NCT04464044已完成不适用
Clinical Performance of a Daily Disposable Toric Silicone Hydrogel Contact Lens
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Percent of lenses with axis orientation within ±30° from the intended axis, 10 minutes after lens insertion
研究概览
简要总结
The purpose of this study is to obtain on-eye clinical performance data to evaluate the stability of axis orientation of DDT2 toric contact lenses in the intended population.
详细描述
This is a single-visit, non-dispense study where subjects will be exposed to the test lenses for approximately 1 hour.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
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
- •Able to understand and sign an informed consent form;
- •Successful wear of spherical or toric soft contact lenses in both eyes, as specified in the protocol;
- •Willing to NOT use rewetting/lubricating drops at any time during the study;
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Any eye condition that would contraindicate contact lens wear, as determined by the Investigator;
- •History of eye surgery within the previous 12 months, as specified in the protocol;
- •Current or history of dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear;
- •Other protocol-specified exclusion criteria may apply.
结局指标
主要结局
Percent of lenses with axis orientation within ±30° from the intended axis, 10 minutes after lens insertion
时间窗: Day 1, 10 minutes after lens insertion
Axis orientation (orientation of the scribe mark) will be assessed by slit lamp examination and recorded as deviations from intended axis.
次要结局
未报告次要终点
研究者
研究点 (2)
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