NCT00824070已完成1 期
An Open-Label, Randomized Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects After a Single Topical Dose
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- The Aqueous Humor Drug Concentration.
研究概览
简要总结
This study is being conducted to assess the concentration of besifloxacin, moxifloxacin, or gatifloxacin in aqueous humor samples collected following topical instillation of the associated formulation in subjects undergoing 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
- Screening
- 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
- •Subjects who are a candidate for a routine, uncomplicated, primary cataract extraction.
- •Subjects who, in the Investigator's opinion, have potential for postoperative best corrected Snellen visual acuity of at least 20/200 in the study eye.
排除标准
- •Subjects who have a known sensitivity, contraindication, or allergy to the study medication(s) or their components.
- •Subjects who had any corneal refractive surgery in the study eye.
- •Subjects who have a history or presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result of the study.
- •Subjects who had ocular surgery in the study eye, including laser procedures, within the past 6 months.
- •Subjects who have taken any topical ocular medication in the study eye, other than those required by the protocol and permitted for surgery, during the 24 hours prior to the study medication being instilled.
- •Subjects who use any antibiotics (e.g., systemic or topical) within the 7 days prior to the surgery date.
- •Subjects who are monocular.
研究组 & 干预措施
Besifloxacin
Experimental
Besifloxacin ophthalmic suspension
干预措施: Besifloxacin hydrochloride (Drug)
Moxifloxacin
Active Comparator
Vigamox (moxifloxacin ophthalmic solution, 0.5%)
干预措施: moxifloxacin hydrochloride (Drug)
Gatifloxacin
Active Comparator
Zymar (gatifloxacin ophthalmic solution, 0.3%)
干预措施: gatifloxacin (Drug)
结局指标
主要结局
The Aqueous Humor Drug Concentration.
时间窗: Visit 2, 1-14 days following screening visit
An aqueous humor specimen was collected from the study eye for determination of drug concentration 60 min after study drug instillation.
次要结局
未报告次要终点
研究者
研究点 (1)
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