NCT01016132已完成不适用
Clinical Evaluation of a Silicone Hydrogel Lens
CIBA VISION0 个研究点目标入组 152 人开始时间: 2009年10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
- 152
- 主要终点
- Overall Preference
研究概览
简要总结
The purpose of this study is to assess the performance of an investigational contact lens among contact lens wearers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Currently wearing lotrafilcon A lenses in both eyes for a minimum of 5 days per week, 8 hours per day, for 3 months.
- •Removes contact lenses daily or sleeps overnight in contact lenses (up to 30 consecutive nights) as prescribed by regular eye care practitioner.
- •Able to achieve distance visual acuity of at least 20/40 in each eye with study lenses.
- •Other protocol inclusion/
排除标准
- •Exclusion Criteria:
- •Eye injury or surgery within 12 months prior to enrollment.
- •Currently enrolled in any clinical trial.
- •History of corneal refractive surgery.
- •Other protocol inclusion/exclusion criteria may apply.
结局指标
主要结局
Overall Preference
时间窗: 4 weeks of wear
Overall preference when comparing study lenses to "habitual" lenses, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of four weeks' wear time. Overall preference was measured on a 5-point Likert scale as follows: Strongly Prefer Study Lenses; Somewhat Prefer Study Lenses; No Preference; Somewhat Prefer "Habitual" Lenses; Strongly Prefer "Habitual" Lenses.
次要结局
未报告次要终点
研究者
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