NCT00362895已完成3 期
A Double-Masked, Parallel-Group, Randomized, Single-Dose Bioequivalence Study of Tobradex AF Suspension and TOBRADEX Ophthalmic Suspension
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 995
- 试验地点
- 1
- 主要终点
- Concentration of dexamethasone in aqueous humor following a single topical ocular administration
研究概览
简要总结
The purpose of the study is to determine the amount of study medication that moves from the front of the eye into the fluid at the front of the inside of the 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
- •18 or older
- •Other protocol-defined inclusion criteria may apply
排除标准
- •Other protocol-defined exclusion criteria may apply
研究组 & 干预措施
Tobradex AF
Experimental
干预措施: Tobramycin 0.3% / Dexamethasone 0.033% ophthalmic suspension (Drug)
TOBRADEX
Active Comparator
干预措施: Tobramycin 0.3% / Dexamethasone 0.1% ophthalmic suspension (TOBRADEX) (Drug)
结局指标
主要结局
Concentration of dexamethasone in aqueous humor following a single topical ocular administration
次要结局
未报告次要终点
研究者
研究点 (1)
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