NCT00575380已完成4 期
A Multi-Center, Open-Label, Randomized Study of the Pharmacokinetics of Azithromycin Versus Moxifloxacin in Conjunctiva and Aqueous Humor Following Single or Multiple Ocular Administration of AzaSite Ophthalmic Solution, 1% or Vigamox in Subjects Undergoing Routine Cataract Surgery
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
- 116
- 试验地点
- 13
- 主要终点
- Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population)
研究概览
简要总结
The purpose of this study is to evaluate the drug concentrations in the conjunctiva and aqueous humor of AzaSite™ compared to Vigamox® in subjects undergoing routine cataract surgery
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are scheduled to undergo routine cataract surgery by the investigator's preferred technique.
- •Have normal appearing, freely mobile, conjunctiva in the inferior temporal portion cul-de-sac site of the operative eye.
排除标准
- •Have concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye.
- •Have a history of ocular pemphigoid.
- •Have ever had penetrating ocular surface surgery.
- •Have had intraocular surgery within the past 3 months.
- •Have ever had prior surgery or full penetrating trauma to the conjunctiva at the proposed surgical site.
- •Have a planned cataract surgery in the contraleteral eye within 2 weeks of the study related surgical procedure and sample collection.
- •Have a combined procedure planned (trabeculectomy surgery planned in the same eye as cataract extraction surgery).
- •Have at the proposed conjunctiva biopsy site, signs of conjunctival shortening of the fornix, scarring or adherence to the underlying episclera.
- •Have according to the investigator's judgment, risk of intra- or post-operative complications related to their cataract surgery as a consequence of participation in the study.
- •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.
- •Are unable or unwilling to withhold for a minimum of 3 weeks prior to initiation of study drug, the ocular or systemic use of either azithromycin or moxifloxacin, when it is the same medication as the subject's assigned study drug. This relates as well, to the use of either of these medications as a pre-surgical prophylaxis.
- •Are unable or unwilling to withhold for a minimum of 3 weeks prior to initiation of study drug, the use of erythromycin ointment or ofloxacin.
- •Have any ocular pathology with the exception of cataracts that in the judgment of the investigator could confound study assessments or limit compliance.
- •Have a serious systemic disease or uncontrolled medical condition or psychiatric condition that in the judgement of the investigator could confound study assessments or limit compliance.
研究组 & 干预措施
AzaSite Eye Drops
Active Comparator
One drop two times a day for two days and once a day for the next five days
干预措施: AzaSite Eye Drops (Drug)
Vigamox Eye Drops
Active Comparator
One drop three times a day for seven days
干预措施: Vigamox Eye Drops (Drug)
结局指标
主要结局
Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population)
时间窗: Az(hr): 1,12,48,49,72,144,145,168,216,312; Vig(hr): 1,8,48,49,56,144,145,168,216,312
Nominal time is scheduled time relative to administration of the first eye drop
次要结局
- Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population)(Az(hr): 1,12,48,49,72,144,145,168,216,312; Vig(hr): 1,8,48,49,56,144,145,168,216,312)
研究者
研究点 (13)
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