NCT00198484已完成3 期
Evaluation of Vitrase (Hyaluronidase for Injection) Ovine, 200 USP Units/mL, as an Adjuvant to Increase the Absorption and Dispersion of Other Injected Drugs Prior to Ocular Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 18
- 主要终点
- Physician Satisfaction Survey
研究概览
简要总结
The purpose of this study is to determine whether Vitrase (hyaluronidase for injection) is effective as a spreading agent for other injected drugs prior to ocular surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Scheduled for an ophthalmic surgical procedure
排除标准
- •Documented history of hypersensitivity to hyaluronidase or any other ingredient in Vitrase
- •Known history of hypersensitivity reaction to bee or wasp venom
- •Needing enhanced absorption and dispersion of dopamine, alpha agonist drugs, furosemide, the benzodiazepines, or phenytoin
- •Inflammation or apparent clinical signs of infection in the area where Vitrase was to be injected
研究组 & 干预措施
Vitrase
Experimental
ovine hyaluronidase injection 150 USP Units in 1 mL solution. Single dose of Vitrase will be administered as an adjuvant prior to ophthalmologic surgery
干预措施: Vitrase (Drug)
结局指标
主要结局
Physician Satisfaction Survey
时间窗: 1-2 days
Physician evaluation of effectiveness of Vitrase as an adjuvant and overall satisfaction, via questionnaire;
次要结局
- Adverse Events(1-2 days)
研究者
研究点 (18)
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