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

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

Study Overview

• Status: Completed
• Conditions: Anterior Uveitis
• Intervention / Treatment: Drug: VVN461 Ophthalmic Solution 1.0%; Drug: VVN461 Ophthalmic Solution 0.5%; Drug: Prednisolone acetate

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 Type: Interventional
• Enrollment (Actual): 89
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking University First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VVN461, 1.0%; VVN461 Ophthalmic Solution, 1.0%	Drug: VVN461 Ophthalmic Solution 1.0%; VVN461 Ophthalmic Solution, 1.0%, for up to 28 days
Experimental: VVN461, 0.5%; VVN461 Ophthalmic Solution, 0.5%	Drug: VVN461 Ophthalmic Solution 0.5%; VVN461 Ophthalmic Solution, 0.5%, for up to 28 days
Placebo Comparator: Prednisolone acetate, 1%; Prednisolone acetate Ophthalmic Solution, 1%	Drug: Prednisolone acetate; Prednisolone acetate, 1%, for up to 28 days; Other Names: Pred Forte

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ACC score of ≥2 grade from baseline at Day 14	Proportion of subjects with improvement in ACC score of ≥2 grade from baseline at Day 14	Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ACC score of 0	Proportion of subjects with an ACC score of 0 at any visit	Baseline to Day 28

Collaborators and Investigators

• Sponsor: VivaVision Biotech, Inc

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2023
• Primary Completion (Actual): December 29, 2024
• Study Completion (Actual): December 29, 2024

Study Registration Dates

• First Submitted: November 5, 2024
• First Submitted That Met QC Criteria: November 5, 2024
• First Posted (Actual): November 7, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 24, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Uveal Diseases; Panuveitis; Iris Diseases; Uveitis; Uveitis, Anterior; Iridocyclitis; Antineoplastic Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protective Agents; Neuroprotective Agents; Methylprednisolone Acetate; Prednisolone; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: VVN461-CCS-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No