NCT01295905已完成不适用
Prospective Study of an Investigational Daily Disposable Contact Lens
CIBA VISION0 个研究点目标入组 90 人开始时间: 2011年1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
- 90
- 主要终点
- Corrected Distance Monocular Visual Measurement in Normal Illumination Reported as Visual Acuity
研究概览
简要总结
The purpose of this study is to evaluate the performance of an investigational daily disposable contact lens.
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
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with normal eyes who are not using any ocular medications.
- •Be of legal age of consent and sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and subject must sign Assent document.
- •Willing and able to wear spherical contact lenses for at least 5 days per week.
- •Willing and able to wear spherical contact lenses within the available range of powers of -1.00 diopter(D) to -6.00D in 0.25D steps.
- •Best spectacle-corrected visual acuity greater than or equal to 20/
- •Manifest cylinder less than or equal to 0.75D.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Any active anterior segment ocular disease that would contraindicate contact lens wear.
- •Any use of systemic medications for which contact lens wear could be contraindicated as determined by the investigator.
- •History of refractive surgery or irregular cornea.
- •History of pathologically dry eye.
- •Eye injury within twelve weeks immediately prior to enrollment for this trial.
- •Currently enrolled in any clinical trial.
- •Participation in a contact lens or contact lens care product clinical trial within the previous 30 days.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Corrected Distance Monocular Visual Measurement in Normal Illumination Reported as Visual Acuity
时间窗: 3 months of wear, lenses replaced daily
Each eye tested individually while reading a chart distant to the participant in normal lighting. Visual acuity was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. Visual acuity is reported as the number of eyes achieving 20/20 Snellen acuity or better.
次要结局
- Overall Handling(3 months of wear, lenses replaced daily)
- Overall Comfort(3 months of wear, lenses replaced daily)
- Overall Vision(3 months of wear, lenses replaced daily)
研究者
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