NCT01035905已完成不适用
Comparative Clinical Evaluation of Daily Disposable Lenses in Symptomatic Daily Disposable Lens Wearers
CIBA VISION0 个研究点目标入组 63 人开始时间: 2009年9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
- 63
- 主要终点
- Lens Awareness
研究概览
简要总结
The purpose of this study is to evaluate the extent to which symptoms improve in symptomatic contact lens wearers when fit with one of two different daily disposable contact lenses.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Currently wear daily disposable, spherical, soft lens wearers (except the two study products) for at least the past 6 months.
- •Habitually wear lenses for at least 8 hours per day and 4 days per week.
- •Report 2 or more qualifying symptoms with current contact lenses.
- •Able to achieve visual acuity of at least 20/40 in each eye with habitual and with study lenses at dispense.
- •Other protocol-defined inclusion/
排除标准
- •Exclusion Criteria:
- •Eye injury or surgery within twelve weeks immediately prior to enrollment.
- •Currently enrolled in any clinical trial.
- •Any use of ocular medications, exclusive of contact lens rewetting drops.
- •History of corneal or refractive surgery.
- •Cylinder correction greater than 1.00 D
- •Current monovision contact lens wearers.
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Lens Awareness
时间窗: 4 weeks of wear
Lens awareness, as interpreted by the subject and reported by the subject in a questionnaire as a single, retrospective evaluation of 4-week's wear time. Frequency of lens awareness was measured on a 4-point scale, with 1 being never and 4 being always. Four-week ratings were compared to baseline ratings, and a negative difference (4 week minus baseline) represented an improvement.
次要结局
未报告次要终点
研究者
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