跳至主要内容
临床试验/NCT00784641
NCT00784641已完成不适用

A Product Performance Evaluation of a Novel Contact Lens for Daily Disposable Use

Bausch & Lomb Incorporated2 个研究点 分布在 1 个国家目标入组 567 人开始时间: 2008年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
567
试验地点
2
主要终点
Percentage of Participants With Favorable Responses for the Initial Lens Performance Survey

研究概览

简要总结

Evaluation of the clinical performance of a novel Bausch & Lomb daily disposable contact lens when compared to the currently marketed Bausch & Lomb SofLens® daily disposable contact lenses and the currently marketed Johnson and Johnson 1-Day Acuvue Moist contact lenses when worn by adapted soft contact lens wearers on a daily disposable basis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

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

  • Subjects with VA correctable to 0.3 logMAR (driving vision) or better in each eye.
  • Subjects must have clear central corneas and be free of any anterior segment disorders.
  • Subjects must be myopic and require lens correction in both eyes.

排除标准

  • Subjects with any systemic disease affecting ocular health.
  • Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
  • Subjects wearing monovision, multifocal or toric contact lenses.
  • Subjects with grade 2 or greater slit lamp findings.

结局指标

主要结局

Percentage of Participants With Favorable Responses for the Initial Lens Performance Survey

时间窗: At dispensing

The initial lens performance survey was administered at the Screening/Dispensing Visit. Scores were captured on a scale from 0 to 100, with 100 being the most favorable score. Favorable responses were defined as scores of 80 or greater.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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