NCT00656539已完成4 期
A Single-Center, Open-Label, Randomized Pilot Study of the Safety and Efficacy of AzaSite® Ophthalmic Solution, 1% in Combination With Mechanical Therapy Versus Mechanical Therapy Alone for Four Weeks in Subjects With Posterior Blepharitis
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
- 20
- 试验地点
- 1
- 主要终点
- Change in clinical signs and symptoms associated with blepharitis
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of AzaSite® ophthalmic solution, 1% on signs and symptoms of blepharitis.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of moderate to severe chronic posterior blepharitis
- •If female of childbearing potential, are non-pregnant and non-lactating
排除标准
- •had ocular surface surgery (LASIK, refractive, pterygium) within the past year
- •unwilling to discontinue use of contact lenses during the study
- •have glaucoma
- •unable or unwilling to withhold the use of eyelid scrubs during the study
- •have a serious systemic disease or uncontrolled medical condition that in the judgment of the investigator could confound study assessments or limit compliance
- •currently using any preserved topical ocular medications (with the exception of unpreserved tear substitutes) at the time of entry into the study or during study participation
研究组 & 干预措施
1
Experimental
AzaSite®
干预措施: AzaSite® (Drug)
结局指标
主要结局
Change in clinical signs and symptoms associated with blepharitis
时间窗: 4 weeks
次要结局
- Standard ocular safety assessments(4 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Safety and Efficacy Pilot Study of AzaSite (Azithromycin) in Subjects With BlepharitisBlepharitisNCT00629590Merck Sharp & Dohme LLC20
已完成
4 期
Safety and Efficacy Pilot Study of AzaSite® (Azithromycin) in Subjects With BlepharitisBlepharitisNCT00629980Merck Sharp & Dohme LLC60
已完成
4 期
Safety and Efficacy Study of AzaSite® in Subjects With BlepharitisBlepharitisNCT00629941Merck Sharp & Dohme LLC25
撤回
2 期
Study to Determine the Effect of Azasite on Corneal Surface IrregularityMeibomian Gland DysfunctionNCT01797107Philadelphia Eye Associates
已完成
3 期
Comparative Study of AzaSite Plus Compared to AzaSite Alone and Dexamethasone Alone to Treat Subjects With BlepharoconjunctivitisBlepharoconjunctivitisNCT00578955Sun Pharmaceutical Industries Limited417