NCT00332293已完成3 期
An Evaluation of the Safety and Efficacy of Moxifloxacin AF Ophthalmic Solution 0.5% for the Treatment of Bacterial Conjunctivitis in India
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 695
- 试验地点
- 1
- 主要终点
- Clinical cure and microbiological success
研究概览
简要总结
The purpose of the study is to determine whether AL-15469A is safe and effective in the treatment of bacterial conjunctivitis.
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
- 1 Month 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signs and symptoms of bacterial conjunctivitis
- •Other protocol-defined inclusion criteria may apply
排除标准
- •under 1 mo. age
- •Other protocol-defined exclusion criteria may apply
研究组 & 干预措施
Moxifloxacin
Experimental
干预措施: Moxifloxacin Alternative Formulation Ophthalmic Solution 0.5% (Drug)
VIGAMOX
Active Comparator
干预措施: Moxifloxacin hydrochloride ophthalmic solution 0.5% as base (Drug)
结局指标
主要结局
Clinical cure and microbiological success
次要结局
- Individual signs and symptoms of bacterial conjunctivitis at each visit
研究者
研究点 (1)
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