Traditional Chinese Medicine Ultrasonic Atomization Treatment for Dry Eye Disease: A Randomized, Double-masked, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Change in the Ocular Surface Disease Index (OSDI)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Ocular Surface Disease Index (OSDI)≥13 and <33; and
- •The age range between years 18-80, no sex limitation; and
- •Symptoms of dry eye for at least 6 months; and
- •Can complete the questionnaires independently and understand Chinese or English.
排除标准
- •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;
- •Received any refractive surgery and corneal surgery before, including corneal transplant; or any eye surgery in the past 6 months;
- •Receiving DED-related medications, including topical steroid eyedrops, topical antibiotics, topical cyclosporin A, and topical diquafosol;
- •Received intense pulsed laser (IPL) or vectored thermal pulsation (VTP) therapy in the past 12 months;
- •Received topical antiglaucomatous treatment in the past 12 months
- •Plans to use contact lenses during treatment and follow-up periods or used contact lenses 2 weeks before the baseline measurement and recruitment;
- •Had or currently suffering from severe cardiopulmonary disease, liver and kidney dysfunction, and severe blood system diseases;
- •Suffering from glucose-6-phosphate dehydrogenase deficiency (G6PD);
- •Had or currently suffering from specific respiratory diseases, e.g. emphysema, bronchitis, asthma, chronic obstructive pulmonary disease, bronchial dilatation;
- •Has adverse reaction history to herbs used in this study before;
- •Whose TCM constitution is manifested as "yang-deficiency" or diagnosed by TCM practitioners that their TCM syndrome is not suitable for the atomization treatment;
- •Pregnancy, preparation for pregnancy, or lactation;
研究组 & 干预措施
Compound Decoction (CD) group
干预措施: TCM ultrasonic atomization treatment with herbal Compound Decoction (CD) (Drug)
Compound Decoction (CD) group
干预措施: Artificial Tears (AT) (Drug)
Dendrobii Caulis (DC) group
干预措施: TCM ultrasonic atomization treatment with Dendrobii Caulis (DC) (Drug)
Dendrobii Caulis (DC) group
干预措施: Artificial Tears (AT) (Drug)
Houttuynia Cordata (HC) group
干预措施: TCM ultrasonic atomization treatment with Houttuynia Cordata (HC) (Drug)
Houttuynia Cordata (HC) group
干预措施: Artificial Tears (AT) (Drug)
Placebo Atomization (PA) group
干预措施: Placebo TCM ultrasonic atomization treatment (PA) (Drug)
Placebo Atomization (PA) group
干预措施: Artificial Tears (AT) (Drug)
Artificial Tears (AT) group
干预措施: Artificial Tears (AT) (Drug)
结局指标
主要结局
Change in the Ocular Surface Disease Index (OSDI)
时间窗: baseline to 4th week
The Ocular Surface Disease Index (OSDI) is a 12-item symptom frequency-based questionnaire. It is self-administered to assess DED-related symptoms and severity. The final OSDI score is calculated by dividing the product of the total sum of the score and 25 by the total number of answered questions, with a range from 0 to 100. The score reflects the severity of DED(normal: 0-12, mild: 13-22, moderate: 23-32, severe: \>33).
Change in Non-invasive Tear Break-up Times (NIBUT)
时间窗: baseline to 4th week
The non-invasive tear break-up time (NIBUT) will be measured by the OCULUS Keratograph® 5M (Oculus, Wetzlar, Germany). Subjects will be instructed to keep their eyes on as much as possible during the examination. First and average NIBUT will be recorded by the machine accordingly. Shortening NIBUT(\< 10 seconds) suggests instability of the tear film.
次要结局
- Change in Ocular Surface Disease Index (OSDI)(4 months)
- Change in symptom Assessment iN Dry Eye (SANDE, modified)(4 months)
- Change in 36-Item Short Form Health Survey (SF-36)(4 months)
- Change in the Work Productivity and Activity Impairment Questionnaire: General Health V2.0 (WPAI:GH)(4 months)
- Change in Quality of Expressed Meibum(4 months)
- Change in Lid Margin and Eyelash Abnormalities(4 months)
- Changes in Matrix metallopeptidase 9 (MMP-9)(4 months)
- Changes in Schirmer I test(4 months)
- Change in Non-Invasive Tear Break Up Times (NIBUT)(4 months)
- Changes in Tear Meniscus Height (TMH)(4 months)
- Changes in Bulbar Redness(4 months)
- Changes in Lipid Layer Thickness(4 months)
- Changes in Partial Blinking Rate(4 months)
- Changes in Meiboscore(4 months)
- Change in Tear Film Breakup Time (TBUT)(4 months)
- Change in Corneal and Conjunctival Fluorescein Staining(4 months)
- Change in Expressibility of Meibomian Glands in the Meibomian Glands Yielding Liquid Secretion (MGYLS) (the inferior eyelid)(4 months)
- Change in Tear Film Osmolarity (TFO)(4 months)
- Adverse events (AEs)(4 months)
研究者
Kelvin Kam Lung Chong, MD
Associate Professor, Department of Ophthalmology and Visual Sciences, CUHK
Chinese University of Hong Kong