A Prospective, Multi-Center, Randomized, Double-Masked, Safety, Tolerability and Efficacy Study of Four Iontophoretic Doses of Dexamethasone Phosphate Ophthalmic Solution in Patients With Non-Infectious Anterior Segment Uveitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 19
- 主要终点
- Proportion of subjects with an ACC score of zero at Days 14 and 28
研究概览
简要总结
The purpose of this study is to define a safe and effective dose of iontophoretic delivery of dexamethasone phosphate ophthalmic solution using the EyeGate® II Drug Delivery System in patients with non-infectious anterior segment uveitis.
详细描述
This is a randomized, double-masked, parallel group, dose-comparison, exploratory study of four doses of iontophoretic delivery of dexamethasone phosphate ophthalmic solution in patients with non-infectious anterior segment uveitis. The current study will evaluate the safety, tolerability, and efficacy of this technology at the four dose levels to determine a safe effective dose appropriate for future trials.
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
- •Non-infectious anterior uveitis
排除标准
- •Uveitis of infectious etiology
- •Previous anterior uveitis episode ≤ 4 weeks prior to baseline
- •Intraocular pressure (IOP) ≥ 25 mmHg at baseline, a history of glaucoma, and/or patients who require ocular anti-hypertensive medications
- •Topical corticosteroid treatment in either eye < 48 hours prior to baseline
- •Oral corticosteroid or intraorbital corticosteroid treatment in either eye < 2 weeks prior to baseline
- •Active intermediate or posterior uveitis
研究组 & 干预措施
EGP-437 1.6 mA-min at 0.4 mA
Ocular iontophoresis with EGP 437 1.6 mA-min at 0.4 mA
干预措施: EGP-437 1.6 mA-min at 0.4 with EyeGate® II System (Drug)
EGP-437 4.8 mA-min at 1.2 mA
Ocular iontophoresis with EGP-437 4.8 mA-min at 1.2 mA
干预措施: EGP-437 4.8 mA-min at 1.2 mA with EyeGate® II System (Drug)
EGP-437 10.0 mA-min at 2.5 mA
Ocular iontophoresis with EGP-437 10.0 mA-min at 2.5 mA
干预措施: EGP-437 10.0 mA-min at 2.5 mA with EyeGate® II System (Drug)
EGP-437 14.0 mA-min at 3.5 mA
Ocular iontophoresis with EGP-437 14.0 mA-min at 3.5 mA
干预措施: EGP-437 14.0 mA-min at 3.5 mA with EyeGate® II System (Drug)
结局指标
主要结局
Proportion of subjects with an ACC score of zero at Days 14 and 28
时间窗: Prospective study, subjects followed for 28 days
Proportion of subjects with an anterior chamber cell (ACC) score of zero at Days 14 and 28
次要结局
- Proportion of subjects with a reduction of one full ACC score or more from baseline at Day 28(Prospective study, subjects followed for 28 days)
- Change from baseline in ACC score at Day 28(Prospective study, subjects followed for 28 days)
- Treatment emergent adverse events(Prospective study, subjects followed for 28 days)
- Time to ACC score of zero(Prospective study, subjects followed for 28 days)