NCT04568213

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 29, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

October 29, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2022

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

2.1 years

First QC Date

September 24, 2020

Last Update Submit

February 17, 2023

Conditions

CataractEndophthalmitis

Keywords

Ocular/Eyelid Flora

Outcome Measures

Primary Outcomes (2)

  • 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

    On day of surgery prior to surgical prep

  • 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

    On day of surgery prior to surgical prep

Study Arms (1)

Hypochlorous Gel Application

EXPERIMENTAL
Drug: Hypochlorous Acid Gel 0.02%

Interventions

Hypochlorous Acid Gel 0.02%DRUG

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.

Hypochlorous Gel Application

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Patients undergoing cataract surgery.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University Health

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

CataractEndophthalmitis

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesEye InfectionsInfections

Study Officials

  • Jeffrey J Ing, MD

    Loma Linda University Department of Ophthalmology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2020

First Posted

September 29, 2020

Study Start

October 29, 2020

Primary Completion

December 9, 2022

Study Completion

December 9, 2022

Last Updated

February 21, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)