NCT00575367已完成4 期
A Single-Center, Open-Label, Randomized Study of the Pharmacokinetics of AzaSite Ophthalmic Solution Versus Vigamox in the Tears of Healthy Volunteers Following a Single Ocular Administration
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
- 37
- 试验地点
- 1
- 主要终点
- Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration.
研究概览
简要总结
The purpose of this study is to evaluate the drug concentrations of AzaSite compared to Vigamox in tears of healthy volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •Have visual acuity, using corrective lenses (no contact lenses) if necessary, in both eyes of at least +0.7 as assessed by Early Treatment of Diabetic Retinopathy Study.
- •Have normal lid anatomy.
排除标准
- •Have an abnormal biomicroscopy or ophthalmoscopy exam.
- •Have a diagnosis of dry eye disease or have experienced any of the dry eye symptoms (photophobia, foreign body sensation, itching, burning, pain, dry or grittiness) in the past thirty days.
- •Have used artificial tears in the past thirty days.
- •Have a diagnosis of on-going ocular infection or lid margin inflammation.
- •Have ever had penetrating ocular surface or intraocular surgery.
- •Have a known hypersensitivity to azithromycin, or any macrolide antibiotic or to any of the ingredients in AzaSite.
- •Have had a known hypersensitivity to Vigamox or any fluoroquinolone antibiotics or to any of the ingredients in Vigamox.
- •Have had corneal or lid abnormalities.
- •Have glaucoma, or Intra Ocular Pressure of 22 mm Hg or greater in one or both eyes.
- •Have any ocular pathology with the exception of cataracts.
- •Have a serious systemic disease or uncontrolled medical condition.
- •Have experienced symptoms of viral or allergic conjunctivitis in the past 30 days.
- •Have a history of liver or kidney disease resulting in persisting dysfunction.
研究组 & 干预措施
AzaSite
Active Comparator
干预措施: AzaSite (azithromycin ophthalmic solution) (Drug)
Vigamox
Active Comparator
干预措施: Vigamox (moxifloxacin hydrochloride ophthalmic solution) (Drug)
结局指标
主要结局
Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration.
时间窗: 15 minutes, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours
次要结局
未报告次要终点
研究者
研究点 (1)
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