0.01% Hypochlorous Acid in the Treatment of Blepharitis

Not Applicable

Recruiting

• Conditions: Blepharitis
• Interventions: Drug: Placebo; Drug: 0.01% hypochlorous acid

• Registration Number: NCT05608980
• Lead Sponsor: Eye & ENT Hospital of Fudan University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2022-10-27
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-04
• Last Update Submitted: 2022-11-04
• Study First Posted: 2022-11-08
• Last Update Posted: 2022-11-08
• Primary Completion: 2022-12-01
• Study Completion: 2023-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	eyelid wipes
Treatment arm	0.01% hypochlorous acid	0.01%hypochlorous acid group

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Eye & ENT Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China