NCT00333268已完成3 期
Clinical Evaluation of the Safety and Efficacy of Next Generation Ophthalmic Irrigating Solution Compared to BSS Plus for Use During Cataract Extraction and IOL Implantation
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
- 369
- 试验地点
- 1
- 主要终点
- Percent change in endothelial cell density
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of Next Generation Ophthalmic Irrigating Solution (NGOIS) compared to BSS Plus for use during cataract extraction and intra-ocular lens (IOL) implantation.
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
- Double (Participant, Investigator)
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
- •Patients any race or sex 18 or older and undergoing cataract extraction with planned implantation of a posterior chamber intraocular lens.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
NGOIS
Experimental
干预措施: Next Generation Ophthalmic Irrigating Solution (NGOIS) (Drug)
BSS Plus
Active Comparator
干预措施: BSS Plus (Drug)
结局指标
主要结局
Percent change in endothelial cell density
次要结局
- Best corrected logMAR visual acuity
研究者
研究点 (1)
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