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VVN461 0.5% for Inflammation

Phase 2
Recruiting
Research Sponsored by VivaVision Biotech, Inc
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

Study 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.Check my eligibility
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.See study design
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 below
Select...
My study eye is clear of any issues except for cataracts.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 21
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 21 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Anterior chamber cell: Categorical cure
Secondary outcome measures
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

Find a Location

Who is running the clinical trial?

VivaVision Biotech, IncLead Sponsor
3 Previous Clinical Trials
937 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many medical institutions is this clinical examination currently being conducted?

"This trial is being conducted at the Cincinnati Eye Institute in Cincinnati, Ohio, as well as the United Medical Research Institute in Inglewood, California, and North Bay Eye Associates in Petaluma, Colorado. Additionally, there are 9 other locations where this trial will take place."

Answered by AI

What is the current number of individuals who have been granted admission to participate in this clinical study?

"To proceed with the study, we need a total of 90 eligible participants who meet the trial's inclusion criteria. The sponsor, VivaVision Biotech, Inc., will be overseeing the trial across various locations including Cincinnati Eye Institute in Cincinnati, Ohio and United Medical Research Institute in Inglewood, California."

Answered by AI

What are the potential risks and hazards associated with the usage of VVN461 1.0% by individuals?

"Based on our assessment, the safety rating for VVN461 1.0% is a 2 as per Power's scale. This determination is due to it being in Phase 2 of the trial, where some data supports its safety but there is no evidence yet regarding efficacy."

Answered by AI

Are there any open slots available for new patients to participate in this research study at the moment?

"Indeed, the details presented on clinicaltrials.gov confirm that this trial is actively seeking eligible candidates. The initial posting took place on January 1st, 2024 and was most recently edited on December 19th, 2023. To complete the study successfully, a total of 90 participants will be recruited from nine different sites."

Answered by AI

Who else is applying?

What site did they apply to?
Martel Eye Associates
Keystone Research
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

I am planning on having cataract sometime this spring/summer 2024. If these drops help prevent inflammation post op that would be a plus.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Phase 2: VVN461 Ophthalmic Solution for Post -Operative Ocular Inflammation After Cataract Surgery
2024. "Phase 2: VVN461 Ophthalmic Solution for Post -Operative Ocular Inflammation After Cataract Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06164743.
All > Montreal > Cataract
~57 spots leftby Dec 2024
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