Traditional Chinese Medicine Ultrasonic Atomization Treatment for Dry Eye Disease

Plain-language summary

This study compared traditional Chinese medicine ultrasonic atomization treatment using various herbal preparations against artificial tears and placebo in people with dry eye disease. People aged 18-80 with dry eye symptoms for at least 6 months took part. It has no assigned phase and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Completed

Sponsor

Chinese University of Hong Kong

Intervention

TCM ultrasonic atomization treatment with herbal Compound Decoction (CD), TCM ultrasonic atomization treatment with Dendrobii Caulis (DC), TCM ultrasonic atomization treatment with Houttuynia Cordata (HC), Placebo TCM ultrasonic atomization treatment (PA), Artificial Tears (AT)

Start date

7/28/2024

Estimated completion

6/22/2025

Countries

Hong Kong

Related genes

Locations

• Kowloon, Hong Kong
• Kowloon, Hong Kong
• Shatin, Hong Kong
• Shatin, Hong Kong

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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;