NCT00346528已完成3 期
Safety of NGOIS Compared to BSS Plus in Pediatric Patients
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
- 18
- 试验地点
- 1
- 主要终点
- Safety Variables: Endothelial cell density, visual acuity, intraocular pressure, ocular signs and fundus assessment
研究概览
简要总结
To evaluate the Safety of Next Generation Ophthalmic Irrigating Solution compared to BSS Plus for use during cataract surgery in Pediatric patients.
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
- 1 Week 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cataract present.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •As per age requirements.
- •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
Safety Variables: Endothelial cell density, visual acuity, intraocular pressure, ocular signs and fundus assessment
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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