NCT00651586已完成2 期
Safety and Efficacy Study of Gatifloxacin Compared With Ciprofloxacin in Patients With Acute Bacterial Corneal Ulcers
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 129
- 主要终点
- Complete re-epithelialization of the corneal ulcer
研究概览
简要总结
This study evaluates the safety and efficacy of gatifloxacin 0.3% ophthalmic solution compared with ciprofloxacin 0.3% ophthalmic solution in patients with acute bacterial corneal ulcers
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
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis in one eye only of an acute bacterial corneal ulcer (>1mm)
排除标准
- •Corneal ulcer that in the opinion of the investigator had to be treated with fortified antibiotics, or multiple antibiotics, or anti-infectives other than study medication
研究组 & 干预措施
1
Experimental
Gatifloxacin 0.3% ophthalmic solution
干预措施: Gatifloxacin 0.3% ophthalmic solution (Drug)
2
Active Comparator
Ciprofloxacin 0.3% ophthalmic solution
干预措施: Ciprofloxacin 0.3% ophthalmic solution (Drug)
结局指标
主要结局
Complete re-epithelialization of the corneal ulcer
时间窗: Day 21
次要结局
- Microbiological Cure(Day 21)
- Patient reported outcomes(Day 21)
- Investigator's evaluation of clinical efficacy(Day 21)
研究者
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