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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorVivaVision Biotech, Inc

About this trial

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

Eligibility criteria

Qualifiers

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

Treatments tested in this trial

  • VVN461 Ophthalmic Solution 1.0%
  • 1.0% prednisolone acetate

Treatment groups

152 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators