0.01% Hypochlorous Acid in the Treatment of Blepharitis

NCT ID: NCT05608980

Last Updated: 2022-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2023-05-01

Brief Summary

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

Detailed Description

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Conditions

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Blepharitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A prospective, controlled, randomized study.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Treatment arm

0.01%hypochlorous acid group

Group Type ACTIVE_COMPARATOR

0.01% hypochlorous acid

Intervention Type DRUG

once daily 0.01% hypochlorous acid topical treatment via ultrasonic atomization for 2 weeks

Placebo

eyelid wipes

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

once daily eyelid wipes for 2 weeks

Interventions

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0.01% hypochlorous acid

once daily 0.01% hypochlorous acid topical treatment via ultrasonic atomization for 2 weeks

Intervention Type DRUG

Placebo

once daily eyelid wipes for 2 weeks

Intervention Type DRUG

Other Intervention Names

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0.01%HOCI

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ShuGuang Hospital

OTHER

Sponsor Role collaborator

Eye & ENT Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jiaxu Hong

Role: PRINCIPAL_INVESTIGATOR

Eye & ENT Hospital of Fudan University

Locations

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Eye & ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jiaxu Hong

Role: CONTACT

13917440201

Facility Contacts

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Jiaxu Hong, phD

Role: primary

13917440201

Other Identifiers

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0.01% Hypochlorous Acid

Identifier Type: -

Identifier Source: org_study_id

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