NCT01309880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
- 66
- 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 determine the clinical feasibility and to evaluate the product performance of investigational contact lenses developed by Bausch + Lomb.
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
- •Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
- •Be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
排除标准
- •Have worn gas permeable (GP) contact lenses within last 30 days or polymethylmethacrylate (PMMA) lenses within last 3 months.
- •Any systemic disease affecting ocular health.
- •Using any systemic or topical medications that will affect ocular physiology or lens performance.
- •An active ocular disease, any corneal infiltrative response or are using any ocular medications.
- •Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- •Allergic to any component in the study care products.
结局指标
主要结局
Visual Acuity
时间窗: Dispensing & 1-week follow up
Distance high contrast logMAR lens visual acuity (VA) between the Air Optix Aqua lens and the Test Lens at Dispensing and at 1-Week Follow-up.
次要结局
- Slit Lamp Findings(1 week)
- Comfort(1 Weeks)
研究者
研究点 (2)
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