NCT04421300已完成不适用
Clinical Efficacy of Smile Exercise Versus 0.1% Hyaluronic Acid Sodium Eye Drops for Dry Eye Symptoms in Patients With Dry Eye Disease: a Randomized, Controlled, Non-inferiority Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 299
- 试验地点
- 1
- 主要终点
- Change of Ocular Surface Disease Index (OSDI) Score
研究概览
简要总结
The objective of the study is to evaluate the effectiveness of laughter therapy in relieving the symptoms of dry eye disease.
详细描述
The study is designed to: Test the hypothesis that smile exercise is an effective treatment for Dry Eye Disease (DED) . Better understand the status of emotion, quality of sleep and life in DED patient by describing and evaluating a comprehensive set of features and treatment over 2 months of observation in a well-characterized group of patients.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sign the informed consent approved by the Ethics Committee,
- •18 to 45 years of age,
- •Meetting the dry eye diagnostic criteria of DEWs Ⅱ and demonstrating the following 2 condition in the same eye at screening and baseline visits (Same signs must present at both in Screening visit and Baseline visit). The same signs must be present in the same eye on both visits. The following parameters:.
- •Ocular Surface Disease Index (OSDI) score: 18-80 at and baseline visit.
- •Tear film break up time (TFBUT)<8s.
- •Best corrected visual acuity ≥10/20 in each eye
- •Intraocular pressure (IOP) ≥5mmHg and≤21mmHg in each eye
- •Women of child-bearing potential must agree to use a reliable method of contraception during study participation and must demonstrate a negative urine pregnancy test at the Screening Visit.
- •Feasible for all visits and willing to follow instructions from the study investigator.
排除标准
- •Corneal fluorescein staining present >5 score.
- •Contact lens wearing history:
- •Used contact lenses within last 14 days prior to the Screening Visit.
- •Unwilling to avoid using contact lenses druing the study.
- •Any corneal surgery within 12 months before Screening Visit .
- •Participation in other medical studies 3 months before screening Visit.
- •Current or previous diagnosis of any following ocular conditions in 3 months:
- •i). acute allergic conjunctivitis ii). infection (e.g. bacterial, viral, protozoan or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids) iii). inflammation (e.g., retinitis, macular inflammation, choroiditis, uveitis, scleritis, episcleritis, keratitis)
- •Eyelid abnormalities that affect lid function (e.g. lagophthalmos, blepharospasm, ectropion, entropion, severe trichiasis, etc.)
- •Extensive ocular surface scarring or condition that may compromise ocular surface integrity such as Stevens-Johnson syndrome, prior chemical burn, recurrent corneal erosions, persistent corneal epithelial defects, prior ocular trauma, etc.)
- •Currently diagnosis of glaucoma and under glaucoma medication or surgery treatment
- •Currently using, or intent to have any specific treatments for dry eye disease
- •Fluorescein sodium allergy
- •Pregnant, nursing, or lactating
- •Neurological or psychiatric disorders (moderate anxiety, depression and sleep disorders)
- •Uncontrolled ocular or systemic diseases
- •History of epilepsy .
- •The researchers did not consider the patient is appropriate for inclusion in this study
- •Cognitive or psychiatric defect that precludes informed consent or ability to perform requirements in the investigation.
研究组 & 干预措施
smile exercise
Experimental
smile exercise, 4 times a day，8 weeks
干预措施: smile exercise (Behavioral)
0.1% Sodium Hyaluronate Eye Drops
Active Comparator
0.1% sodium hyaluronate, 4 times a day, 8 weeks.
干预措施: 0.1% sodium hyaluronate eye drop (Drug)
结局指标
主要结局
Change of Ocular Surface Disease Index (OSDI) Score
时间窗: 12 weeks
OSDI scores from 1, 2, 4, 6, 8, 10 and 12 weeks minus values from baseline. OSDI scores range from 0 to 100, score 0 indicating no ocular discomfort and higher scores indicating greater symptom severity. The minimal clinically significant change is 10 points.
次要结局
- Proportion of Participants with 10 Points or More Decreased in OSDI(12 weeks)
- Change in Corneal Fluorescein Staining Score(12 weeks)
- Change in Non-invasive Tear film breakup time (NI-BUT)(12 weeks)
- Change in Self-Rating Anxiety Scale (SAS)(12 weeks)
- Change in Self-Rating Depression Scale (SDS)(12 weeks)
- Change in Tear Meniscus Height (TMH) by Keratography(12 weeks)
- Change from Baseline in Lipid layer thickness (LLT)(12 weeks)
- Change in Subjective Happiness Scale(12 weeks)
- Change in Pittsburgh Sleep Quality Index (PSQI)(12 weeks)
- Change in SF-36 Physical Health Subscale(12 weeks)
- Change in SF-36 Mental Health Subscale(12 weeks)
研究者
研究点 (1)
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