NCT01539694已完成不适用
A Study to Evaluate the Product Performance of a Low Add MultiFocal Soft Contact Lens
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 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 an investigational multifocal low add soft contact lens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have physiologically normal anterior segments.
- •Be adapted wearers of soft contact lenses and wear a lens in each eye.
- •Be presbyopic and require near add correction in each eye.
- •Have no active ocular disease or allergic conjunctivitis.
- •Must not be using any topical ocular medications.
排除标准
- •Any Grade 2 or greater finding during the slit lamp examination.
- •Any scar or neovascularization within the central 4mm of the cornea.
- •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 products.
- •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.
结局指标
主要结局
Visual Acuity
时间窗: At 1 week follow up
Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).
次要结局
- Symptoms/Complaints(At 1 week follow up)
研究者
研究点 (2)
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