NCT00754949撤回3 期
A Randomized, Double-Masked, Parallel-Group, Comparative Study to Evaluate the Clinical and Anti-Microbial Efficacy and Safety of AzaSite Plus Compared to AzaSite Alone and Dexamethasone Alone in the Treatment of Subjects With Blepharoconjunctivitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Resolution of the clinical signs and symptoms.
研究概览
简要总结
The purpose of this study is to determine if AzaSite Plus is effective and safe for the treatment of blepharoconjunctivitis compared to AzaSite alone and Dexamethasone alone.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a clinical diagnosis of blepharoconjunctivitis
- •Must be willing to discontinue contact lens wear for the duration of the study
- •Have best corrected visual acuity of 6/24 in both eyes
- •Have IOP less than or equal to 25 mmHg in either eye
排除标准
- •Have known sensitivity or poor tolerance to any component of the study medications
- •Have a history of eyelid and/or ocular surgery and/or have had ocular surgical intervention within 6 months prior to visit 1 or during the study and/or a history of refractive surgery within 6 months
- •Have worn contact lenses 72 hours prior to visit 1 and/or need to wear contact lenses for the duration of the study
- •Have used any topical ophthalmic solutions including tear substitutes within 2 hours of enrollment
- •Use of any eye make-up during the study
- •Have any uncontrolled systemic disease or debilitating disease
- •Have been diagnosed with glaucoma
- •Have any clinically significant cardiovascular disorders
- •Have any history of liver or kidney disease resulting in persisting dysfunction
- •Have prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device
研究组 & 干预措施
1
Experimental
干预措施: 1% Azithromycin and 0.1% Dexamethasone (Drug)
2
Active Comparator
干预措施: 1% Azithromycin (Drug)
3
Active Comparator
干预措施: 0.1% Dexamethasone (Drug)
结局指标
主要结局
Resolution of the clinical signs and symptoms.
时间窗: 2 weeks
次要结局
- Bacterial eradication(2 weeks)
研究者
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