0.01% Hypochlorous Acid in the Treatment of Blepharitis

Eye & ENT Hospital of Fudan University

Status: Enrolling

Conditions: Blepharitis

Treatments: Drug: Placebo; Drug: 0.01% hypochlorous acid

Study type: Interventional

Funder types: Other

Identifiers

NCT05608980

0.01% Hypochlorous Acid

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Treatment arm

Active Comparator group

Description:

0.01%hypochlorous acid group

Treatment:

Drug: 0.01% hypochlorous acid

Placebo

Placebo Comparator group

Description:

eyelid wipes

Treatment:

Drug: Placebo