Traditional Chinese Medicine Ultrasonic Atomization Treatment for Dry Eye Disease

Launched by CHINESE UNIVERSITY OF HONG KONG · Oct 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for dry eye disease (DED) using traditional Chinese medicine (TCM) delivered through ultrasonic atomization. This method creates a fine mist from herbal solutions to provide relief directly to the eyes. The researchers want to see if this treatment is effective and safe when compared to other options, including artificial tears and a placebo treatment.

To participate in the trial, individuals aged 18 to 80 who have been experiencing dry eye symptoms for at least six months may be eligible, as long as they meet specific eye health criteria. Participants will receive treatment six times a week for four months and will also complete questionnaires to track their symptoms. This trial aims to find better ways to help those suffering from dry eyes, especially since standard treatments like artificial tears don’t always work well.

Gender

ALL

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;