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
- 68
- 试验地点
- 10
- 主要终点
- Visual Acuity With Study Lenses at Week 1 Follow-Up
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 study lens type for approximately 14 days and attend 7 scheduled visits. The expected duration of subject participation in the study is approximately 28 days (approximately 14 days per each study lens type).
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 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-specified 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
Visual Acuity With Study Lenses at Week 1 Follow-Up
时间窗: Week 1, each wear period. A wear period was approximately 14 days.
Visual acuity (VA) was assessed with study lenses in place 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. Each eye was assessed individually. No hypothesis testing was pre-specified for this endpoint.
次要结局
未报告次要终点