NCT00953407已完成不适用
Comparative Clinical Evaluation of Daily Disposable Lenses in Symptomatic Lens Wearers
CIBA VISION0 个研究点目标入组 128 人开始时间: 2009年7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
- 128
- 主要终点
- Lens Awareness
研究概览
简要总结
The purpose of this trial is to evaluate the extent to which symptoms improve in symptomatic contact lens wearers when fit with one of 5 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 spherical, soft contact lenses replaced at intervals of 2 weeks or monthly.
- •Habitually wear lenses for at least 8 hours per day, 4 days per week, for at least the past 6 months.
- •Report 2 or more qualifying symptoms with current contact lenses with a frequency of "frequently" or "all the time"
- •Able to achieve VA of at least 20/40 in each eye with habitual correction and with study lenses at dispense.
- •Other protocol 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 medications for which contact lens wear could be contraindicated as determined by the investigator.
- •History of corneal refractive surgery.
- •Cylinder correction greater than 1.00 D.
- •Current monovision contact lens wearers.
- •Other protocol 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, was reported by the subject 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 all the time. 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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