The Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 29
- 主要终点
- Least Squares Mean Distance VA With Study Lenses at Week 1
研究概览
简要总结
The purpose of this study is to assess the clinical performance of two reusable silicone hydrogel contact lenses when worn on a daily wear basis.
详细描述
In this crossover study, subjects will wear each lens product for approximately 14 days and attend 7 scheduled visits. The expected overall duration of exposure to the study products is approximately 28 days.
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
- •Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.
- •Best Corrected Visual Acuity (BCVA) of 20/25 Snellen (0.10 logMAR) or better in each eye.
- •Willing to stop wearing habitual contact lenses for the duration of study participation.
- •Other protocol-specific inclusion criteria may apply.
排除标准
- •Any eye infection, inflammation, 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.
- •Habitual wear of AOHP contact lenses.
- •Habitual wear of any daily disposable contact lenses.
- •Other protocol-specified exclusion criteria may apply.
结局指标
主要结局
Least Squares Mean Distance VA With Study Lenses at Week 1
时间窗: Week 1 of each lens product worn during the corresponding crossover period
Visual acuity (VA) was assessed for each eye individually with study lenses in place using logarithmic of the Minimum Angle of Resolution (logMAR) reading charts. LogMAR values typically range from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal distance visual acuity), with a negative value denoting better than 20/20 visual acuity.
次要结局
未报告次要终点