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临床试验/NCT00929487
NCT00929487已完成不适用

Acute Clinical Evaluation of MPS in Soft Contact Lens Wearers

Alcon Research2 个研究点 分布在 1 个国家目标入组 278 人开始时间: 2009年5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
278
试验地点
2
主要终点
Corneal Staining

研究概览

简要总结

The purpose of this study was to clinically evaluate lens care solutions used with soft contact lenses.

详细描述

This study was conducted as a series of ten smaller studies in three countries using commercially available contact lens solutions per each country, ie, United Kingdom, France, and the Philippines. In each study, participants were assessed after use of up to 5 products (with one always being a control saline/blister pack solution) in randomized order in conjunction with one of the silicone hydrogel contact lenses. A total of 278 participants were enrolled in the 10 studies.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Triple (Participant, Investigator, Outcomes Assessor)

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

  • Have read, understood, signed, and dated the written Informed Consent.
  • Be an adapted and successful soft contact lens wearer on a daily wear basis for at least two weeks.
  • Vision correctable to at least 20/30 Snellen.
  • Other protocol-defined inclusion criteria may apply.

排除标准

  • Topical ocular medication use.
  • History of hypersensitivity to any component of the study contact lens care systems.
  • Any slit-lamp finding of abnormal nature at the baseline visit assessment of each study period.
  • Pregnant, lactating, or planning a pregnancy.
  • Other protocol-defined exclusion criteria may apply.

结局指标

主要结局

Corneal Staining

时间窗: 2 hours

次要结局

  • Subjective Comfort(2 hours)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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