NCT00789529已完成不适用
Objective Testing of Tear Film Stability
Manhattan Vision Associates2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2008年9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
- 32
- 试验地点
- 2
- 主要终点
- Objective, In-vivo Soft Contact Lens Wettability Index
研究概览
简要总结
The purpose of this study is to evaluate the in-vivo wettability of soft contact lenses when cared with two different multi-purpose solutions over a two week wearing period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject must be at least 18 years of age and no more than 80 years of age.
- •The subject must have a best corrected visual acuity of 20/30 or better for each eye.
- •The subject must habitually wear contact lenses.
- •The subject must have had an eye exam within the last 12 months. The exam data must be available to the investigators prior to the first visit.
- •The subject must have normal eyes, no use of ocular medications, no ocular infection of any type, and no ocular inflammation.
- •The subject must read understand and sign the Statement of Informed Consent.
- •The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
排除标准
- •Ocular or systemic allergies or disease that might interfere with contact lens wear.
- •Systemic disease, autoimmune disease or use of medication which might interfere with contact lens wear.
- •Clinically significant (FDA Scale grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormalities of the cornea which would contraindicate contact lens wear.
- •Clinically significant (FDA Scale grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
- •Any ocular infection.
- •Pregnancy or lactation.
- •Infectious diseases (e.g. hepatitis, tuberculosis)
- •Contagious immunosuppressive diseases (e.g. HIV)
结局指标
主要结局
Objective, In-vivo Soft Contact Lens Wettability Index
时间窗: 2 weeks
The wettability index is derived from the slope of a metric developed to measure the regularity of the Shack-Hartmann wavefront sensor image. The more wettable a lens is the more stable the metric and the slope of the metric (the wettability index) is closer to zero. The more negative values indicate a less wettable the lens.
次要结局
- Subject Questionnaire Response(2 weeks)
研究者
研究点 (2)
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