NCT00965237已完成不适用
P/331/09/C: Multifocal Pilot Study: Refitting Drop Outs (GARM)
CIBA VISION2 个研究点 分布在 1 个国家目标入组 16 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
- 16
- 试验地点
- 2
- 主要终点
- Overall Satisfaction With the Lenses
研究概览
简要总结
The purpose of this study is to evaluate the use of a multifocal contact lens in people who previously wore contact lenses but discontinued due to age-related, near vision demands.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •has discontinued contact lens wear primarily due to age-related, near vision demands
- •requires a reading add of +0.50 to +1.75 D (inclusive) and is correctable to at least 6/9 monocular, distance and near with spectacle correction
- •has had an ocular examination in the last 2 years
- •Other protocol-defined inclusion/
排除标准
- •Exclusion Criteria:
- •has any ocular disease
- •has more than a 2.00D prescription difference between eyes
- •cannot be fit successfully with the study contact lenses
- •has any systemic disease affecting ocular health
- •is using any systemic or topical medications that may affect ocular health
- •has undergone corneal refractive surgery
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
Overall Satisfaction With the Lenses
时间窗: 1 week of wear
Overall satisfaction with the lenses was interpreted by and assessed by the subject as a single, retrospective measurement of one week's wear time. Overall satisfaction with the lenses was recorded on a questionnaire as a numerical rating on a scale of 1 to 100, with 1 being completely dissatisfied, and 100 being excellent, completely satisfied.
次要结局
未报告次要终点
研究者
研究点 (2)
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