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

Phase 2

Recruiting

• Conditions: Anterior Uveitis
• Interventions: Drug: VVN461 Ophthalmic Solution 1.0%; Drug: VVN461 Ophthalmic Solution 0.5%; Drug: Prednisolone acetate

• Registration Number: NCT06679153
• Lead Sponsor: VivaVision Biotech, Inc

Brief 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.

Study Timeline

• Study Start: 2023-11-27
• Status Verified: 2024-11
• Study First Submitted: 2024-11-05
• Study First Submitted QC: 2024-11-05
• Study First Posted: 2024-11-07
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-11
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

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Exclusion Criteria

• Diagnosis of intermediate uveitis, posterior uveitis or panuveitis in either eye at the time of screening

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VVN461, 1.0%	VVN461 Ophthalmic Solution 1.0%	VVN461 Ophthalmic Solution, 1.0%
VVN461, 0.5%	VVN461 Ophthalmic Solution 0.5%	VVN461 Ophthalmic Solution, 0.5%
Prednisolone acetate, 1%	Prednisolone acetate	Prednisolone acetate Ophthalmic Solution, 1%

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
ACC score of 0	Baseline to Day 28	Proportion of subjects with an ACC score of 0 at any visit