Traditional Chinese Medicine Ultrasonic Atomization Treatment for Dry Eye Disease

The Chinese University of Hong Kong

Status: Enrolling

Conditions: Dry Eye Syndromes

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06089317

CMDF-21B2005A_R1

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

200 participants in 5 patient groups, including a placebo group

Compound Decoction (CD) group

Active Comparator group

Treatment:

Drug: Artificial Tears (AT)

Drug: TCM ultrasonic atomization treatment with herbal Compound Decoction (CD)

Dendrobii Caulis (DC) group

Active Comparator group

Treatment:

Drug: Artificial Tears (AT)

Drug: TCM ultrasonic atomization treatment with Dendrobii Caulis (DC)

Houttuynia Cordata (HC) group

Active Comparator group

Treatment:

Drug: Artificial Tears (AT)

Drug: TCM ultrasonic atomization treatment with Houttuynia Cordata (HC)

Placebo Atomization (PA) group

Placebo Comparator group

Treatment:

Drug: Artificial Tears (AT)

Drug: Placebo TCM ultrasonic atomization treatment (PA)

Artificial Tears (AT) group

Other group

Treatment:

Drug: Artificial Tears (AT)