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临床试验/NCT01010555
NCT01010555已完成不适用

In-vivo Wettability Grading and Assessment Study

CIBA VISION2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2009年10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
25
试验地点
2
主要终点
On-eye Wettability

研究概览

简要总结

The purpose of this study is to investigate the front surface wettability of soft contact lenses while on eye.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

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

入选标准

  • is at least 17 years of age
  • has read and signed an information consent letter
  • is a current daily wear contact lens wearer
  • has acceptable fit with the study lenses
  • has had an ocular exam in the last two years
  • other protocol-defined inclusion criteria may apply

排除标准

  • has any ocular disease
  • has undergone corneal refractive surgery or is aphakic
  • has any systemic disease affecting ocular health
  • is pregnant or lactating
  • other protocol-defined exclusion criteria may apply

结局指标

主要结局

On-eye Wettability

时间窗: 4 weeks of wear

On-eye wettability, as assessed at the 4-week visit by a masked observer from a video taken of the eye 5 minutes after lens insertion. On-eye wettability was recorded on a 5-point scale, with 0=excellent and 4=very poor.

次要结局

未报告次要终点

研究者

发起方
CIBA VISION
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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