NCT01238783撤回2 期
Safety and Efficacy of AL-15469A 0.5% / AL-6515 0.3% Ophthalmic Suspension for 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
- 撤回
- 主要终点
- End of therapy Clinical Cure rate
研究概览
简要总结
To assess safety and efficacy of AL-15469A 0.5% /AL-6515 0.3% Ophthalmic Suspension for 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
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients of any race
- •5 years of age and older at the time of the Day 1 visit
- •with a primary clinical diagnosis of bacterial conjunctivitis.
排除标准
- •Onset of bacterial conjunctivitis (signs and symptoms) more than 4 days
- •Presence of punctal plug or punctal occlusion
- •Visual Acuity worse than 20/80
- •Upper respiratory infection
研究组 & 干预措施
AL-6515 0.3%
Experimental
干预措施: AL-6515 0.3% (Drug)
AL-15469A 0.5% and AL-65150.3% Ophthalmic Suspension
Experimental
干预措施: AL-15469A 0.5% and AL-6515 0.3% Ophthalmic Suspension (Drug)
AL-15469A 0.5%
Experimental
干预措施: AL-15469A 0.5% (Drug)
Vehicle
Placebo Comparator
干预措施: Vehicle (Drug)
结局指标
主要结局
End of therapy Clinical Cure rate
时间窗: Day 4
Sustained Clinical Cure rate
时间窗: Day 3
次要结局
- Sustained bulbar conjunctival injection(Day 3)
- Microbiological Success(Day 4)
研究者
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