0.01% Hypochlorous Acid in the Treatment of Blepharitis

November 4, 2022 updated by: Eye & ENT Hospital of Fudan University

Effect of Hypochlorous Acid on Blepharitis Through Ultrasonic Atomization: a Randomized Clinical Trial

This is a multi-center, multidisciplinary, open-label, randomized controlled prospective clinical study.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Eye & ENT Hospital of Fudan University
        • Contact:
        • Principal Investigator:
          • Hong Zhang, MsC
        • Principal Investigator:
          • Yuqing Wu, MsC

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18 or older.
  2. Anterior or mixed (anterior + posterior) blepharitis.
  3. Similar clinical condition of both eyes.
  4. A negative urine pregnancy test result for women of childbearing potential
  5. Normal lid position and closure
  6. Ability to understand and provide informed consent to participate in this study
  7. Willingness to follow study instructions and likely to complete all required visits.

Exclusion Criteria:

  1. Any ocular surface disease other than blepharitis.
  2. Known allergy to hypochlorous acid or boric acid.
  3. Eye surgery in the last 6 months.
  4. History of Stevens-Johnson syndrome or ocular pemphigoid
  5. Ocular trauma in the last 6 months.
  6. Use of contact lenses in the last 6 months.
  7. Pregnancy or lactation.
  8. Daily use of makeup on lashes.
  9. Any ocular or systemic medication that might affect the ocular microbiota (antibiotics, immunosuppressants, steroids).
  10. Pregnant or lactating women
  11. Signs of current infection, including fever and current treatment with antibiotics
  12. Liver, renal, or hematologic disease
  13. The use of any other investigational drug

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment arm
0.01%hypochlorous acid group
Drug: 0.01% hypochlorous acid
once daily 0.01% hypochlorous acid topical treatment via ultrasonic atomization for 2 weeks
Other Names:
  • 0.01%HOCI
Placebo Comparator: Placebo
eyelid wipes
Drug: Placebo
once daily eyelid wipes for 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OSDI
Time Frame: Change from baseline OSDI at 2 weeks
0-100 score based on the ocular surface disease index (OSDI) questionnaire
Change from baseline OSDI at 2 weeks
meibum quality
Time Frame: Change from baseline meibum quality score at 2 weeks
Meibum quality were measured by using firm digital pressure applied over 5 lower lid glands. Meibum quality was graded as: grade 0, clear; grade 1, cloudy; grade 2, cloudy with granular debris; and grade 3, thick like toothpaste.
Change from baseline meibum quality score at 2 weeks
Corneal fluorescein staining
Time Frame: Change from baseline corneal fluorescein staining at 2 weeks
scored by Oxford staining score
Change from baseline corneal fluorescein staining at 2 weeks
FBUT
Time Frame: Change from baseline FTBUT at 2 weeks
fluorescent tear break up time fluorescein tear film break-up time
Change from baseline FTBUT at 2 weeks

Collaborators and Investigators

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

Sponsor

Eye & ENT Hospital of Fudan University

Collaborators

ShuGuang Hospital

Investigators

  • Principal Investigator: Jiaxu Hong, Eye & ENT Hospital of Fudan University

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)

July 1, 2022

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

October 27, 2022

First Submitted That Met QC Criteria

November 4, 2022

First Posted (Actual)

November 8, 2022

Study Record Updates

Last Update Posted (Actual)

November 8, 2022

Last Update Submitted That Met QC Criteria

November 4, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0.01% Hypochlorous Acid

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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