NCT01311609已完成4 期
Multi-Site Post Marketing Surveillance Study for Systane in Indian Patients
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 300
- 主要终点
- Best-corrected visual acuity
研究概览
简要总结
This study is a multi-site, unmasked PMS Study. The purpose of the study is to evaluate the physical effects of Systane Lubricant Eye Drops.
详细描述
This study is a multi-site, unmasked PMS Study. The purpose of the study is to evaluate the physical effects of Systane Lubricant Eye Drops. The assessed effects include: corneal and conjunctival staining, and ocular signs and symptoms. This is a two week prospective study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •18 years of age or older, of both sexes, and any race.
- •Willing and able to make all required visits and follow study instructions.
- •A sodium fluorescein corneal staining sum of >/ 3 in either eye. A best-corrected visual acuity of 0.6 log MAR or better in each eye as assessed during an ETDRS chart
排除标准
- •A history or evidence of ocular or intraocular surgery in either eye within the past 6 months.
- •Lasik patients can be included if Lasik surgery was > 6 months prior to the initiation of the study.
- •A history of intolerance or hypersensitivity to any component of the study medications.
结局指标
主要结局
Best-corrected visual acuity
时间窗: Visit 2 (Week 2) - change from baseline
Corneal Staining
时间窗: Visit 2 (Week 2) - change from baseline
次要结局
未报告次要终点
研究者
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