Acute Clinical Evaluation of MPS in Soft Contact Lens Wearers

Alcon Research1 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1日最近更新: 2012年9月10日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Alcon Research
入组人数: 278
试验地点: 1
主要终点: Corneal Staining

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

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: 否

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.

研究组 & 干预措施

Contact lens solution #1

Experimental

干预措施: Contact lens multi-purpose solution (Device)