Traditional Chinese Medicine Ultrasonic Atomization Treatment for Dry Eye Disease

Last updated: August 19, 2024
Sponsor: Chinese University of Hong Kong
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sjogren's Syndrome

Dry Eyes

Eyelid Inflammation

Treatment

Placebo TCM ultrasonic atomization treatment (PA)

TCM ultrasonic atomization treatment with Dendrobii Caulis (DC)

Placebo TCM ultrasonic atomization treatment (PA)

Clinical Study ID

NCT06089317
CMDF-21B2005A_R1
  • Ages 18-80
  • All Genders

Study 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 nebulizer produces consistent steam from the solution with a treatment effect delivered to the ocular surface. We aim to evaluate the effectiveness and safety of traditional Chinese medicine (TCM) ultrasonic atomization as an adjuvant treatment for DED.

This is a randomized double-masked, active- and placebo-controlled trial. 200 subjects will be equally assigned to the herbal compound decoction(CD) group, dendrobium caulis (DC) group, houttuynia cordata (HC) group, placebo atomization(PA) group, and artificial tear (AT) group by stratified permuted block randomization.

Subjects of CD, DC, HC, and PA groups will receive TCM ultrasonic atomization treatment (6 times/week). All patients will receive hypromellose 0.3% w/v lubricant eye drops for a 1-week wash-out and a 4-month follow-up period. Outcomes included non-invasive tear break-up times, corneal and conjunctival fluorescein staining, and other dry eye-related parameter examined by LipiView II Ocular Surface Interferometer, OCULUS® Keratograph 5M, and slit lamp biomicroscope evaluated by masked clinical assessors at baseline, week 1, 2, 3, 4 and month 2, 3, 4. The other subjective questionnaires like the Ocular Surface Disease Index (OSDI) questionnaire are also selected.

Eligibility Criteria

Inclusion

Inclusion criteria:

  1. At least one eye of subjects meets DED diagnostic criteria as the Tear Film andOcular 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

Exclusion criteria:

  1. Had or currently suffering from other concomitant ocular surface diseases, includingchronic conjunctivitis, ocular rosacea, cicatricial pemphigoid, graft-versus-hostdisease, limbal stem cell deficiency, and severe ocular allergy;

  2. Received any refractive surgery and corneal surgery before, including cornealtransplant; or any eye surgery in the past 6 months;

  3. Receiving DED-related medications, including topical steroid eyedrops, topicalantibiotics, topical cyclosporin A, and topical diquafosol;

  4. Received intense pulsed laser (IPL) or vectored thermal pulsation (VTP) therapy inthe 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 contactlenses 2 weeks before the baseline measurement and recruitment;

  7. Had or currently suffering from severe cardiopulmonary disease, liver and kidneydysfunction, 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 TCMpractitioners that their TCM syndrome is not suitable for the atomization treatment;

  12. Pregnancy, preparation for pregnancy, or lactation;

Study Design

Total Participants: 200
Treatment Group(s): 9
Primary Treatment: Placebo TCM ultrasonic atomization treatment (PA)
Phase:
Study Start date:
July 28, 2024
Estimated Completion Date:
November 30, 2025

Connect with a study center

  • Hong Kong Eye Hospital

    Kowloon,
    Hong Kong

    Active - Recruiting

  • The Chinese University of Hong Kong Eye Centre (CUHKEC)

    Kowloon, 000000
    Hong Kong

    Active - Recruiting

  • Prince of Wales Hospital

    Shatin, 000000
    Hong Kong

    Active - Recruiting

  • The CUHK Medical Centre (CUHKMC)

    Shatin, 000 000
    Hong Kong

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.