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

Primary Purpose

Eye Infections, Bacterial

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Betadine
Avenova
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eye Infections, Bacterial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion criteria:

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.

Exclusion Criteria:

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

Sites / Locations

  • Bascom Palmer Eye InstituteRecruiting
  • Medical Center Ophthalmology AssociatesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Treatment naïve participants First Group L

Treatment naïve participants Second Group R

Participants undergoing intravitreal injection First Group L

Participants undergoing intravitreal injection Second Group R

Arm Description

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

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

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.

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.

Outcomes

Primary Outcome Measures

Number of bacterial Colony Forming Units (CFU)
As assessed from sterile culture swab applied to the eye

Secondary Outcome Measures

Change in Post Exposure Symptom Severity Scale
The Post exposure questionnaire has a total score ranging from 1 to 10 with a higher score indicating greater pain

Full Information

First Posted
July 27, 2021
Last Updated
July 13, 2023
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT04981860
Brief Title
Comparison of Conjunctival Antimicrobial Activity and Patient Comfort Between Topical Hypochlorous Acid (Avenova) and Betadine
Official Title
Comparison of Conjunctival Antimicrobial Activity and Patient Comfort Between Topical Hypochlorous Acid (Avenova) and Betadine
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 6, 2021 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
About two percent of the population have an iodine allergy 1. A percentage of this population will also have a reaction to iodine-containing agents, including povidone iodine (PI) (Betadine®), which is the current standard of care for anti-septic preparation for conjunctival procedures. Despite being known to have a toxic effect on the cornea 2 and causing allergic reactions in some individuals, povidone Iodine (PI) (Betadine®) is still the most commonly used antiseptic agent for surgical scrub. Currently, there are no equivalent alternative prep agents available, although chlorhexidine has occasionally served as an alternative to povidone iodine (PI) (Betadine®) with variable results 2. Some studies have reported significantly less pain in patients prepped with chlorhexidine compared to povidone iodine (PI) (Betadine®) 2, and other studies have demonstrated that chlorhexidine has equal efficacy to povidone iodine (PI)(Betadine®) in decreasing the colony forming units of microbes both in vitro and in vivo 3. Although there have been no known reported allergies to chlorhexidine, it is known to be toxic to the cornea (leading to severe keratitis) and has proven to be less effective against MRSA 4. The use of 0.01% hypochlorous acid (HOCl) in saline solution as an antiseptic agent has been gaining popularity as a possible alternative to povidone iodine (PI) (Betadine®). Hypochlorous acid (HOCl) is produced in vivo by neutrophils and causes oxidation of microbial nucleotides and inactivation of microbial enzymes, leading to cell death. Hypochlorous acid (HOCl) has a faster optimal kill-time for flora common to the eye 4, and has proven to be non-cytotoxic and well tolerated for continuous use 4,5,6. In vitro studies of 0.01% hypochlorous acid (HOCl) were found to have equal or more efficacious antiseptic properties compared with povidone iodine (PI) (Betadine®) and other potential antiseptic agents including chlorohexidine and isopropyl alcohol 4. Currently, two concentrations of HOCl are available for commercial use: AvenovaTM with Neutrox™ (0.01% HOCl) and an over the counter product (0.02% HOCl). Both concentrations are used to treat blepharitis. Debabov et al5 presented toxicity data concluding that 0.01% hypochlorous acid (HOCl) (Avenova™ with Neutrox™) proved to be non-cytotoxic in comparison to the 0.02% hypochlorous acid (HOCl) product which was cytotoxic thus supporting the potential benefit of HOCl. Stroman et al6 2017 concludes that hypochlorous acid (HOCl)in saline solution reduced bacterial colony load significantly without altering the variation of remaining bacterial species. Additionally, hypochlorous acid (HOCl) has been shown to reduce the population of bacterial and fungal species common to the lids and lashes by ≥ 99.9% 7. Despite the use of hypochlorous acid (HOCl) as a topical antiseptic on the eyelid, there have been no reports of its use as an antiseptic agent for conjunctival procedures. Many studies have confirmed that flora of the eyelid and eyelash only differ in their concentrations 8. Since hypochlorous acid (HOCl) has been found to be effective in reducing colony forming units and since the flora species of the conjunctiva, eyelid and eyelashes are equivalent, we propose that hypochlorous acid (HOCl) may serve as an alternative to povidone iodine (PI) (Betadine®) as a conjunctival procedure prep agent. Considering there were no reported negative side effects of hypochlorous acid (HOCl) contact with the eye, hypochlorous acid (HOCl) may prove to be a non-inferior alternative to povidone iodine (PI) (Betadine®). This may result in lower irritation and toxicity compared to povidone iodine (PI) (Betadine®)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eye Infections, Bacterial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
230 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment naïve participants First Group L
Arm Type
Experimental
Arm Description
Treatment naïve participants randomized to receive Betadine on the left eye and Avenova on the right Eye
Arm Title
Treatment naïve participants Second Group R
Arm Type
Experimental
Arm Description
Treatment naïve participants randomized to receive Avenova on the left eye and Betadine on the right Eye
Arm Title
Participants undergoing intravitreal injection First Group L
Arm Type
Experimental
Arm Description
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.
Arm Title
Participants undergoing intravitreal injection Second Group R
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Betadine
Other Intervention Name(s)
Povidone Iodine
Intervention Description
One drop of 5% Betadine will be administered to the inferior conjunctiva of the eye
Intervention Type
Drug
Intervention Name(s)
Avenova
Other Intervention Name(s)
Hypochlorous Acid
Intervention Description
One drop of 0.01% Avenova will be administered to the inferior conjunctiva of the left eye
Primary Outcome Measure Information:
Title
Number of bacterial Colony Forming Units (CFU)
Description
As assessed from sterile culture swab applied to the eye
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Change in Post Exposure Symptom Severity Scale
Description
The Post exposure questionnaire has a total score ranging from 1 to 10 with a higher score indicating greater pain
Time Frame
Baseline, Day 2

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marilyn Marquez, MD
Phone
919-943-2314
Email
mam8757@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge Fortun, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bascom Palmer Eye Institute
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33418
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge Fortun, MD
Phone
561-515-1543
Email
jfortun@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Jorge Fortun, MD
Facility Name
Medical Center Ophthalmology Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Singer, MD
Phone
210-697-2020
Email
msinger11@me.com
First Name & Middle Initial & Last Name & Degree
Michael Singer, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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