0.01% Hypochlorous Acid in the Treatment of Blepharitis

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

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

Conditions
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Blepharitis

Intervention / Treatment
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* Drug: 0.01% hypochlorous acid
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective, controlled, randomized study.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment arm<br>0.01%hypochlorous acid group | Drug: 0.01% hypochlorous acid<br>* once daily 0.01% hypochlorous acid topical treatment via ultrasonic atomization for 2 weeks<br>* Other names: 0.01%HOCI;|
| Placebo Comparator: Placebo<br>eyelid wipes | Drug: Placebo<br>* once daily eyelid wipes for 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blepharitis, Hypochlorous Acid, Eyelid cleanser, Eyelid hygiene, Meibomian gland dysfunction