NCT00985231已完成不适用
Performance Evaluation of Contact Lenses Among a Population of Adapted Contact Lens Wearers
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 272
- 试验地点
- 1
- 主要终点
- Distance Visual Acuity (VA) Between Test and Control Lenses Worse Than 20/40.
研究概览
简要总结
This study is being conducted to evaluate Bausch & Lomb PureVision Multi-Focal contact lenses compared to the Bausch & Lomb SofLens59 contact lens when worn by adapted soft contact lens wearers on a daily wear basis.
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
- 年龄范围
- 30 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have clear central corneas and be free of any anterior segment disorders.
- •Subjects must be adapted soft contact lens wearers and agree to wear the study lenses on a daily wear basis for at least eight hours a day for approximately two weeks.
- •Subjects must wear a lens in each eye and each lens must be of the same manufacture and brand.
排除标准
- •Subjects participating in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation.
- •Subjects with any systemic disease affecting ocular health
- •Subjects with an active ocular disease or using any ocular medication.
- •Subjects who have had any corneal surgery (eg, refractive surgery).
研究组 & 干预措施
SofLens59 contact lens
Active Comparator
干预措施: SofLens59 contact lens (Device)
PureVision Multi-Focal contact lenses
Experimental
干预措施: PureVision Multi-Focal contact lenses (Device)
结局指标
主要结局
Distance Visual Acuity (VA) Between Test and Control Lenses Worse Than 20/40.
时间窗: 2 weeks
Eyes with distance lens VA of 20/40 or worse at study exit between test and control lenses.
次要结局
- Subjective Ratings of Eye Strain(2 week visit)
研究者
研究点 (1)
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