NCT00405457已完成4 期
Efficacy and Safety of a New Multi-dose Lubricant Eye Drop Concomitant With Restasis® (Cyclosporine A) for the Treatment of Dry Eye Symptoms
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- efficacy
研究概览
简要总结
To evaluate the efficacy, safety and tolerability of a combination of Optive® Artificial Tears with Restasis®.The primary hypothesis is that the Ocular Surface Disease Index (OSDI) score and symptoms will be the same or lower than baseline after treatment in these patients. The patients will tolerate the combination of Restasis® and Optive® with a low incidence of clinical adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •· Males or females > 18 years old
- •Patients currently taking Restasis® for at least 3 months in duration and using artificial tears as needed for dry eye.
- •Likely to complete all study visits and able to provide informed consent
排除标准
- •· Patients using Restasis® for less than 3 months.
- •Known contraindications to any study medication or ingredients
- •Female of child bearing potential not using reliable methods of birth control, or pregnant or lactating females.
- •Other active uncontrolled ocular diseases or uncontrolled systemic disease
研究组 & 干预措施
A
Other
干预措施: Restasis, Optive Tears (Drug)
结局指标
主要结局
efficacy
时间窗: 1 yr 3 months
次要结局
- dry eye symptoms(1 yr 3 months)
研究者
研究点 (1)
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