Parallel-group Study of Ocular Penetration of Peri-operative Topically Administered Fluoroquinolones With Cataract Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Aqueous Humor Concentration of Study Drug
研究概览
简要总结
This study is being conducted to evaluate the intraocular penetration of Moxifloxacin 0.5% ophthalmic solution (Vigamox) and Besifloxacin 0.6% ophthalmic suspension (Besivance) after pre-operative topical administration 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
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have a visually significant cataract and are planning to have cataract surgery.
- •Subjects who are willing/able and have signed informed consent approved by the Institutional Review Board.
排除标准
- •Subjects who have a known hypersensitivity, allergy, or contraindication to any fluoroquinolone medication, in any form.
- •Subjects who signs of ocular infection or active inflammation in the study eye.
- •Subjects who have corneal pathology, including epithelial defect, corneal scarring, or severe dry eye syndrome.
- •Subjects who have used any disallowed medication (including antibiotics) during the time period designated as described in the protocol.
- •Subjects who have any active or chronic/recurrent ocular or systemic disease that is uncontrolled and is likely to increase the risk of infection to the patient or confound the results of the study.
- •Subjects who are pregnant (or suspect to be pregnant) or nursing/lactating.
- •Subjects who have participated in any study of an investigational drug or device within 30 days prior to enrollment.
研究组 & 干预措施
Moxifloxacin 0.5% ophthalmic solution
干预措施: Moxifloxacin 0.5% ophthalmic solution (Drug)
Besifloxacin 0.6% ophthalmic suspension
干预措施: Besifloxacin 0.6% ophthalmic suspension (Drug)
结局指标
主要结局
Aqueous Humor Concentration of Study Drug
时间窗: approximately 3 to 4 months
Patients were randomly assigned to receive one drop of either moxifloxacin or besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30 minutes prior to the time of the cataract incision. The aqueous humor was corrected through the paracentesis site. The specimen was transferred immediately to a polypropylene tube and stored upright at ≤ 20° C. Moxifloxacin and besifloxacin concentrations in the aqueous humor were determined using a validated high performance liquid chromatography (HPLC)-tandem mass spectrometry method.
次要结局
- Disk Diffusion Assay of Collected Aqueous Humor(Approximately 3-4 months.)