Clinical Evaluation of a Silicone Hydrogel Lens

CIBA VISION0 个研究点目标入组 152 人2009年10月

适应症Myopia

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Myopia
发起方: CIBA VISION
入组人数: 152
主要终点: Overall Preference
状态: 已完成
最后更新: 13年前

概览研究者入排标准结局指标相似试验

概览

简要总结

The purpose of this study is to assess the performance of an investigational contact lens among contact lens wearers.

注册库

clinicaltrials.gov

开始日期

2009年10月

结束日期

2009年12月

最后更新

13年前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

CIBA VISION

责任方

Sponsor

入排标准

入选标准

•Currently wearing lotrafilcon A lenses in both eyes for a minimum of 5 days per week, 8 hours per day, for 3 months.
•Removes contact lenses daily or sleeps overnight in contact lenses (up to 30 consecutive nights) as prescribed by regular eye care practitioner.
•Able to achieve distance visual acuity of at least 20/40 in each eye with study lenses.
•Other protocol inclusion/exclusion criteria may apply.

排除标准

•Eye injury or surgery within 12 months prior to enrollment.
•Currently enrolled in any clinical trial.
•History of corneal refractive surgery.
•Other protocol inclusion/exclusion criteria may apply.

结局指标

主要结局

Overall Preference

时间窗: 4 weeks of wear

Overall preference when comparing study lenses to "habitual" lenses, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of four weeks' wear time. Overall preference was measured on a 5-point Likert scale as follows: Strongly Prefer Study Lenses; Somewhat Prefer Study Lenses; No Preference; Somewhat Prefer "Habitual" Lenses; Strongly Prefer "Habitual" Lenses.