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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-27

Study Completion Date

2024-12-29

Brief Summary

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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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Detailed Description

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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

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Anterior Uveitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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VVN461, 1.0%

VVN461 Ophthalmic Solution, 1.0%

Group Type EXPERIMENTAL

VVN461 Ophthalmic Solution 1.0%

Intervention Type DRUG

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

VVN461, 0.5%

VVN461 Ophthalmic Solution, 0.5%

Group Type EXPERIMENTAL

VVN461 Ophthalmic Solution 0.5%

Intervention Type DRUG

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

Prednisolone acetate, 1%

Prednisolone acetate Ophthalmic Solution, 1%

Group Type PLACEBO_COMPARATOR

Prednisolone acetate

Intervention Type DRUG

Prednisolone acetate, 1%, for up to 28 days

Interventions

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VVN461 Ophthalmic Solution 1.0%

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

Intervention Type DRUG

VVN461 Ophthalmic Solution 0.5%

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

Intervention Type DRUG

Prednisolone acetate

Prednisolone acetate, 1%, for up to 28 days

Intervention Type DRUG

Other Intervention Names

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Pred Forte

Eligibility Criteria

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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