NCT01097863已完成不适用
Clinical Validation of the New Print on Focus DAILIES Toric
CIBA VISION0 个研究点目标入组 280 人开始时间: 2010年3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
- 280
- 主要终点
- Visibility of the Inversion Indicator on Lens When Lens Was on Participant's Finger, for Example, During Lens Insertion.
研究概览
简要总结
The purpose of this study is to validate the improvements to the inversion indicator.
详细描述
This study was conducted in three countries under three separate protocols: P-346-C-009 sub 02 (UK), P-346-C-009 sub 03 (Germany), and P-346-C-010 (USA). The data reported represents pooled data from the three protocols.
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
- •Be of legal age and sign written Informed Consent Document. If under legal age, parent or guardian must sign Informed Consent Document and subjects ages 12 through 17 must sign Informed Assent.
- •Willing and able to wear study lenses in both eyes in the available parameters.
- •Light-eyed subjects.
- •Able to achieve 20/40 or better distance visual acuity (VA) in each eye at time of dispensing.
- •Optimal or acceptable fit in each eye at time of dispensing.
- •Willing to wear the study lenses at least 8 hours a day, 5 days a week.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Eye injury or surgery within twelve weeks prior to enrollment for this trial.
- •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 which is likely to affect successful wear of contact lenses or use of their accessory solutions as determined by the investigator.
- •Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
- •RGP contact lens wearer.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Visibility of the Inversion Indicator on Lens When Lens Was on Participant's Finger, for Example, During Lens Insertion.
时间窗: 1 week
As assessed by the participant retrospectively after one week of wear and recorded on a questionnaire as a yes or no response to the question, "Did you notice an OK mark on the study lens while it was on your finger, for example, during lens insertion?" The positive "yes" responses are reported.
次要结局
未报告次要终点
研究者
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