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

VivaVision Biotech

Status and phase: Completed; Phase 2

Conditions: Anterior Uveitis

Treatments: Drug: Prednisolone acetate; Drug: VVN461 Ophthalmic Solution 1.0%; Drug: VVN461 Ophthalmic Solution 0.5%

Study type: Interventional

Funder types: Industry

Identifiers

NCT06679153

VVN461-CCS-201

Details and patient eligibility

About

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

Full 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.

Enrollment: 89 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

89 participants in 3 patient groups, including a placebo group

VVN461, 1.0%

Experimental group

Description:

VVN461 Ophthalmic Solution, 1.0%

Treatment:

Drug: VVN461 Ophthalmic Solution 1.0%

VVN461, 0.5%

Experimental group

Description:

VVN461 Ophthalmic Solution, 0.5%

Treatment:

Drug: VVN461 Ophthalmic Solution 0.5%

Prednisolone acetate, 1%

Placebo Comparator group

Description:

Prednisolone acetate Ophthalmic Solution, 1%

Treatment:

Drug: Prednisolone acetate