NCT01155999已完成3 期
Clinical Efficacy and Safety of T1225 Versus Tobramycin 0.3 % Eye Drops in the Treatment of Purulent Bacterial Conjunctivitis of Children.
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
- 286
- 主要终点
- The Primary Efficacy Variable Was Clinical Cure in the Worse Eye on Day 3
研究概览
简要总结
Efficacy/Safety of T1225, in comparison to reference product, for the treatment of purulent bacterial conjunctivitis of children.
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
- Single (Investigator)
入排标准
- 年龄范围
- 1 Day 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ one day of life and ≤ 18 years
- •Purulent bacterial conjunctivitis
排除标准
- 未提供
研究组 & 干预措施
T1225
Experimental
干预措施: T1225 (Drug)
Tobramycin
Active Comparator
干预措施: Tobramycin (Drug)
结局指标
主要结局
The Primary Efficacy Variable Was Clinical Cure in the Worse Eye on Day 3
时间窗: Day 3
Clinical cure was defined as a score 0 for bulbar conjunctival injection (evaluated using a 4 point ordinal scale) and a score 0 for conjunctival purulent discharge (evaluated using a 4 point ordinal scale).
次要结局
未报告次要终点
研究者
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