NCT00105469已完成3 期
A Study to Evaluate the Clinical and Microbial Efficacy and Safety of 1.0% AzaSite Compared to 0.3% Tobramycin Ophthalmic Solution in the Treatment of 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
- 入组人数
- 743
- 试验地点
- 25
- 主要终点
- Number of Participants Who Achieved Clinical Resolution at Visit 3
研究概览
简要总结
The purpose of this study is to evaluate the clinical and microbial efficacy and safety of AzaSite compared to tobramycin for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye are eligible. Subjects will be randomly assigned to the AzaSite group or Tobramycin group. Three visits will be required for the 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
- Triple (Participant, 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
- •Male or female subject, of any race, who is at least 1 year of age.
- •Subjects must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit mucopurulent or purulent conjunctival discharge (crusty or sticky eyelids, globular and yellow discharge) and redness in at least one eye.
- •The symptoms of bacterial conjunctivitis must be present for 3 days (approximately 72 hours) or less.
- •Must be willing to discontinue contact lens wear for the duration of the study.
排除标准
- •Any uncontrolled systemic disease or debilitating disease.
- •Use of topical ophthalmic solutions including tear substitutes within 2 hours before and during the study.
- •Use of any topical ophthalmic anti-inflammatory agents within 48 hours before and during study.
- •Any active upper respiratory tract infection.
- •Pregnant or nursing females.
- •Use of any antibiotic (topical or systemic) within 72 hours of enrollment.
研究组 & 干预措施
AzaSite
Experimental
1.0% azithromycin in DuraSite
干预措施: AzaSite (Drug)
Tobramycin
Active Comparator
0.3% tobramycin
干预措施: Tobramycin (Drug)
结局指标
主要结局
Number of Participants Who Achieved Clinical Resolution at Visit 3
时间窗: Visit 3 (Day 6)
Clinical resolution is defined as absence of all three clinical signs (ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection).
次要结局
- Number of Participants Who Achieved Bacterial Eradication at Visit 3(Visit 3 (Day 6))
研究者
研究点 (25)
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