NCT00902850已完成不适用
One-Day Dispensing Clinical Evaluation of SofLens Daily Disposable Lenses Compared to 1-Day Acuvue TruEye Lenses
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Clinical Performance
研究概览
简要总结
The objective of this one-day study will be to evaluate the clinical performance of SofLens Daily Disposable lenses compared to that of a marketed 1 Day Contact Lens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
- •Have no active ocular disease or allergic conjunctivitis.
- •Not be using any topical ocular medications.
排除标准
- •Participating in a conflicting study.
- •Considered by the Investigator to not be a suitable candidate for participation.
结局指标
主要结局
Clinical Performance
时间窗: Insertion, 4 hours & End of Day
Comfort of lens wear compared at insertion of lens, 4 hours after insertion, and end of day (8-16 hours of wear-time). Score was a number on a scale 0-100, graded by the participants, and included lens edge awareness, scratchiness/grittiness, foreign body sensation, and general lens awareness.
次要结局
未报告次要终点
研究者
研究点 (2)
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