NCT06679153

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: VivaVision Biotech, Inc · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Anterior Uveitis

Interventions

Type	Name	Description
DRUG	VVN461 Ophthalmic Solution 1.0%	VVN461 Ophthalmic Solution, 1.0%, for up to 28 days
DRUG	VVN461 Ophthalmic Solution 0.5%	VVN461 Ophthalmic Solution, 0.5%, for up to 28 days
DRUG	Prednisolone acetate	Prednisolone acetate, 1%, for up to 28 days

Timeline

• Start date: 2023-11-27
• Primary completion: 2024-12-29
• Completion: 2024-12-29
• First posted: 2024-11-07
• Last updated: 2025-01-27

Locations

1 site across 1 country: China