NCT00934102已完成不适用
Ophthalmic Compatibility During Seven Days of Continuous Wear of Silicone Hydrogel Lenses (P/318/08/C)
CIBA VISION2 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2009年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Front Surface Lens Deposits
研究概览
简要总结
The purpose of this study is to assess the ophthalmic compatibility of three different silicone hydrogel lenses worn on an overnight basis for six nights.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is at least 17 years of age and has full legal capacity to volunteer
- •Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual vision correction
- •Has had an ocular examination in the last two years
- •Is a current soft (hydrogel or silicone hydrogel) contact lens wearer
- •Has clear corneas and no active ocular disease
- •Can be successfully fit with the lenses to be used in the study
- •Other protocol-defined inclusion/
排除标准
- •Exclusion Criteria:
- •Is pregnant or lactating
- •Has undergone corneal refractive surgery
- •Currently wears lenses on an extended wear basis or was on extended wear within six months prior to the study
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
Front Surface Lens Deposits
时间窗: Period 2, Day 6
Protein and lipid deposits on the contact lens surface as assessed by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits were graded on a scale of 0 to 4 with 0 being none and 4 being severe.
次要结局
未报告次要终点
研究者
研究点 (2)
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