NCT01611922已完成不适用
Optimization of Assessment and Grading for Lid Wiper Epitheliopathy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- LWE-associated staining score
研究概览
简要总结
The purpose of this study is to assess eyelid margin staining, termed "lid wiper epitheliopathy" (LWE), in three populations. The hypothesis is LWE will be more prevalent in symptomatic contact lens wearers than non-symptomatic contact lens wearers and least prevalent in asymptomatic non-contact lens wearers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •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;
- •Has had an ocular examination in the last two years;
- •Has clear corneas and no active ocular disease;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Has any ocular disease;
- •Has a systemic condition that may affect a study outcome variable;
- •Is using any systemic or topical medications that may affect ocular health;
- •Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
- •Has undergone corneal refractive surgery;
- •Currently wears contact lenses on an extended wear basis (overnight);
- •Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities;
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
LWE-associated staining score
时间窗: 3 minutes after dye instillation
Lens wearers must wear lenses for a minimum of 8 hours on the day of assessment, after which lenses will be removed and dye will be instilled. LWE-associated staining will be assessed by the investigator and reported as a composite score based on Korb's method.
次要结局
未报告次要终点
研究者
研究点 (1)
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