Pharmacokinetic Evaluation of Moxifloxacin in Vigadexa® in Aqueous Humor Samples Following Preoperative Antibiotic/Steroid Dosing in Cataract Surgery Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 36
- 主要终点
- Mean Aqueous Humor Concentration of Moxifloxacin
研究概览
简要总结
The purpose of this study was to determine the moxifloxacin aqueous penetration when dosing with a combination drug Vigadexa preoperatively in cataract patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Requires cataract surgery;
- •Acceptable health status (medical history, physical, laboratory and ophthalmologic exams);
- •Able to follow instructions and willing to attend all study visits;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Any known or suspected allergies/hypersensitivity to any of the investigational test product components;
- •History of invasive intraocular surgery in the eye to be operated, within 4 months before enrollment;
- •Use of medications, as specified in protocol;
- •Severe dry eye syndrome;
- •Use of contact lenses two days before surgery until the last visit;
- •External eye disease, infection or inflammation of the eyes or eyelids;
- •Excessive bleeding tendency;
- •No vision in the eye not included in the study;
- •Pregnant or breastfeeding;
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
VIGADEXA
Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution, 1 drop instilled in the study eye 2 days before surgery, followed by 1 drop instilled 4 times a day the day before surgery. On the day of surgery, 1 drop was instilled 60 minutes prior to the procedure.
干预措施: Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution (Drug)
结局指标
主要结局
Mean Aqueous Humor Concentration of Moxifloxacin
时间窗: Day 3 (operative day)
A 0.150 milliliter sample of the aqueous humor was obtained during cataract surgery. The concentration of moxifloxacin was measured by a validated procedure using high performance liquid-spectrometry.
次要结局
未报告次要终点