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Antimicrobial Agent

Avenova vs Betadine for Bacterial Eye Infections

Phase 4

Recruiting

Led By Jorge Fortun, MD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients receiving injections: Patient currently undergoing treatment for which he/she receives an intravitreal injection in one eye.

Be older than 18 years old

Must not have

Treatment Naïve patients: Intravitreal injections in the past 6 months

Patients receiving injections: Patient receiving injections in both eyes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, day 2

Awards & highlights

Pivotal Trial

Approved for 5 Other Conditions

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial is testing Avenova vs Betadine to see which is more effective at reducing bacteria and patient discomfort in the eyes.

Who is the study for?

This trial is for patients who can consent and haven't had an eye injection in the last 6 months. It's suitable for those currently getting treatment that involves an eye injection.

What is being tested?

The study compares Avenova (0.01% hypochlorous acid) with Betadine (Povidone iodide) to see which is better at reducing bacteria and discomfort in patients with bacterial eye infections.

What are the potential side effects?

Possible side effects may include temporary irritation, stinging or burning sensation in the eyes after application of either Avenova or Betadine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am getting eye injections for treatment in one eye.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had any eye injections in the last 6 months.

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I am receiving injections in both of my eyes.

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I am an adult.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, day 2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, day 2

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, day 2 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of bacterial Colony Forming Units (CFU)

Secondary study objectives

Change in Post Exposure Symptom Severity Scale

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Treatment naïve participants Second Group RExperimental Treatment2 Interventions

Treatment naïve participants randomized to receive Avenova on the left eye and Betadine on the right Eye

Group II: Treatment naïve participants First Group LExperimental Treatment2 Interventions

Treatment naïve participants randomized to receive Betadine on the left eye and Avenova on the right Eye

Group III: Participants undergoing intravitreal injection Second Group RExperimental Treatment2 Interventions

Participants undergoing intravitreal injection will receive betadine in the eye that is receiving injections and Avenova in the other eye. Group R are patients that are having intravitreal injections and will receive betadine in the right eye and Avenova in the left eye.

Group IV: Participants undergoing intravitreal injection First Group LExperimental Treatment2 Interventions

Participants undergoing intravitreal injection will receive betadine in the eye that is receiving injections and Avenova in the other eye. Group L are patients that are having intravitreal injections and will receive betadine in the left eye and Avenova in the right eye.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hypochlorous acid

Not yet FDA approved

Povidone-iodine

FDA approved

0 / 4Eligibility criteria met