Hypochlorous Acid Disinfection Prior to Cataract Surgery
Sponsor
Loma Linda University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04568213
Collaborator
(none)
55
1
1
25.1
2.2
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
55 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Effect of Hypochlorous Acid Disinfection on Ocular Flora Prior to Cataract Surgery
Actual Study Start Date
:
Oct 29, 2020
Anticipated Primary Completion Date
:
Dec 1, 2022
Anticipated Study Completion Date
:
Dec 1, 2022
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Reduction in bacterial flora in eyelashes of treatment eye compared to fellow eye [On day of surgery prior to surgical prep]
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 [On day of surgery prior to surgical prep]
Swab will be used to obtain samples from the conjunctiva bilaterally and cultured
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 95 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Patients undergoing cataract surgery.
Exclusion Criteria:
-
Age <18 years old
-
Vulnerable subjects
-
Non-English Speakers
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Loma Linda University Health | Loma Linda | California | United States | 92354 |
Sponsors and Collaborators
- Loma Linda University
Investigators
- Principal Investigator: Jeffrey J Ing, MD, Loma Linda University Department of Ophthalmology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Loma Linda University
ClinicalTrials.gov Identifier:
NCT04568213
Other Study ID Numbers:
- 5200306
First Posted:
Sep 29, 2020
Last Update Posted:
Jun 16, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Loma Linda University
Additional relevant MeSH terms: