TOBRADEX Ophthalmic Suspension Versus Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 221
- 试验地点
- 1
- 主要终点
- Percent of Patients Who Display Microbiological Success (Eradication of Baseline Pathogens at Day 4)
研究概览
简要总结
The purpose of this study is to describe the differences in efficacy between TOBRADEX Ophthalmic Suspension and Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension in the treatment of ocular inflammation and infection associated with blepharaconjunctivitis
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
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ocular inflammation associated with blepharaconjunctivitis
排除标准
- •ocular allergy
- •ocular disorders that would preclude safe administration of test article
研究组 & 干预措施
Tobramycin 0.3%/Dexamethasone 0.05%
Tobramycin 0.3%/Dexamethasone 0.05% 1 drop 4 times daily in both eyes
干预措施: Tobramycin 0.3%/Dexamethasone 0.05% (Drug)
TOBRADEX
TOBRADEX 1 drop 4 times daily in both eyes
干预措施: TOBRADEX (Drug)
结局指标
主要结局
Percent of Patients Who Display Microbiological Success (Eradication of Baseline Pathogens at Day 4)
时间窗: Day 4 - Test Of Cure (TOC) compared to Day 0
Microbiological success was declared if the pre-therapy pathogens were eradicated at the Exit Visit; conversely, microbiological failure was declared if pre-therapy pathogens persisted at the exit visit. The microbiological outcomes were calculated based on an algorithm that assessed whether pre-therapy pathogens were eradicated or persisted as demonstrated by comparative characterization of recovered bacteria.
次要结局
未报告次要终点