跳至主要内容
临床试验/NCT01155726
NCT01155726已完成不适用

The Effect of Masking on Subjective Results During Daily Disposable Contact Lens Studies

CIBA VISION2 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2010年5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
134
试验地点
2
主要终点
Average Subjective Comfort

研究概览

简要总结

The purpose of this study is to explore the effect of masking on subjective ratings for two daily disposable contact lenses.

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
Single (Participant)

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

  • 17 years of age or older.
  • Ocular exam within 2 years.
  • Currently wearing soft contact lenses on a daily wear basis.
  • Contact lens prescription between +6.00D and -10.00D.
  • Other protocol-defined inclusion criteria may apply.

排除标准

  • Any ocular disease.
  • Use of systemic or ocular medications that may affect ocular health.
  • Unable to achieve an acceptable fit with the study lenses.
  • Anisometropia >1.00D or astigmatism >0.75D.
  • Other protocol-defined exclusion criteria may apply.

结局指标

主要结局

Average Subjective Comfort

时间窗: Insertion, 4 hours, 8 hours each: Day 1, Day 2, and Day 3

Participants were asked, "How would you rate your comfort with your study lenses?" and indicated their response by marking a continuum line ranging from 0=very poor comfort to 100=excellent comfort. Subjective comfort was collected at three time points (insertion, 4 hours, 8 hours) for 3 days, and the comfort ratings were averaged together.

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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