NCT03888482已完成不适用
Clinical Comparison of DDT2 Contact Lens and a Daily Disposable Contact Lens - Study 2
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 9
- 主要终点
- Least Squares Mean Distance Visual Acuity With Study Lenses
研究概览
简要总结
The purpose of this study was to evaluate visual acuity at distance when wearing DDT2 contact lenses compared to Clariti contact lenses.
详细描述
Subjects were expected to attend 3 study visits and wear the DDT2 and Clariti study lenses in a crossover design for approximately 14 - 20 days (7 - 10 days for each product).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Able to understand and sign an Informed Consent Form that has been approved by an Institutional Review Board.
- •Willing and able to attend all scheduled study visits as required per protocol.
- •Current wearer of spherical soft contact lenses.
排除标准
- •Any ocular condition that contraindicates contact lens wear.
- •Previous or current habitual wearer of clariti® or DAILIES TOTAL1® contact lenses.
结局指标
主要结局
Least Squares Mean Distance Visual Acuity With Study Lenses
时间窗: Day 8, each product
Visual acuity was assessed and collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.
次要结局
未报告次要终点
研究者
研究点 (9)
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