NCT04711213已完成2 期
A Phase 2 Clinical Study to Assess the Efficacy and Safety of SED80 for the Treatment of Inflammation and Pain Associated With Cataract Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- iDrop, Inc.
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Ocular inflammation
研究概览
简要总结
Patients at least 40 years of age who are undergoing cataract surgery will be randomized to receive treatment with one of four groups of dexamethasone ophthalmic suspension or placebo eye drops to determine if the drops decrease inflammation and pain inside the eye and are safe after cataract surgery.
详细描述
"Patients undergoing traditional cataract surgery routinely develop inflammation and pain. This study will evaluate 4 arms of either dexamethasone or placebo.
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 (Participant)
盲法说明
Single Masked randomized study
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing traditional cataract surgery.
排除标准
- •Patients with unusual ocular conditions.
研究组 & 干预措施
Placebo Dose 2
Placebo Comparator
干预措施: Placebo Dose 2 (Drug)
Dexamethasone Dose 1
Active Comparator
干预措施: Dexamethasone Dose 1 (Drug)
Dexamethasone Dose 2
Active Comparator
干预措施: Dexamethasone Dose 2 (Drug)
Placebo Dose 1
Placebo Comparator
干预措施: Placebo Dose 1 (Drug)
结局指标
主要结局
Ocular inflammation
时间窗: Day 8
Measuring Anterior Cell Count
次要结局
- Ocular Pain(Day 8)
研究者
研究点 (1)
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