A Prospective, Multi-Center, Randomized, Double-Masked, Positive Controlled, Phase 3 Clinical Trial Designed to Evaluate the Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution Compared to Prednisolone Acetate Ophthalmic Suspension (1%) in Patients With Non-Infectious Anterior Segment Uveitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 251
- 试验地点
- 1
- 主要终点
- Proportion of subjects with an AC cell count of zero at Day 14
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate ophthalmic solution EGP-437 using the EyeGate® II Drug Delivery System (EGDS) compared to prednisolone acetate ophthalmic suspension (1%) in patients with non-infectious anterior segment uveitis.
详细描述
This will be a Phase 3, randomized, double-masked, parallel arm, positive-controlled non-inferiority study, in which up to 250 subjects (approximately 125 subjects per treatment arm) will be enrolled at up to 60 clinical sites. Patients with non-infectious anterior segment uveitis who are interested in participating in the study will be provided an informed consent form prior to screening. Screening/Baseline procedures which include BCVA, slit lamp examination, fundus exam, IOP by tonometry will be used to determine eligibility.
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
- 12 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12 to 85 years with a diagnosis of non-infectious anterior segment uveitis defined as an AC cell count of ≥ 11 cells
- •Receive, understand, and sign a copy of the written informed consent form
- •Be able to return for all study visits and willing to comply with all study-related instructions
排除标准
- 未提供
研究组 & 干预措施
Dexamethasone Phosphate Ophthalmic Solution
Dexamethasone phosphate ophthalmic solution (40 mg/mL)
干预措施: Dexamethasone Phosphate Ophthalmic Solution (Drug)
Prednisolone Acetate Ophthalmic (1%)
Prednisolone Acetate Ophthalmic (1%)
干预措施: Prednisolone Acetate Ophthalmic (1%) (Drug)
结局指标
主要结局
Proportion of subjects with an AC cell count of zero at Day 14
时间窗: Day 14 ± 2 days
次要结局
未报告次要终点