Safety and Efficacy of KPI-121 1% Ophthalmic Suspension Versus Prednisolone Acetate Ophthalmic Suspension 1% for the Treatment of Inflammation Following Cataract Surgery in Children 0 to 3 Years of Age
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 4
- 主要终点
- Anterior Chamber Cell Grade
研究概览
简要总结
This study is designed to assess how KPI-121 1% compares to prednisolone acetate in reducing inflammation after cataract surgery in young children. Approximately half the participants will receive KPI-121 1% eye drops and the other half will receive prednisolone acetate.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be a candidate for routine, uncomplicated cataract surgery
排除标准
- •Have a post-traumatic cataract.
- •Have suspected permanent low vision or blindness in the fellow non-study eye.
- •Have active uveitis in either eye.
- •Have an ocular neoplasm in either eye.
- •Have the presence of viral, bacterial, or fungal disease in either eye.
- •Have glaucoma, ocular hypertension, steroid-induced IOP (intraocular pressure) rise or elevated IOP
研究组 & 干预措施
KPI-121 1% BID (twice daily)
干预措施: KPI-121 1% (Drug)
Prednisolone acetate QID (four times daily)
干预措施: Prednisolone acetate (Drug)
结局指标
主要结局
Anterior Chamber Cell Grade
时间窗: Day 15
Anterior chamber cell grading is a way of quantifying the amount of inflammation in inflammatory eye processes. Higher values indicate greater inflammation. The anterior chamber cell grading uses whole numbers from 0 (no cells) to 4 (\> 30 cells) as follows: Anterior chamber cell grade 0 = no cells seen Anterior chamber cell grade 1 = 1 - 5 cells Anterior chamber cell grade 2 = 6 - 15 cells Anterior chamber cell grade 4 = greater than 30 cells
次要结局
- Modified Global Overall Assessment of Postoperative Inflammation(Day 15)