跳至主要内容
临床试验/NCT00810511
NCT00810511已完成不适用

Evaluation of Two Silicone Hydrogel Lenses Over a One Month Period

CIBA VISION0 个研究点目标入组 213 人开始时间: 2008年11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
213
主要终点
Comfort at End of Day

研究概览

简要总结

The purpose of this trial is to compare two different contact lenses during 4 weeks of wear.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Current soft contact lens wearer who wear their habitual lenses for no less than 10 hours a day, 5 days a week
  • Have a need for correction in both eyes and be correctable to at least 20/40 distance vision in each eye while wearing trial lenses
  • Replace lenses on a weekly or longer schedule
  • Other protocol inclusion/

排除标准

  • Exclusion Criteria:
  • Requires concurrent ocular medication
  • Eye injury or surgery within twelve weeks immediately prior to enrollment
  • Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of their accessory solutions
  • Current soft toric lens wearers
  • Those who dispose of their soft lenses on a daily basis
  • Current NIGHT & DAY® or Biofinity® lens wearers
  • Other protocol-defined inclusion/exclusion criteria may apply

结局指标

主要结局

Comfort at End of Day

时间窗: After 4 weeks of wear

Evaluated by the subject as a single, retrospective evaluation of 4-week wear time. Measured on a 10-point scale, with 1 being poor and 10 being excellent.

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

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