NCT00464438已完成4 期
A Study to Evaluate the Safety and Efficacy of Gatifloxacin for the Treatment of Bacterial Conjunctivitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 171
- 主要终点
- Percentage of Patients With Clearing (Clinical Success) of Conjunctival Erythema and Conjunctival Discharge at Day 7
研究概览
简要总结
This is a 7 day study to evaluate the safety and efficacy of topical gatifloxacin ophthalmic solution for the treatment of bacterial conjunctivitis in subjects from birth to 31 days of age
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
- — 至 31 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with bacterial conjunctivitis
排除标准
- •chemical or foreign body trauma to either eye
- •infection in either eye (besides bacterial conjunctivitis)
- •white spots in the cornea or ulcers in either eye
- •clinical diagnosis of chlamydia or gonorrhea in either eye
研究组 & 干预措施
2
Active Comparator
干预措施: gatifloxacin (Drug)
2
Active Comparator
干预措施: moxifloxacin 0.5% eye drops (Drug)
1
Experimental
干预措施: gatifloxacin (Drug)
结局指标
主要结局
Percentage of Patients With Clearing (Clinical Success) of Conjunctival Erythema and Conjunctival Discharge at Day 7
时间窗: Day 7
Percentage of patients that achieved clinical success, defined as a score of 0 for both conjunctival erythema and conjunctival discharge at Day 7. Conjunctival erythema 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 Improvement(Day 7)
- Percentage of Patients With Improvement in Ocular Signs for Lid Erythema(Days 7)
- Percentage of Patients With Improvement in Ocular Signs for Conjunctival Discharge at Day 7(Day 7)
研究者
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