NCT00509873已完成3 期
A Study of the Safety and Efficacy of Gatifloxacin in Patients With 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
- 发起方
- Allergan
- 入组人数
- 578
- 主要终点
- Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge at Day 6
研究概览
简要总结
The study will determine the safety and efficacy of gatifloxacin eye drops in patients with 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Clinically diagnosed with bacterial conjunctivitis
排除标准
- •Signs and/or symptoms of conjunctivitis for more than 96 hours
- •Signs and/or symptoms suggestive of fungal, viral, or allergic conjunctivitis
- •Clinical diagnosis of chlamydia in either eye
研究组 & 干预措施
Gatifloxacin 0.5% Eye Drops
Experimental
Gatifloxacin 0.5% Eye Drops
干预措施: Gatifloxacin 0.5% eye drops (Drug)
Placebo Eye Drops
Placebo Comparator
Placebo Eye Drops
干预措施: placebo eye drops (Drug)
结局指标
主要结局
Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge at Day 6
时间窗: Day 6
Percentage of patients that achieved clinical success, defined as achievement of a score of zero for both conjunctival hyperemia and conjunctival discharge in the study eye at Day 6. Conjunctival hyperemia and conjunctival discharge were each assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe).
次要结局
- Percentage of Patients With Microbiological Cure at Day 6(Day 6)
- Percentage of Patients With Clinical Improvement of Ocular Signs at Day 6(Day 6)
- Percentage of Patients With Clinical Improvement of Ocular Symptoms at Day 6(Day 6)
研究者
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