Evaluation of the Lubricity of Daily Disposable Silicone Hydrogel Contact Lenses After Wear
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Average Coefficient of Friction of Worn Lenses at 16 Hours
研究概览
简要总结
The purpose of this study is to measure the coefficient of friction of three silicone hydrogel, daily disposable contact lenses after 16 hours of wear.
详细描述
In this 3-treatment, 3-period, 6-sequence crossover study, each participant will wear all 3 products in randomized order, 1 product at a time, with a washout period of up to 7 days between treatment periods. Lenses will be collected for ex-vivo lubricity analysis. The ex-vivo lubricity analysis will be conducted under a separate non-clinical protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must sign an informed consent form.
- •Soft contact lens wearer (both eyes).
- •Willing to wear study lenses at least 16 waking hours and attend all study visits.
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear.
- •Use of systemic or ocular medications for which contact lens wear could be contraindicated.
- •Use of artificial tears and rewetting drops during the study.
- •Monocular (only 1 eye with functional vision) or fit with only 1 lens.
- •History of herpetic keratitis, ocular surgery, or irregular cornea.
- •Pregnant.
- •Other protocol-specified exclusion criteria may apply.
结局指标
主要结局
Average Coefficient of Friction of Worn Lenses at 16 Hours
时间窗: Day 1, Hour 16, each product
Worn contact lenses were removed from the participant's eye and the coefficient of friction was measured by the inclined plane method. A lower coefficient of friction may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only.
次要结局
- Average Coefficient of Friction of Unworn Lenses(Day 1 (each product))