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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
This is a multicenter, double-masked, randomized, active-controlled, parallel-comparison study conducted at sites in the China in subjects with Noninfectious Anterior Uveitis
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.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
Peking University First Hospital
Beijing, China
Start Date
November 27, 2023
Primary Completion Date
December 29, 2024
Completion Date
December 29, 2024
Last Updated
January 27, 2025
89
ACTUAL participants
VVN461 Ophthalmic Solution 1.0%
DRUG
VVN461 Ophthalmic Solution 0.5%
DRUG
Prednisolone acetate
DRUG
Lead Sponsor
VivaVision Biotech, Inc
NCT03586284
NCT07285070
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04222712