NCT01330355终止3 期
Evaluation of the Safety and Efficacy of Topical Besifloxacin Ophthalmic Suspension, 0.6% Compared With Gatifloxacin, 0.3% Ophthalmic Solution for the Treatment of Presumed Bacterial Conjunctivitis in Subjects From Birth to 31 Days of Age
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Clinical Resolution
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of Besivance (besifloxacin 0.6%) ophthalmic suspension compared to gatifloxacin 0.3% ophthalmic solution when administered three times daily (TID) for seven days to neonatal subjects who are 31 days or younger on the day of randomization (Visit 1).
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 (Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Day 至 31 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have a clinical diagnosis of acute bacterial conjunctivitis and exhibit conjunctival discharge and redness in at least one eye. A minimum score of 1 should be present for discharge and a minimum score of 1 for conjunctival hyperemia in the same eye.
排除标准
- •Subjects with conjunctivitis signs and/or symptoms suggestive of fungal, protozoal, or viral etiology in either eye.
- •Subjects who require or are expected to require (other than study medication) use of any topical ocular medication in either eye, or systemic medications during the course of the study or prior to Day 1 specified in the protocol as ineligible.
- •Subjects with any abnormality of the ocular anatomy or ocular disease/disorder specified in the protocol as ineligible.
- •Subjects with systemic disease/disorder specified in the protocol as ineligible.
- •Subjects who have a known or suspected poor tolerance, sensitivity, or allergy to the study medications or any of their components.
- •Subjects who have a condition or are in a situation which in the investigator's opinion may impact their safety or would negatively affect the conduct or outcome of the study.
研究组 & 干预措施
Besivance
Experimental
Besifloxacin 0.6% ophthalmic suspension
干预措施: Besivance (Drug)
Gatifloxacin
Active Comparator
Gatifloxacin 0.3% ophthalmic solution
干预措施: Gatifloxacin (Drug)
结局指标
主要结局
Clinical Resolution
时间窗: Visit 5 (Day 8+1)
Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia.
次要结局
- Clinical Resolution(Visit 3 (Day 3))
- Microbial Eradication(Visit 5 (Day 8+1))
- Microbial Outcome(Visit 3 (Day 3) and Visit 5 (Day 8+1))
研究者
研究点 (1)
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