NCT02258139已完成不适用
The Study to Evaluate the Product Performance 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
- 38
- 试验地点
- 2
- 主要终点
- Percent Change in Central Corneal Thickness
研究概览
简要总结
This will be a randomized non-dispensing study comparing the overnight corneal swelling of an eye while wearing no contact lens to the Ultra contract lens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be between 18 and 40 years of age (inclusive)
- •Not a current contact lens wearer (have not worn extended wear, and not worn in lenses in 6 months)
- •Able to read, comprehend and sign an informed consent
- •Willing to comply with the wear and study visit schedule
- •Monocular best-corrected distance visual acuity >/-20/25 in each eye
排除标准
- •Any active corneal infection, disease, injury, inflammation, past surgery, or ocular abnormality which may interfere with contact lens wear
- •Systemic or ocular allergies, which might interfere with contact lens wear
- •Systemic disease or condition, which might interfere with contact lens wear
- •Use of prescription sleep aids or alcohol within 24 hours of study appointment
- •Inability to wear contact lenses
- •Under 18 years of age
结局指标
主要结局
Percent Change in Central Corneal Thickness
时间窗: 8 hours
Percent change in central corneal thickness from evening to morning (after 8 hours with lid closed)
次要结局
- Time to Restore Central Corneal Thickness(48 hours)
研究者
研究点 (2)
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