NCT01309100已完成不适用
A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Contact Lens
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Visual Acuity (Investigational vs Air Optix Aqua Lens)
研究概览
简要总结
The objective of this study is to determine the clinical feasibility and to evaluate the product performance of investigational contact lens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must have clear central corneas and be free of any anterior segment disorders.
- •Subjects must be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
- •Subjects must be myopic and require lens correction
排除标准
- •Subjects with any systemic disease affecting ocular health.
- •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 are using any ocular medication.
- •Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
结局指标
主要结局
Visual Acuity (Investigational vs Air Optix Aqua Lens)
时间窗: 1 week
The mean difference in distance high contrast logMAR visual acuity(VA) between the investigational lens (RD2117-01) and the Air Optix Aqua control lens.
Visual Acuity (Investigational vs Acuvue Oasys Lens)
时间窗: 1 week
The mean difference in distance high contrast logMAR visual acuity(VA) between the investigational lens(RD2117-01) and the Acuvue Oasys control lens.
次要结局
- Comfort Throughout the Day (Investigational vs Acuvue Oasys Lens)(1 week)
- Comfort Throughout the Day (Investigational vs Air Optix Aqua Lens)(1 week)
研究者
研究点 (2)
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