NCT00933166已完成不适用
Assessing the Performance of Lotrafilcon A Lenses During a Three Month Period
CIBA VISION0 个研究点目标入组 169 人开始时间: 2009年6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
- 169
- 主要终点
- Comfort After Insertion
研究概览
简要总结
The purpose of this trial is to assess the performance of an investigational contact lens over a three month period.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •On examination, have ocular findings considered to be "normal," and which would not prevent a participant from safely wearing contact lenses.
- •Be willing and able to follow instructions and meet the schedule of follow-up visits as defined in the informed consent.
- •Be able to wear the study lenses in the available powers.
- •Currently wear contact lenses for a minimum of 5 days a week, and at least 8 hours a day.
- •Other protocol-defined inclusion/
排除标准
- •Exclusion Criteria:
- •Eye injury or surgery within twelve weeks of enrollment.
- •Pre-existing ocular irritation that would preclude contact lens fitting.
- •Currently enrolled in an ophthalmic clinical trial.
- •Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
- •History of corneal refractive surgery.
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Comfort After Insertion
时间窗: 3 months
Comfort after insertion (30 seconds to 1 minute) as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of three months' wear time. Comfort after insertion 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
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