NCT00347932已完成3 期
A Study to Evaluate the Clinical and Microbial Efficacy of 0.6% ISV-403 Compared to Vehicle 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
- 957
- 主要终点
- Clinical Resolution of Baseline Bacterial Conjunctivitis
研究概览
简要总结
Evaluation of the clinical and microbial efficacy of 0.6% ISV-403, compared to vehicle in the 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
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have a diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in at least one eye.
- •Females of childbearing potential must utilized reliable contraceptive methods and have a negative pregnancy test.
排除标准
- •Pregnant or nursing females.
- •Known hypersensitivity to fluoroquinolones or to any of the study ingredients.
- •Use of any antibiotic within 72 hours of treatment.
- •Any disease or condition that could interfere with the safety and efficacy evaluations of the study medications.
- •Participation in an ophthalmic drug or device research study within 30 days prior to entry into the study.
研究组 & 干预措施
ISV-403
Experimental
0.6% ISV-403 ophthalmic suspension
干预措施: ISV-403 (Drug)
Vehicle
Placebo Comparator
Vehicle of ISV-403 ophthalmic suspension
干预措施: Vehicle (Drug)
结局指标
主要结局
Clinical Resolution of Baseline Bacterial Conjunctivitis
时间窗: Day 5 +/- 1 day
The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection
Microbial Eradication of Baseline Bacterial Infection
时间窗: Day 5 +/- 1 day
Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline.
次要结局
- Clinical Resolution of Baseline Bacterial Conjunctivitis(Day 8 or 9)
- Microbial Eradication of Baseline Bacterial Infection(Day 8 or 9)
研究者
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