NCT00987623已完成不适用
Clinical Evaluation of Two Daily Disposable Lenses in Neophytes
CIBA VISION2 个研究点 分布在 1 个国家目标入组 326 人开始时间: 2009年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 326
- 试验地点
- 2
- 主要终点
- Overall Lens Satisfaction
研究概览
简要总结
The purpose of this study is to evaluate the performance of two daily disposable contact lenses in a population of neophytes (new wearers).
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
- None
入排标准
- 年龄范围
- — 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No previous contact lens experience or attempts to try contact lenses (neophytes).
- •Currently wearing spectacles or needing vision correction in both eyes.
- •No older than 45 years of age.
- •Able to achieve visual acuity of at least 20/40 in each eye with study lenses in the available parameters.
- •Interested in wearing contact lenses.
- •Willing to wear study lenses for at least 8 hours/day, at least 5 days/week.
- •Other protocol-defined inclusion/
排除标准
- •Exclusion Criteria:
- •Eye injury or surgery within twelve weeks prior to enrollment.
- •Pre-existing ocular irritation that would preclude contact lens fitting.
- •Previous corneal or refractive surgery.
- •Currently enrolled in any Clinical Trial.
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Overall Lens Satisfaction
时间窗: 1 week
Overall Lens Satisfaction, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of 1-week's wear time. Overall lens satisfaction was measured on a 10-point scale, with 1 being Poor and 10 being Excellent
次要结局
未报告次要终点
研究者
研究点 (2)
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