NCT03687931已完成1 期
A Phase 1/2 Dose-Ranging, Open-Label, Randomized, Clinical Study to Assess the Efficacy and Safety of Dexamethasone Ophthalmic Suspension Eye Drops for the Treatment of Inflammation Associated With Cataract Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 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
- Anterior Chamber Cell
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 two dose levels of dexamethasone ophthalmic suspension eye drops to determine if the drops decrease inflammation inside the eye and are safe after cataract surgery.
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
- None
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
- •Male or female patients at least 40 years of age scheduled for unilateral cataract surgery by phacoemulsification with posterior chamber intraocular lens implantation.
排除标准
- •Patients who have received a periocular corticosteroid injection in the study eye in the 3 months prior to screening.
- •Patients who anticipate requiring treatment with any corticosteroids by any route, except inhalation, during the study.
- •Patients who are known steroid responders
研究组 & 干预措施
Arm 1
Experimental
Dexamethasone suspension dose level 1
干预措施: Dexamethasone (Drug)
Arm 2
Experimental
Dexamethasone suspension dose level 2
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Anterior Chamber Cell
时间窗: 30 days
Number of cells in the anterior chamber
次要结局
未报告次要终点
研究者
研究点 (1)
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