Hypochlorous Acid Disinfection Prior to Cataract Surgery

February 17, 2023 updated by: Loma Linda University

Effect of Hypochlorous Acid Disinfection on Ocular Flora Prior to Cataract Surgery

Antibiotics are commonly utilized to reduce the bacterial population of the eye prior to surgery with the assumption that this reduces the risk of endophthalmitis, although it is not clear if this actually occurs. This study will investigate the use of Hypochlorous Acid, a commercially available over the counter (OTC) medication to see if this will reduce the bacterial population prior the cataract surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Patients undergoing cataract surgery.

Exclusion Criteria:

  • Age <18 years old
  • Vulnerable subjects
  • Non-English Speakers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hypochlorous Gel Application
Drug: Hypochlorous Acid Gel 0.02%
0.02% Hypochlorous Acid Gel (OCusoft Hypochlor GEL) will be sprayed onto the closed eyelid of the surgical eye while covering the fellow eye with palm of the hand, left for 60 seconds, then wiped off with a clean gauze, tissue, or cotton ball.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in bacterial flora in eyelashes of treatment eye compared to fellow eye
Time Frame: On day of surgery prior to surgical prep
Swab will be used to obtain samples from the eyelashes bilaterally and cultured
On day of surgery prior to surgical prep
Reduction in bacterial flora in conjunctiva of treatment eye compared to fellow
Time Frame: On day of surgery prior to surgical prep
Swab will be used to obtain samples from the conjunctiva bilaterally and cultured
On day of surgery prior to surgical prep

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loma Linda University

Investigators

  • Principal Investigator: Jeffrey J Ing, MD, Loma Linda University Department of Ophthalmology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2020

Primary Completion (Actual)

December 9, 2022

Study Completion (Actual)

December 9, 2022

Study Registration Dates

First Submitted

September 24, 2020

First Submitted That Met QC Criteria

September 24, 2020

First Posted (Actual)

September 29, 2020

Study Record Updates

Last Update Posted (Estimate)

February 20, 2023

Last Update Submitted That Met QC Criteria

February 17, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5200306

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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