A Three-Month Safety Study to Determine the Retention Times of Side-Arm Canalicular Stents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Mean Retention Time
研究概览
简要总结
The purpose of this study was to determine the safety and retention times of two different lengths (10 mm and 20 mm) of the MINI MONOKA canicular stent when inserted in the eye for up to three months in subjects with or without dry eye.
详细描述
This study consisted of 6 visits conducted over a period of 3 months. At Visit 1 (Day 0), the canalicular stent was inserted. If the stent insertion failed, the subject was rescheduled for insertion at the Day 2 visit. If the stent insertion was not successfully completed by the end of the Day 2 visit, the subject was discontinued from the study. Any subject who had the stent inserted but lost the stent (noticed or unnoticed) after the Day 2 Visit was considered to have completed the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sign Informed Consent.
- •With or without dry eye.
- •Willing to discontinue contact lenses during the study.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Chronic, recurrent, or severe inflammatory eye disease.
- •Ocular trauma within the past 6 months.
- •Ocular hypertension or glaucoma.
- •History of punctal plug/canalicular stent insertion.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Mean Retention Time
时间窗: From baseline (Day 0) up to Month 3
At all study visits the investigator conducted a slit lamp examination to determine whether the canalicular stent was present.
次要结局
- Percentage of Subjects Retaining the Stent at Month 3(Month 3)