NCT00520260已完成4 期
Bromfenac 0.09% vs. Ketorolac 0.4% During the Induction Phase of Treatment With Topical Cyclosporine for Chronic Dry Eye Patients
Florida Eye Microsurgical Institute1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2007年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Ocular comfort
研究概览
简要总结
To compare bromfenac 0.09% and ketorolac 0.4% when used concomitantly with cyclosporine ophthalmic emulsion 0.05% in improving patient comfort during the induction phase of treatment for chronic dry eye disease
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
- •Must be in general good health
- •Diagnosis of moderate to severe dry eye syndrome
排除标准
- •Patients who are unlikely to respond to cyclosporine ophthalmic emulsion therapy
- •Patients who are pregnant or nursing females
- •Unwilling to discontinue use of contact lenses during the run-in and duration of the study
- •Presence or history of any systemic or ocular disorder or condition that could possibly interfere with the interpretation of the study results in the study eye
- •Previous treatment failure on CSA 0.05% (Restasis)
- •Known hypersensitivity to any component of the study or procedural medications
- •Participation in any other clinical trial within 30 days prior to screening
- •Known contraindication to any study medication or any of their components.
- •Should not be taking any oral anti-histamines, beta blockers or diuretics.
研究组 & 干预措施
1
Active Comparator
Active treatment arm bromfenac 0.09% BID for 6 weeks
干预措施: bromfenac (Drug)
2
Active Comparator
ketorolac 0.4% BID for 6 weeks
干预措施: ketorolac (Drug)
结局指标
主要结局
Ocular comfort
时间窗: six weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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