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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 2
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am getting eye injections for treatment in one eye.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of bacterial Colony Forming Units (CFU)
Secondary outcome measures
Change in Post Exposure Symptom Severity Scale

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

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
899 Previous Clinical Trials
409,507 Total Patients Enrolled
Jorge Fortun, MDPrincipal Investigator - University of Miami
University Of Michigan Medical Sch (Medical School)
Baylor College Of Medicine (Residency)

Media Library

Avenova (Antimicrobial Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04981860 — Phase 4
Bacterial Eye Infections Research Study Groups: Participants undergoing intravitreal injection Second Group R, Treatment naïve participants First Group L, Treatment naïve participants Second Group R, Participants undergoing intravitreal injection First Group L
Bacterial Eye Infections Clinical Trial 2023: Avenova Highlights & Side Effects. Trial Name: NCT04981860 — Phase 4
Avenova (Antimicrobial Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04981860 — Phase 4

Frequently Asked Questions

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

In what medical scenarios is Betadine commonly employed?

"Betadine is typically used for disinfection but can also be utilized to address periocular region preparation, abrasions, and irrigation needs."

Answered by AI

Are there any concomitant investigations that have probed Betadine?

"Betadine was initially investigated at Anaheim Crest Nursing Center in 2017, and since then 70 trials have been successfully completed. There are now 10 live studies actively taking place, many of which originate from San Antonio, Texas."

Answered by AI

What regulatory approval has Betadine received?

"Thanks to the fact that Betadine has passed Phase 4 clinical trials, our team of experts assigned it a score of 3 for safety."

Answered by AI

How many individuals are being administered treatments as part of this experiment?

"The evidence on clinicaltrials.gov indicates that this research is actively recruiting; the listing was first published on August 6th 2021 and recently refreshed on August 2nd 2022. To complete the study, 230 participants must be enrolled from two distinct medical facilities."

Answered by AI

Are volunteers currently being sought for this research endeavor?

"Yes, clinicaltrials.gov reveals that this clinical trial is actively enlisting participants. The study was initially posted on August 6th 2021 and recently modified on August 2nd 2022; 230 individuals are needed to be recruited across two medical facilities."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Comparison of Conjunctival Antimicrobial Activity and Patient Comfort Between Topical Hypochlorous Acid (Avenova) and Betadine
Jorge Fortun 2021. "Comparison of Conjunctival Antimicrobial Activity and Patient Comfort Between Topical Hypochlorous Acid (Avenova) and Betadine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04981860.
~41 spots leftby Dec 2024
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