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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05608980
Other study ID # 0.01% Hypochlorous Acid
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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