NCT06089317

Traditional Chinese Medicine Ultrasonic Atomization Treatment for Dry Eye Disease

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dry Eye Syndromes

Interventions

Type	Name	Description
DRUG	TCM ultrasonic atomization treatment with herbal Compound Decoction (CD)	The subjects will receive TCM ultrasonic atomization treatment with the ultrasonic nebulizer (WH-2000, YueHua, China) 6 days a week, once daily, 10 minutes per session, for 4 weeks. The solution for atomization of the CD group is TCM compound decoction. The prescription of atomization solution in the CD group contains Honeysuckle flower (金銀花) 5g, Chrysanthemum flower (菊花) 5g, Pale betterflybush flower (密蒙花) 5g, Mild mint herb (薄荷) 5g, Barbary wolfberry fruit (枸杞子) 10g, and Ophiopogon japonicus (麥冬) 5g. Subjects will be treated with hypromellose 0.3% w/v eye drops four times per day too.
DRUG	TCM ultrasonic atomization treatment with Dendrobii Caulis (DC)	The subjects will receive TCM ultrasonic atomization treatment with the ultrasonic nebulizer (WH-2000, YueHua, China) 6 days a week, once daily, 10 minutes per session, for 4 weeks. The solution for atomization of the DC group is Dendrobii Caulis extracts. The prescription of the DC group contains Dendrobium (石斛) 35g. Subjects will be treated with hypromellose 0.3% w/v eye drops four times per day too.
DRUG	TCM ultrasonic atomization treatment with Houttuynia Cordata (HC)	The subjects will receive TCM ultrasonic atomization treatment with the ultrasonic nebulizer (WH-2000, YueHua, China) 6 days a week, once daily, 10 minutes per session, for 4 weeks. The solution for atomization of the HC group is Heartleaf Houttuynia Herb extracts. The prescription of the HC group contains Heartleaf Houttuynia Herb(魚腥草) 35g. Subjects will be treated with hypromellose 0.3% w/v eye drops four times per day too.
DRUG	Placebo TCM ultrasonic atomization treatment (PA)	The subjects will receive TCM ultrasonic atomization treatment with the ultrasonic nebulizer (WH-2000, YueHua, China) 6 days a week, once daily, 10 minutes per session, for 4 weeks. The solution for atomization of the PA group is low-concentration compound decoction (5%) same with the CD group. Subjects will be treated with hypromellose 0.3% w/v eye drops four times per day too.
DRUG	Artificial Tears (AT)	The subjects will receive lubricant eye drop (Hypromellose 0.3% w/v Eye Drops) four times per day only.

Timeline

• Start date: 2024-07-28
• Primary completion: 2025-06-22
• Completion: 2025-06-22
• First posted: 2023-10-18
• Last updated: 2026-03-19

Locations

4 sites across 1 country: Hong Kong