0.01% Hypochlorous Acid in the Treatment of Blepharitis

Sponsor

Eye & ENT Hospital of Fudan University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05608980

Collaborator

ShuGuang Hospital (Other)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Blepharitis	Drug: 0.01% hypochlorous acid Drug: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A prospective, controlled, randomized study.A prospective, controlled, randomized study.

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

OSDI [Change from baseline OSDI at 2 weeks]
0-100 score based on the ocular surface disease index (OSDI) questionnaire
meibum quality [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.
Corneal fluorescein staining [Change from baseline corneal fluorescein staining at 2 weeks]
scored by Oxford staining score
FBUT [Change from baseline FTBUT at 2 weeks]
fluorescent tear break up time fluorescein tear film break-up time

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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