NCT00972777已完成2 期
A Study to Evaluate the Clinical and Microbial Efficacy of Besifloxacin Ophthalmic Suspension, 0.6% BID Compared to Vehicle in the Treatment of Bacterial Conjunctivitis.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 474
- 试验地点
- 1
- 主要终点
- Clinical Resolution
研究概览
简要总结
This study is being conducted to evaluate the clinical and microbial efficacy of besifloxacin ophthalmic suspension compared with vehicle in the treatment of bacterial conjunctivitis. This study was conducted as a phase IIb study and continued with further enrollment as a phase III study.
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 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who are at least one year of age.
- •Subjects who have a clinical diagnosis of acute bacterial conjunctivitis.
- •Subjects who are willing to discontinue contact lens wear for the duration of the study.
排除标准
- •Subjects who have any uncontrolled systemic disease or debilitating disease.
- •Subjects with known sensitivity or contraindications to besifloxacin, fluoroquinolones or any ingredients in study drugs.
- •Subjects who are expected to require treatment with any disallowed medications.
研究组 & 干预措施
Besifloxacin
Experimental
0.6% ophthalmic suspension
干预措施: Besifloxacin (Drug)
Vehicle
Placebo Comparator
干预措施: Vehicle (Placebo) (Drug)
结局指标
主要结局
Clinical Resolution
时间窗: Visit 2
The absence of both conjunctival discharge and bulbar conjunctival injection.
Microbial Eradication
时间窗: Visit 2
The absence of ocular bacteria that were present at or above pathogenic threshold levels at baseline.
次要结局
- Clinical Resolution(Visit 3)
- Microbial Eradication(Visit 3)
研究者
研究点 (1)
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