Comparison of Conjunctival Antimicrobial Activity and Patient Comfort Between Topical Hypochlorous Acid (Avenova) and Betadine

NCT04981860 | Suspended Phase 4 FDA Drug

• 1 other identifier: 20200815
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this research study is to find out how Avenova (0.01 % hypochlorous acid) works compared to Betadine (Povidone iodide) for reducing bacteria and patient discomfort in the eyes.

Conditions

Eye Infections, Bacterial

Outcome Measures

Primary Outcomes (1)

• Number of bacterial Colony Forming Units (CFU)

  As assessed from sterile culture swab applied to the eye

  Day 1

Secondary Outcomes (1)

• Change in Post Exposure Symptom Severity Scale

  Baseline, Day 2

Study Arms (4)

Treatment naïve participants First Group L

EXPERIMENTAL

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

Drug: Betadine; Drug: Avenova

Treatment naïve participants Second Group R

EXPERIMENTAL

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

Drug: Betadine; Drug: Avenova

Participants undergoing intravitreal injection First Group L

EXPERIMENTAL

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.

Drug: Betadine; Drug: Avenova

Participants undergoing intravitreal injection Second Group R

EXPERIMENTAL

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.

Drug: Betadine; Drug: Avenova

Interventions

Betadine DRUG

One drop of 5% Betadine will be administered to the inferior conjunctiva of the eye

Also known as: Povidone Iodine

Participants undergoing intravitreal injection First Group L; Participants undergoing intravitreal injection Second Group R; Treatment naïve participants First Group L; Treatment naïve participants Second Group R

Avenova DRUG

One drop of 0.01% Avenova will be administered to the inferior conjunctiva of the left eye

Also known as: Hypochlorous Acid

Participants undergoing intravitreal injection First Group L; Participants undergoing intravitreal injection Second Group R; Treatment naïve participants First Group L; Treatment naïve participants Second Group R

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Treatment Naïve patients:
• \- Any patient who is able to give consent for the study and did not receive an intravitreal injection in the past 6 months
• Patients receiving injections:
• \- Patient currently undergoing treatment for which he/she receives a intravitreal injection in one eye.

You may not qualify if:

• Treatment Naïve patients:
• Intravitreal injections in the past 6 months
• Use of eye drops for treatment of glaucoma in the past 6 months
• Use of eye drops with antibiotics or steroids in the past 6 months
• Patients receiving injections:
• Patient receiving injections in both eyes
• Use of eye drops for treatment of glaucoma in the past 6 months
• Use of eye drops with antibiotics or steroids in the past 6 months
• Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.
• For both groups:
• Adults unable to consent
• Individuals who are not yet adults (infants, children, teenagers)
• Pregnant women
• Prisoners

Sponsors & Collaborators

• University of Miami: lead

Study Sites (2)

Bascom Palmer Eye Institute

Palm Beach Gardens, Florida, 33418, United States

Location

Medical Center Ophthalmology Associates

San Antonio, Texas, 78240, United States

Location

MeSH Terms

Conditions

Eye Infections, Bacterial

Interventions

Povidone-Iodine; Hypochlorous Acid

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Eye Infections; Eye Diseases

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Acids, Noncarboxylic; Acids; Chlorine Compounds; Reactive Oxygen Species; Free Radicals; Oxides; Oxygen Compounds

Study Officials

• Jorge Fortun, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: July 29, 2021
• Study Start: August 6, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)