A Single-Center Study Evaluating the Effect of the Controlled Adverse Environment (CAE) on Tear Film Stability Using the OPI 2.0 System, Ocular Protection Index (OPI), Tear Film Break-Up Time (TFBUT) and Mean Break up Area by Region (MBA) in Patients Diagnosed With Dry Eye Evaluated During Their Natural Blink Pattern
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- change in tear film break up area
研究概览
简要总结
The purpose of this study is to evaluate the effect of the controlled adverse environment (CAE) on Mean Break-Up Area in subjects diagnosed with Dry Eye Syndrome.
详细描述
Single-Center, Pilot, controlled adverse environment (CAE) Study.
This is a single-center, one visit, pilot, CAE study. Dry Eye Subjects (N=30) who qualify will undergo tear film video recording, fluorescein staining, and break up time before CAE exposure and after CAE exposure.
All subjects will undergo baseline dry eye assessments including fluorescein staining, breakup time, conjunctival redness and tear film video recording. Subjects who qualify will then undergo CAE exposure for 90 minutes. At the end of CAE exposure subjects will undergo dry eye assessments again.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- •At least 18 years of age & either sex, any race
- •Willing and able to follow all instructions
- •Positive history of dry eye disease
- •Use or desire to use drops for dry eye within the past 6 months
排除标准
- •Have planned surgery during trial period
- •Female currently pregnant, planning a pregnancy or lactating
- •Use of disallowed medications
- •Have ocular infections, or ocular conditions that could affect study parameters
- •Have used an investigational drug or device within 30 days of start of study
- •Female that is currently pregnant, planning a pregnancy or lactating
结局指标
主要结局
change in tear film break up area
时间窗: change from baseline in tear film break up area at 30 minutes post-CAE at study visit
次要结局
- change in Fluorescein Staining(change from baseline in staining at 30 minutes post-CAE)
- Change in Tear film break up time (TFBUT)(change from baseline in tear film break up time at 30 minutes post-CAE)
- Change in Conjunctival Redness(change from baseline in conjunctival redness at 30 minutes post-CAE)