Ultrasonic atomization treatment for dry eye disease using traditional Chinese medicine

Traditional Chinese Medicine Ultrasonic Atomization Treatment for Dry Eye Disease: A Randomized, Double-masked, Placebo-controlled Trial

This study is testing if a new ultrasonic treatment using traditional Chinese medicine can help people with dry eye disease feel better when combined with other eye care options.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Chinese University of Hong Kong (Academic / other)
• Locations: 4 sites (Kowloon and 3 other locations)
• Trial ID: NCT06089317 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of traditional Chinese medicine (TCM) ultrasonic atomization as an adjuvant treatment for dry eye disease (DED). It involves a randomized double-masked, active- and placebo-controlled design with 200 participants assigned to various treatment groups, including herbal compounds and artificial tears. Participants will receive TCM ultrasonic atomization treatment six times a week, alongside a wash-out period with lubricant eye drops and a follow-up period of four months. The study aims to provide a novel approach to managing DED, which is often inadequately addressed by standard treatments.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 18-80 with diagnosed dry eye disease symptoms lasting at least six months.

Not a fit: Patients with other ocular surface diseases or those who have undergone recent eye surgeries may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a more effective and holistic approach to managing dry eye disease.

How similar studies have performed: While traditional Chinese medicine approaches have been explored, this specific method of ultrasonic atomization for dry eye disease is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion criteria:

1. 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
2. Ocular Surface Disease Index (OSDI)≥13 and \<33; and
3. The age range between years 18-80, no sex limitation; and
4. Symptoms of dry eye for at least 6 months; and
5. Can complete the questionnaires independently and understand Chinese or English.

Exclusion criteria:

1. 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;
2. Received any refractive surgery and corneal surgery before, including corneal transplant; or any eye surgery in the past 6 months;
3. Receiving DED-related medications, including topical steroid eyedrops, topical antibiotics, topical cyclosporin A, and topical diquafosol;
4. Received intense pulsed laser (IPL) or vectored thermal pulsation (VTP) therapy in the past 12 months;
5. Received topical antiglaucomatous treatment in the past 12 months
6. Plans to use contact lenses during treatment and follow-up periods or used contact lenses 2 weeks before the baseline measurement and recruitment;
7. Had or currently suffering from severe cardiopulmonary disease, liver and kidney dysfunction, and severe blood system diseases;
8. Suffering from glucose-6-phosphate dehydrogenase deficiency (G6PD);
9. Had or currently suffering from specific respiratory diseases, e.g. emphysema, bronchitis, asthma, chronic obstructive pulmonary disease, bronchial dilatation;
10. Has adverse reaction history to herbs used in this study before;
11. Whose TCM constitution is manifested as "yang-deficiency" or diagnosed by TCM practitioners that their TCM syndrome is not suitable for the atomization treatment;
12. Pregnancy, preparation for pregnancy, or lactation;

Where this trial is running

Kowloon and 3 other locations

• The Chinese University of Hong Kong Eye Centre (CUHKEC) — Kowloon, Hong Kong (Recruiting)
• Hong Kong Eye Hospital — Kowloon, Hong Kong (Recruiting)
• The CUHK Medical Centre (CUHKMC) — Shatin, Hong Kong (Recruiting)
• Prince of Wales Hospital — Shatin, Hong Kong (Recruiting)

Study contacts

• Principal investigator: Kelvin KL Chong, MBChB — Chinese University of Hong Kong
• Study coordinator: Jennifer Tsoi

Conditions Dry Eye Syndromes; Traditional Chinese Medicine; Ultrasonic Atomization; Randomized Controlled Trial