NCT01416142已完成不适用
A Study to Evaluate the Product Performance of the PureVision®2 HD Contact Lens
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Visual Acuity
研究概览
简要总结
The objective of this study is to evaluate the product performance of PureVision2 HD 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
- None
入排标准
- 年龄范围
- 15 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings
- •Subjects must be myopic or hyperopic and require lens correction in each eye
- •Subjects must own a pair of spectacles and the spectacle prescription must have been updated or confirmed as correct within the last 2 years.
排除标准
- •Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- •Any systemic disease affecting ocular health.
- •Using any systemic or topical medications that will affect ocular physiology or lens performance.
- •Allergic to any component in the Biotrue multi-purpose solution
结局指标
主要结局
Visual Acuity
时间窗: Screening visit (Visit 1) and one week follow-up(Visit 3)
Visual acuity(VA) measured at the screening visit (all eligible participants) while wearing spectacles and the VA measured at the end of study (Visit 3) 1-Week wearing PureVision2 HD lenses. VA wearing spectacles vs. VA wearing PureVision2 HD Lenses, lower the number the better the VA.
次要结局
- Preference for Test Lens(During the movie (Visit 2))
研究者
研究点 (2)
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