NCT00909792已完成不适用
Clinical Evaluation of Two New Silicone Hydrogel Multifocal Products
CIBA VISION0 个研究点目标入组 259 人开始时间: 2009年5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
- 259
- 主要终点
- Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity
研究概览
简要总结
The objective of this trial is compare the visual performance, ratings, and preference of two multifocal, soft contact lenses.
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
- Single (Participant)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be at least 35 years of age
- •Best-corrected distance visual acuity of at least 20/40 in each eye.
- •Spectacle add between +0.75D and +1.50D (inclusive).
- •Able to be fit in available study sphere powers (-1.00 to -5.00D)
- •Currently wearing soft contact lenses at least 5 days a week.
- •Other protocol inclusion/
排除标准
- •Exclusion Criteria:
- •Eye injury or surgery within twelve weeks immediately prior to enrollment.
- •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.
- •Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
- •Astigmatism ≥ 1.00D.
- •Currently wearing either of the study products.
- •Other protocol inclusion/exclusion criteria may apply.
结局指标
主要结局
Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity
时间窗: After 1 week of wear
Tested while reading charts distant to the subject with both eyes together in normal lighting. This outcome is measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 equates to 20/20 Snellen acuity and is considered normal. Positive logMAR values indicate poorer vision and negative values denote better visual acuity.
次要结局
未报告次要终点
研究者
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