A Comparison of Peak Aqueous Penetration of Acuvail, Xibrom, and Nevanac in Patients Undergoing Phacoemulsification
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Peak Aqueous Penetration
研究概览
简要总结
Approximately 126 subjects scheduled to undergo cataract surgery by phacoemulsification, will be randomized in an even allocation (1:1:1) to either Acuvail, Xibrom, or Nevanac. Subjects will be instructed to begin dosing the study medication in the operative eye the day before surgery and continue dosing on the day of surgery. Beginning one hour before surgery, 1 drop of study medication will be instilled by operating room staff approximately every 15 minutes for a total of 3 doses. At the designated time a paracentesis will be performed at the start of the cataract procedure and at least 0.15 cc of aqueous humor will be collected. The sample will be immediately stored on dry ice and shipped to a laboratory for analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Subjects must be 18 years of age or older.
- •Scheduled for cataract surgery by phacoemulsification.
- •Subject must be willing to comply with all study requirements and be willing to give informed consent.
排除标准
- •Any subject that has a history of uveitis or active iritis.
- •Subject can have no previous eye surgery, with the exception of refractive surgery, but not within 6 months.
- •No ocular use of prostaglandins within 2 weeks of surgery.
- •Use of oral, injectable or topical ophthalmic steroids, nonsteroidal anti-inflammatory (NSAIDS) or immunosuppressants within 14 days prior to surgery.
- •Contraindications to NSAIDS.
- •Active ocular infection.
研究组 & 干预措施
Acuvail
Acuvail to be given preoperatively. One drop 2 times daily (BID), 1 day pre op and day of surgery 3 doses prior to surgery
干预措施: Ketorolac Tromethamine 0.45% (Drug)
Xibrom
Xibrom to be given 1 drop 2 times daily (BID) the day before surgery and 3 doses the day of surgery prior to surgery
干预措施: bromfenac 0.09% (Drug)
Nevanac
One day before surgery 1 drop 2 times daily (BID), then 3 doses the day of surgery
干预措施: nepafenac 0.1% (Drug)
结局指标
主要结局
Peak Aqueous Penetration
时间窗: day 4 of treatment
次要结局
未报告次要终点
研究者
Frank A. Bucci, Jr., M.D.
Medical Director
Bucci Laser Vision Institute