NCT00399061已完成4 期
Efficacy of Optive Versus Systane 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
- 55
- 试验地点
- 1
- 主要终点
- Efficacy
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of Optive versus Systane used concomitantly with topical cyclosporine for the treatment of dry eye.
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
- Double (Participant, Investigator)
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
- •Score of at least 2 and no more than 4 on the SESOD at the initial screening visit (mild to severe patients)
- •At least Grade 2 conjunctival staining
- •Likely to complete all study visits and able to provide informed consent
排除标准
- •· Prior unsuccessful use of topical cyclosporine (defined as patients taking it at least 3 months and saw no improvements)
- •Current use of topical cyclosporine
- •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.
- •Planned use of contact lenses (unless discontinued use ³ 30 days prior to randomization)
- •Active ocular diseases or uncontrolled systemic disease (blepharitis patients that are actively being treated or disease that is uncontrollable)
- •Ocular surgery within the past 3 months,
- •Active ocular allergies
研究组 & 干预措施
1
Active Comparator
Systane
干预措施: Systane, Optive, Restasis (Drug)
2
Active Comparator
Optive
干预措施: Systane, Optive, Restasis (Drug)
3
Placebo Comparator
Restasis
干预措施: Systane, Optive, Restasis (Drug)
结局指标
主要结局
Efficacy
时间窗: 1 yr 3 months
次要结局
- Dry eye symptoms(1yr 3 months)
研究者
研究点 (1)
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