NCT02522312已完成不适用
A Retrospective Analysis of Restasis® Benefits in Dry Eye Contact Lens Patients
Hazleton Eye Specialists1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2015年9月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Increased contact lens wear time
研究概览
简要总结
A retrospective analysis of Restasis® benefits in dry eye contact lens patients.
详细描述
Charts of contact lens wearers with diagnosed dry eye who are being treated with Restasis will be evaluated to determine success in treatment by retrospectively looking at various outcome measures including but not limited to schirmer, staining and osmolarity levels
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Male or Female, > or = 18 years of age
- •Subject was previously diagnosed (prior to Baseline Visit) with mild to severe dry eye disease (ITF level 1, 2 or 3) which required continuous medical therapy with Restasis® for a minimum duration of 6 months post-Baseline (Visit 1); or Subject was newly diagnosed (at Baseline Visit) with mild to severe dry eye disease (ITF level 1, 2 or 3) which required continuous medical therapy with Restasis® for a minimum duration of 6 months post-Baseline (Visit 1);
- •Subject was prescribed Restasis® therapy at Baseline Visit (Visit 1) and commenced dosing immediately after Baseline Visit (Visit 1)
- •Baseline Visit occured between 01 July 2012 and 01 January 2014;
- •Subject had corneal staining and at least one dry eye sign (i.e., Schirmer's Test score <10 mm, decreased tear lake, TBUT <10 seconds, conjunctival staining, tear osmolarity >310 mOsmol/L
- •Subject had charted tolerability and efficacy data reflecting at least one follow-up visit following Restasis® treatment initiation; and
- •Subject wore contact lens(es) concurrently while receiving Restasis® treatment for a minimum duration of 6 months post-Baseline (Visit 1)
排除标准
- 未提供
结局指标
主要结局
Increased contact lens wear time
时间窗: 6 months
Improvement of Schirmer's Test score
时间窗: 6 months
次要结局
未报告次要终点
研究者
Dr. Thomas P. Kislan
Doctor at and Owner of Hazleton Eye Specialists
Hazleton Eye Specialists
研究点 (1)
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