search
Back to results

Hypochlorous Acid Disinfection Prior to Cataract Surgery

Primary Purpose

Cataract, Endophthalmitis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Hypochlorous Acid Gel 0.02%
Sponsored by
Loma Linda University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cataract focused on measuring Ocular/Eyelid Flora

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Patients undergoing cataract surgery.

Exclusion Criteria:

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

Sites / Locations

  • Loma Linda University Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hypochlorous Gel Application

Arm Description

Outcomes

Primary Outcome Measures

Reduction in bacterial flora in eyelashes of treatment eye compared to fellow eye
Swab will be used to obtain samples from the eyelashes bilaterally and cultured
Reduction in bacterial flora in conjunctiva of treatment eye compared to fellow
Swab will be used to obtain samples from the conjunctiva bilaterally and cultured

Secondary Outcome Measures

Full Information

First Posted
September 24, 2020
Last Updated
February 17, 2023
Sponsor
Loma Linda University
search

1. Study Identification

Unique Protocol Identification Number
NCT04568213
Brief Title
Hypochlorous Acid Disinfection Prior to Cataract Surgery
Official Title
Effect of Hypochlorous Acid Disinfection on Ocular Flora Prior to Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 29, 2020 (Actual)
Primary Completion Date
December 9, 2022 (Actual)
Study Completion Date
December 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loma Linda University

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.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Endophthalmitis
Keywords
Ocular/Eyelid Flora

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hypochlorous Gel Application
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Hypochlorous Acid Gel 0.02%
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction in bacterial flora in eyelashes of treatment eye compared to fellow eye
Description
Swab will be used to obtain samples from the eyelashes bilaterally and cultured
Time Frame
On day of surgery prior to surgical prep
Title
Reduction in bacterial flora in conjunctiva of treatment eye compared to fellow
Description
Swab will be used to obtain samples from the conjunctiva bilaterally and cultured
Time Frame
On day of surgery prior to surgical prep

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Patients undergoing cataract surgery. Exclusion Criteria: Age <18 years old Vulnerable subjects Non-English Speakers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey J Ing, MD
Organizational Affiliation
Loma Linda University Department of Ophthalmology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University Health
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Hypochlorous Acid Disinfection Prior to Cataract Surgery

We'll reach out to this number within 24 hrs