Status:
RECRUITING
Traditional Chinese Medicine Ultrasonic Atomization Treatment for Dry Eye Disease
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Dry Eye Syndromes
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Dry eye disease (DED) is the most prevalent ocular surface disease worldwide. Standard treatments like artificial tears show limited effect. Regarding the ultrasonic atomization, the ultrasonic nebuli...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- At least one eye of subjects meets DED diagnostic criteria as the Tear Film and Ocular Surface Society (TFOS) Dry Eye Workshop (DEWS II); and
- Ocular Surface Disease Index (OSDI)≥13 and \<33; and
- The age range between years 18-80, no sex limitation; and
- Symptoms of dry eye for at least 6 months; and
- Can complete the questionnaires independently and understand Chinese or English.
- Exclusion criteria:
- Had or currently suffering from other concomitant ocular surface diseases, including chronic conjunctivitis, ocular rosacea, cicatricial pemphigoid, graft-versus-host disease, limbal stem cell deficiency, and severe ocular allergy;
- Received any refractive surgery and corneal surgery before, including corneal transplant; or any eye surgery in the past 6 months;
- Receiving DED-related medications, including topical steroid eyedrops, topical antibiotics, topical cyclosporin A, and topical diquafosol;
- Received intense pulsed laser (IPL) or vectored thermal pulsation (VTP) therapy in the past 12 months;
- Received topical antiglaucomatous treatment in the past 12 months
- Plans to use contact lenses during treatment and follow-up periods or used contact lenses 2 weeks before the baseline measurement and recruitment;
- Had or currently suffering from severe cardiopulmonary disease, liver and kidney dysfunction, and severe blood system diseases;
- Suffering from glucose-6-phosphate dehydrogenase deficiency (G6PD);
- Had or currently suffering from specific respiratory diseases, e.g. emphysema, bronchitis, asthma, chronic obstructive pulmonary disease, bronchial dilatation;
- Has adverse reaction history to herbs used in this study before;
- Whose TCM constitution is manifested as "yang-deficiency" or diagnosed by TCM practitioners that their TCM syndrome is not suitable for the atomization treatment;
- Pregnancy, preparation for pregnancy, or lactation;
Exclusion
Key Trial Info
Start Date :
July 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06089317
Start Date
July 28 2024
End Date
November 30 2025
Last Update
August 21 2024
Active Locations (4)
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1
The Chinese University of Hong Kong Eye Centre (CUHKEC)
Kowloon, Hong Kong, 000000
2
Hong Kong Eye Hospital
Kowloon, Hong Kong
3
The CUHK Medical Centre (CUHKMC)
Shatin, Hong Kong, 000 000
4
Prince of Wales Hospital
Shatin, Hong Kong, 000000