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NCT Number: NCT07136805

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

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

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Key information

Conditions

Non-infectious Anterior Uveitis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline Lu

CONTACT

[email protected]

+8618816562189

Sponsors and collaborators

Lead sponsor

VivaVision Biotech, Inc

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 22, 2025
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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