NCT00666042已完成不适用
Laboratory-masked, Randomized Parallel, Comparative, Pilot Study on the Bioavailability of Vigamox in the Aqueous Humor When Administered Either as Commercially Available Eye Drops or in a Spray Form
Advanced Ophthalmic Pharma1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2009年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Bioequivalency between the 2 ways of administration
研究概览
简要总结
The study compares the amounts of Vigamox absorbed when administered as eye drops or in a spray form. Both administrations will be prior to patients undergoing elective cataract surgery and the aqueous samples will be analyzed by a laboratory in a masked fashion. The hypothesis is that there will be no difference between the 2 modes of administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective cataract surgery
排除标准
- •Allergy to Vigamox
研究组 & 干预措施
A
Experimental
Vigamox delivered as spray
干预措施: Vigamox - administration in spray form (Drug)
B
Active Comparator
Patients will receive the commercially available Vigamox drops
干预措施: Vigamox eye drops (Drug)
结局指标
主要结局
Bioequivalency between the 2 ways of administration
时间窗: 4 months
次要结局
未报告次要终点
研究者
研究点 (1)
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