A Phase 3 Study of VVN461 Ophthalmic Solution for Noninfectious Anterior Uveitis

NCT07136805 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: VVN461-CCS-301
• Study Type: interventional
• Target: 152
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multicenter, randomized, single-masked, active-controlled, parallel, Phase III pivotal study in China

Conditions

Non-infectious Anterior Uveitis

Outcome Measures

Primary Outcomes (1)

• Change from baseline in anterior chamber cell (ACC) grade in the study eye at Day 14

  Day 14

Secondary Outcomes (1)

• The proportion of subjects with ACC grade of 0 in the study eye at Day 14

  Day 14

Study Arms (2)

VVN461, 1.0%

EXPERIMENTAL

VVN461 Ophthalmic Solution, 1.0%

Drug: VVN461 Ophthalmic Solution 1.0%

1.0% prednisolone acetate

ACTIVE COMPARATOR

1.0% prednisolone acetate, Pred Forte

Drug: 1.0% prednisolone acetate

Interventions

VVN461 Ophthalmic Solution 1.0% DRUG

1 drop for study eye each time, 6 times daily (Q2h) for 7 days; 4 times daily (QID) for 7 days; 2 times daily (BID) for 7 days; 1 time daily for 7 days

VVN461, 1.0%

1.0% prednisolone acetate DRUG

1 drop for study eye each time, 6 times daily (Q2h) for 7 days; 4 times daily (QID) for 7 days; 2 times daily (BID) for 7 days; 1 time daily for 7 days

1.0% prednisolone acetate

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At the time of signing the informed consent form (ICF), the subject must be aged 18 to 70 years (inclusive);
• At screening, the affected eye is diagnosed with non-infectious anterior uveitis (acute or recurrent acute, only unilateral eye affected patients are included);
• At screening, the ACC grade of the affected eye is 2+ or 3+ \[SUN criteria\];
• At screening, the ACF grade of the affected eye is ≥1 \[SUN criteria\];

You may not qualify if:

• At screening, the affected eye has an ACC grade of 4+ or hypopyon
• Diagnosis of intermediate uveitis, posterior uveitis, or panuveitis in either eye at the time of screening

Sponsors & Collaborators

• VivaVision Biotech, Inc: lead

MeSH Terms

Interventions

prednisolone acetate

Central Study Contacts

Caroline Lu

CONTACT

+8618816562189; caroline.lu@vivavisionbio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: August 22, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share