NCT02493244已完成不适用
Lipid Layer Thickness Pre and Post Lid Scrubs With Cliradex
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Lipid layer thickness
研究概览
简要总结
Tears play a vital role in vision. A thin layer of tears is always present to cover the surface of the eye for optimal comfort and vision. There are several layers to the tear film, and the outer most layer is comprised of lipids. This lipid layer prevents evaporation of the tears and may be disrupted in people suffering from symptoms of dry eye. Cleaning eyelids with Cliradex wipes have shown to be effective in reducing dry eye symptoms in some patients, and the purpose of this study is to evaluate the tear film lipid layer thickness before and after one months treatment with Cliradex Wipes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is at least 17 years of age and has full legal capacity to volunteer;
- •Has read and signed an information consent letter;
- •Is willing and able to follow instructions and maintain the appointment schedule;
- •Have not worn contact lenses in the past month;
- •Has symptomatic dry eye with SPEED questionnaire score ≥6;
- •Corneal staining grade ≥2 on the Oxford scale.
排除标准
- •Has any known active ocular disease and/or infection;
- •Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- •Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
- •Have used rewetting drops for a period of 2 days prior to screening visit;
- •Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
- •Is pregnant, lactating or planning a pregnancy at the time of enrolment by verbal confirmation at the screening visit;
- •Is aphakic;
- •Has undergone refractive error surgery;
- •Has taken part in another (pharmaceutical) research study within the last 30 days.
结局指标
主要结局
Lipid layer thickness
时间窗: 1 month after baseline visit.
Lipid layer thickness measured in nm.
次要结局
- Non-invasive tear breakup time (NITBUT)(1 month after baseline visit.)
- Dry Eye Questionnaire (SPEED score)(1 month after baseline visit.)
- Overall corneal staining grade(1 month after baseline visit.)
- Conjunctival hyperemia(1 month after baseline visit.)
研究者
研究点 (2)
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