Phase 2: VVN461 Ophthalmic Solution for Post -Operative Ocular Inflammation After Cataract Surgery

Recruiting in Palo Alto (17 mi)

+9 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: VivaVision Biotech, Inc

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is a multicenter, double-masked, randomized, vehicle-controlled, parallel-comparison study conducted at sites in the United States (US) in subjects undergoing routine unilateral cataract extraction and lens replacement (CELR) surgery via phacoemulsification

Research Team

Eligibility Criteria

This trial is for adults over 21 in good health who are planning to have routine cataract surgery via phacoemulsification. Participants must be able to consent, have clear vision media (aside from the cataract), and follow the study's schedule.

Inclusion Criteria

I am 21 or older and in good health.

You are willing to understand and agree to participate in the study, and give permission for your information to be used.

My study eye is clear of any issues except for cataracts.

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Treatment Details

Interventions

VVN461 Ophthalmic Solution (Corticosteroid)

Trial OverviewThe study tests two strengths of VVN461 Ophthalmic Solution (1.0% and 0.5%) against a placebo, called 'vehicle', to see if they reduce inflammation after cataract surgery. It's a double-masked, randomized comparison at multiple US centers.

Participant Groups

3Treatment groups

Experimental Treatment

Placebo Group

Group I: VVN461 1.0%Experimental Treatment1 Intervention

VVN461 Ophthalmic Solution, 1.0%

Group II: VVN461 0.5%Experimental Treatment1 Intervention

VVN461 Ophthalmic Solution, 0.5%

Group III: VehiclePlacebo Group1 Intervention

VVN461 Vehicle