolone acetate, Pred Forte

Treatment:

Drug: 1.0% prednisolone acetate