NCT04254003已完成不适用
Clinical Performance Evaluation of Two Daily Disposable Silicone Hydrogel Toric Contact Lenses
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 4
- 主要终点
- Percent of DT1 toric lenses with axis orientation within ±30° from the intended axis, 10 min after lens insertion
研究概览
简要总结
The purpose of this study is to evaluate the rotational behavior of DT1 Toric contact lenses.
详细描述
This is a single visit, non-dispense study where subjects will be exposed to the test and control lenses for approximately 1 hour each.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Device Feasibility
- 盲法
- Single (Participant)
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
- •Current wearer of any commercial soft daily wear contact lens with at least 3 months of wearing experience with a minimum wearing time of 5 days per week and 8 hours per day.
- •Requiring contact lens (manifest refraction) of a cylindrical power of -0.75 to -2.50 diopter cylinder (DC).
- •Best corrected distance visual acuity 20/25 or better Snellen in each eye (as determined by manifest refraction at screening).
- •Willing to NOT use rewetting/lubricating drops at any time during the study. Other protocol-defined inclusion criteria may apply.
排除标准
- •Any anterior segment infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator.
- •Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator.
- •History of refractive surgery or plan to have refractive surgery during the study or irregular cornea in either eye.
- •Eye injury in either eye within 12 weeks immediately prior to enrollment for this trial.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Percent of DT1 toric lenses with axis orientation within ±30° from the intended axis, 10 min after lens insertion
时间窗: Day 1, 10 minutes after lens insertion, each product
A slit lamp will be used to observe axis orientation.
次要结局
未报告次要终点
研究者
研究点 (4)
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