Evaluation of the Lubricity of DAILIES TOTAL1® Contact Lenses After Wear
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 主要终点
- Average Coefficient of Friction (CF) at 16 Hours Compared to Unworn
研究概览
简要总结
The primary objective of the study is to demonstrate that the lubricity of DAILIES TOTAL1® (DT1) lenses after 16 hours of wear is equivalent to the lubricity of unworn DT1 lenses.
详细描述
In this study, participants wore study lenses for 2 specified time periods (16 hours and 15 minutes, treatment sequence randomized) following which lenses were collected for ex vivo lubricity analysis. The ex vivo lubricity analysis was evaluated 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
- •Willing and able to sign Informed Consent document.
- •Adapted, current soft contact lens wearer.
- •Requires contact lens powers within the specified range of -0.50 diopters (D) to -10.00D.
- •Cylinder between 0.00D and -1.00D (inclusive) in both eyes at Visit 1 manifest refraction.
- •Vision correctable to 20/25 or better in each eye at distance with study lenses.
- •Willing to wear study lenses at least 16 waking hours in one day and attend all study visits.
- •Able to be successfully fitted with study lenses.
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Any ocular infection, inflammation, abnormality or active disease that would contraindicate contact lens wear, as determined by the Investigator.
- •Use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator.
- •Use of artificial tears and rewetting drops during the study.
- •Monocular (only one eye with functional vision) or fit with only one lens.
- •Any abnormal ocular condition observed during the Visit 1 slit lamp examination.
- •History of herpetic keratitis, ocular surgery, or irregular cornea.
- •Pregnant.
- •Participation in any clinical study within 30 days of Visit
- •Other protocol-specified exclusion criteria may apply.
结局指标
主要结局
Average Coefficient of Friction (CF) at 16 Hours Compared to Unworn
时间窗: Day 1 (for each period), 16 hours
Worn contact lenses were removed from the participant's eye. The CF was calculated and compared to the CF for unworn contact lenses. A lower CF 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 at 15 Minutes(Day 1 (for each period), 15 minutes)