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Completed

NCT Number: NCT06679153

A Phase 2 Study of VVN461 Ophthalmic Solution for Noninfectious Anterior Uveitis

This is a multicenter, double-masked, randomized, active-controlled, parallel-comparison study conducted at sites in the China in subjects with Noninfectious Anterior Uveitis

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Key information

Conditions

Anterior Uveitis Eye Diseases Panuveitis Uveal Diseases Uveitis Uveitis, Anterior

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peking University First Hospital

Beijing, China

About this study

In this study, subjects who meet the inclusion/exclusion criteria will be randomized to receive one of the three treatments prednisolone acetate during the Screening/Baseline Visit (Day-2 to Day 1). Starting from Visit 1 (Day 1), subjects will be administered one drop of the investigational product in the study eye in following dose regimens: 6 times per day (Q2h, 2 hours apart) for 7 days; 4 times per day (QID) for 7 days；2 times per day (BID) for 7 days；once a day (QD) for 7 days. Subjects will return to clinic for study assessments on Day 3 (Visit 2), Day 7 (Visit 3), Day 14 (Visit 4), Day 21 (Visit 5) and Day 28 (Visit 6, end of study) or early withdrawal/termination visit.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18-70 years at the time providing signed informed consent
  • At least 1 eye diagnosed with noninfectious anterior uveitis at the time of screening
  • Willing and able to comply with study requirements and visit schedule

Exclusion criteria

  • 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

VVN461 Ophthalmic Solution, 1.0%, for up to 28 days

VVN461 Ophthalmic Solution 0.5%

Drug

VVN461 Ophthalmic Solution, 0.5%, for up to 28 days

Prednisolone Acetate

Drug

Prednisolone acetate, 1%, for up to 28 days

Other names: Pred Forte

Primary outcomes

  1. ACC score of ≥2 grade from baseline at Day 14

    Time frame: Day 14

    Proportion of subjects with improvement in ACC score of ≥2 grade from baseline at Day 14

Secondary outcomes

  1. ACC score of 0

    Time frame: Baseline to Day 28

    Proportion of subjects with an ACC score of 0 at any visit

Sponsors and collaborators

Lead sponsor

VivaVision Biotech, Inc

Industry

Registry information

Official study title

A Randomized, Double-masked, Active-controlled, Multi-center Phase 2 Clinical Study Evaluating the Efficacy and Safety of 0.5% and 1.0% VVN461 Ophthalmic Solution in Patients With Noninfectious Anterior Uveitis

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 7, 2024
Registry last updated
Jan 27, 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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