NCT00691197已完成2 期
Safety and Acceptability of Using a Rewetting Drop With Contact Lens Wear
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 246
- 试验地点
- 1
- 主要终点
- Best Corrected Visual Acuity
研究概览
简要总结
Testing the Safety and Acceptability of Using a Rewetting Drop with Contact Lenses
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 是
入选标准
- •Adapted contact lens wearer
排除标准
- •Monovision lens wearer, ocular or systemic disease, pregnant or planning to become pregnant
研究组 & 干预措施
Carboxymethylcellulose sodium
Active Comparator
Carboxymethylcellulose sodium based rewetting drop
干预措施: Carboxymethylcellulose sodium (Device)
Carboxymethylcellulose sodium and Glycerin
Experimental
Carboxymethylcellulose sodium and Glycerin based rewetting drop
干预措施: Carboxymethylcellulose sodium and Glycerin (Device)
结局指标
主要结局
Best Corrected Visual Acuity
时间窗: Change from Baseline at Day 90
Percentage of Subjects Tabulated by Changes in Line Number at Day 90 from Baseline; Visual Acuity measured by LogMar reported as Snellen equivalents. Better: an increase of 2 lines or more in at least one eye; No Change: a change less than +/- 2 lines in both eyes; Worse: a decrease of 2 lines or more in at least one eye.
次要结局
- Corneal Staining(Day 90)
研究者
研究点 (1)
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