Traditional Chinese Medicine Ultrasonic Atomization Treatment for Dry Eye Disease
Status:
Not yet recruiting
Trial end date:
2025-11-30
Target enrollment:
Participant gender:
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.