Blepharitis
Conditions
Keywords
Blepharitis, Hypochlorous Acid, Eyelid cleanser, Eyelid hygiene, Meibomian gland dysfunction
Brief summary
This is a multi-center, multidisciplinary, open-label, randomized controlled prospective clinical study.
Interventions
once daily 0.01% hypochlorous acid topical treatment via ultrasonic atomization for 2 weeks
DRUGPlacebo
once daily eyelid wipes for 2 weeks
Sponsors
ShuGuang Hospital
Eye & ENT Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
A prospective, controlled, randomized study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactJiaxu Hong
Outcome results
None listed