Back to results0.01% Hypochlorous Acid in the Treatment of Blepharitis
Primary Purpose
Blepharitis
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
0.01% hypochlorous acid
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Blepharitis focused on measuring Blepharitis, Hypochlorous Acid, Eyelid cleanser, Eyelid hygiene, Meibomian gland dysfunction
Eligibility Criteria
Inclusion Criteria: Age 18 or older. Anterior or mixed (anterior + posterior) blepharitis. Similar clinical condition of both eyes. A negative urine pregnancy test result for women of childbearing potential Normal lid position and closure Ability to understand and provide informed consent to participate in this study Willingness to follow study instructions and likely to complete all required visits. Exclusion Criteria: Any ocular surface disease other than blepharitis. Known allergy to hypochlorous acid or boric acid. Eye surgery in the last 6 months. History of Stevens-Johnson syndrome or ocular pemphigoid Ocular trauma in the last 6 months. Use of contact lenses in the last 6 months. Pregnancy or lactation. Daily use of makeup on lashes. Any ocular or systemic medication that might affect the ocular microbiota (antibiotics, immunosuppressants, steroids). Pregnant or lactating women Signs of current infection, including fever and current treatment with antibiotics Liver, renal, or hematologic disease The use of any other investigational drug
Sites / Locations
- Eye & ENT Hospital of Fudan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Treatment arm
Placebo
Arm Description
0.01%hypochlorous acid group
eyelid wipes
Outcomes
Primary Outcome Measures
OSDI
0-100 score based on the ocular surface disease index (OSDI) questionnaire
meibum quality
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.
Corneal fluorescein staining
scored by Oxford staining score
FBUT
fluorescent tear break up time fluorescein tear film break-up time
Secondary Outcome Measures
Full Information
NCT ID
NCT05608980
First Posted
October 27, 2022
Last Updated
November 4, 2022
Sponsor
Eye & ENT Hospital of Fudan University
Collaborators
ShuGuang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05608980
Brief Title
0.01% Hypochlorous Acid in the Treatment of Blepharitis
Official Title
Effect of Hypochlorous Acid on Blepharitis Through Ultrasonic Atomization: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
May 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eye & ENT Hospital of Fudan University
Collaborators
ShuGuang Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a multi-center, multidisciplinary, open-label, randomized controlled prospective clinical study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blepharitis
Keywords
Blepharitis, Hypochlorous Acid, Eyelid cleanser, Eyelid hygiene, Meibomian gland dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective, controlled, randomized study.
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment arm
Arm Type
Active Comparator
Arm Description
0.01%hypochlorous acid group
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
eyelid wipes
Intervention Type
Drug
Intervention Name(s)
0.01% hypochlorous acid
Other Intervention Name(s)
0.01%HOCI
Intervention Description
once daily 0.01% hypochlorous acid topical treatment via ultrasonic atomization for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
once daily eyelid wipes for 2 weeks
Primary Outcome Measure Information:
Title
OSDI
Description
0-100 score based on the ocular surface disease index (OSDI) questionnaire
Time Frame
Change from baseline OSDI at 2 weeks
Title
meibum quality
Description
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.
Time Frame
Change from baseline meibum quality score at 2 weeks
Title
Corneal fluorescein staining
Description
scored by Oxford staining score
Time Frame
Change from baseline corneal fluorescein staining at 2 weeks
Title
FBUT
Description
fluorescent tear break up time fluorescein tear film break-up time
Time Frame
Change from baseline FTBUT at 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 or older.
Anterior or mixed (anterior + posterior) blepharitis.
Similar clinical condition of both eyes.
A negative urine pregnancy test result for women of childbearing potential
Normal lid position and closure
Ability to understand and provide informed consent to participate in this study
Willingness to follow study instructions and likely to complete all required visits.
Exclusion Criteria:
Any ocular surface disease other than blepharitis.
Known allergy to hypochlorous acid or boric acid.
Eye surgery in the last 6 months.
History of Stevens-Johnson syndrome or ocular pemphigoid
Ocular trauma in the last 6 months.
Use of contact lenses in the last 6 months.
Pregnancy or lactation.
Daily use of makeup on lashes.
Any ocular or systemic medication that might affect the ocular microbiota (antibiotics, immunosuppressants, steroids).
Pregnant or lactating women
Signs of current infection, including fever and current treatment with antibiotics
Liver, renal, or hematologic disease
The use of any other investigational drug
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiaxu Hong
Phone
13917440201
Email
jiaxu_hong@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiaxu Hong
Organizational Affiliation
Eye & ENT Hospital of Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eye & ENT Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiaxu Hong, phD
Phone
13917440201
Email
jiaxu_hong@163.com
First Name & Middle Initial & Last Name & Degree
Hong Zhang, MsC
First Name & Middle Initial & Last Name & Degree
Yuqing Wu, MsC
12. IPD Sharing Statement
Learn more about this trial
0.01% Hypochlorous Acid in the Treatment of Blepharitis
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