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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • VVN461 Ophthalmic Solution 1.0%

    Drug

    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

    Drug

    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

Treatment groups

152 Participants
are divided into 2 treatment groups
Group A: VVN461, 1.0%Experimental treatment 1 intervention
Group B: 1.0% prednisolone acetateActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in anterior chamber cell (ACC) grade in the study eye at Day 14

Time frame
Day 14

Secondary outcomes

1

The proportion of subjects with ACC grade of 0 in the study eye at Day 14

Time frame
Day 14

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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