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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clear ocular media (other than cataract) in the study eye
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 21
Awards & highlights
Summary
This trial is being conducted at multiple locations in the US. It is a study that involves patients who are getting surgery to remove cataracts and replace their lenses. The study compares the effects of different
Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Possible side effects of VVN461 may include discomfort or irritation in the eye, redness, dryness, or blurred vision post-application. These are common reactions when using ophthalmic solutions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My study eye is clear of any issues except for cataracts.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 21
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 21
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Anterior chamber cell: Categorical cure
Secondary study objectives
Safety of VVN461
Trial Design
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VVN461 Ophthalmic Solution 0.5%
2024
Completed Phase 2
~100
VVN461 Ophthalmic Solution 1.0%
2024
Completed Phase 2
~100
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Who is running the clinical trial?
VivaVision Biotech, IncLead Sponsor
3 Previous Clinical Trials
937 Total Patients Enrolled
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