跳至主要内容
临床试验/NCT01185834
NCT01185834已完成不适用

Assessment of Lotrafilcon A Contact Lenses

CIBA VISION0 个研究点目标入组 118 人开始时间: 2010年7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
118
主要终点
Overall Comfort

研究概览

简要总结

The purpose of this 3-month study is to evaluate subjective responses to an upgraded contact lens.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • Have normal ocular findings.
  • Be able to wear the study lenses in the available powers.
  • Currently wear contact lenses for a minimum of 5 days a week, and at least 8 hours a day.
  • Wear Night & Day contact lenses.
  • Other protocol-defined inclusion criteria may apply.

排除标准

  • Require concurrent ocular medication.
  • Eye injury or surgery within twelve weeks prior to enrollment.
  • Currently enrolled in an ophthalmic clinical trial.
  • Any active corneal infection.
  • Corneal refractive surgery.
  • Wear AIR OPTIX NIGHT & DAY AQUA lenses.
  • Other protocol-defined exclusion criteria may apply.

结局指标

主要结局

Overall Comfort

时间窗: 3 months of wear, replacing lenses monthly

As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.

次要结局

  • Overall Lens Fit(3 months of wear, replacing lenses monthly)

研究者

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

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