0.01% Hypochlorous Acid in the Treatment of Blepharitis

Blepharitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05608980
• Other study ID #: 0.01% Hypochlorous Acid
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: May 1, 2023

Study information

• Verified date: November 2022
• Source: Eye & ENT Hospital of Fudan University
• Contact: Jiaxu Hong
• Phone: 13917440201
• Email: jiaxu_hong[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blepharitis

Intervention

Drug:
• 0.01% hypochlorous acid
once daily 0.01% hypochlorous acid topical treatment via ultrasonic atomization for 2 weeks
• Placebo
once daily eyelid wipes for 2 weeks

Locations

Country	Name	City	State
China	Eye & ENT Hospital of Fudan University	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Eye & ENT Hospital of Fudan University	ShuGuang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OSDI	0-100 score based on the ocular surface disease index (OSDI) questionnaire	Change from baseline OSDI at 2 weeks
Primary	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
Primary	Corneal fluorescein staining	scored by Oxford staining score	Change from baseline corneal fluorescein staining at 2 weeks
Primary	FBUT	fluorescent tear break up time fluorescein tear film break-up time	Change from baseline FTBUT at 2 weeks