NCT00705159已完成4 期
Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 1
- 主要终点
- Change From Baseline in the Total Blepharoconjunctivitis Grade.
研究概览
简要总结
The objective of this study is to evaluate the safety and effectiveness of Zylet in comparison with Lotemax, Tobramycin and the vehicle of Zylet for the treatment of blepharoconjunctivitis in pediatric subjects.
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
- 1 Week 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children 0-6 years of age.
- •clinical diagnosis of blepharoconjunctivitis
- •Parent/guardian must understand, be willing and able to comply with all treatment and follow-up procedures.
- •Parent/guardian must understand, be willing and able to provide informed consent and Health Insurance Portability Accountability Act (HIPAA) authorization.
排除标准
- •Known hypersensitivity to corticosteroids, aminoglycosides, or any component of the study medication.
- •Subjects who have a history of ocular surgery, including laser procedures, within the past 6 months.
- •Subjects who are monocular.
- •Subjects who have a history of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study.
- •Subjects who have participated in an ophthalmic drug or device research study within 30 days prior to entry in this study.
研究组 & 干预措施
Loteprednol etabonate and tobramycin
Experimental
Drug: Zylet (loteprednol etabonate and tobramycin)
干预措施: loteprednol etabonate and tobramycin (Drug)
Loteprednol etabonate
Active Comparator
Drug: Lotemax (loteprednol etabonate)
干预措施: loteprednol etabonate (Drug)
Tobramycin
Active Comparator
Drug: Tobramycin
干预措施: Tobramycin (Drug)
Vehicle
Placebo Comparator
Vehicle of Zylet
干预措施: Vehicle of Zylet (Drug)
结局指标
主要结局
Change From Baseline in the Total Blepharoconjunctivitis Grade.
时间窗: Baseline to 15 days
Change from baseline to visit 4 in the total blepharoconjunctivitis grade. Graded on a scale of 0-4, 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32.
次要结局
- Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 2(Baseline to Day 3)
- Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 3(Baseline to Day 7)
研究者
研究点 (1)
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