NCT01449526已完成不适用
A Study to Evaluate the Safety and Efficacy of a New Silicone Hydrogel Contact Lens Design
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 166
- 主要终点
- Visual Acuity (VA)
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of a new silicone hydrogel contact lens compared to the Bausch + Lomb PureVision contact lens when worn by adapted soft contact lens wearers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 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 myopic, and wear contact lenses in each eye.
- •Subjects must be adapted soft contact lens wearers and agree to wear their study lenses on a daily wear basis for approximately 3 months.
排除标准
- •Subjects who are older than age 40 on the date the informed consent (ICF) is signed.
- •Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.
- •Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
- •Subjects with an active ocular disease or who are using any ocular medication.
- •Subjects with any grade 2 or greater finding during the slit lamp examination.
- •Subjects with corneal infiltrates, of ANY GRADE, are not eligible.
- •Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- •Subjects who are allergic to any component in the study care products.
结局指标
主要结局
Visual Acuity (VA)
时间窗: 4 visits over 3 months
Mean high contrast, distance logMAR VA for each eye between the Test and Control lenses. This measure is an average from 4 visits taking place over 3 months.
次要结局
- Slit Lamp > Grade 2(3 months)
研究者
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