NCT00348348已完成3 期
A Study to Evaluate the Clinical and Microbial Efficacy of 0.6% ISV-403 Compared to Vigamox in the Treatment of Bacterial Conjunctivitis
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
- 1,161
- 主要终点
- Microbial Eradication
研究概览
简要总结
This is a study to investigate a novel drug candidate for 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in at least one eye.
排除标准
- •Pregnant or nursing females.
- •Use of any antibiotic within 72 hours of enrollment.
- •Any disease conditions that could interfere with the safety and efficacy evaluations of the study drug.
- •Participation in an ophthalmic drug or device research study within 30 days prior to entry into this study.
研究组 & 干预措施
Moxifloxacin solution
Active Comparator
Moxifloxacin hydrochloride ophthalmic solution 0.5%
干预措施: Moxifloxacin solution (Drug)
Besifloxacin Suspension
Experimental
Besifloxacin hydrochloride ophthalmic suspension 0.6%
干预措施: Besifloxacin (Drug)
结局指标
主要结局
Microbial Eradication
时间窗: Day 5 (+/- 1 day)
eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated
Clinical Resolution
时间窗: Day 5(+/- 1 day)
Resolution of conjunctival discharge and bulbar conjunctival injection. (mITT, culture confirmed, as treated)
次要结局
- Microbial Eradication(Day 8 or Day 9)
- Clinical Resolution(Day 8 or Day 9)
研究者
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