Evaluation of Dexamethasone Phosphate Delivered by Ocular Iontophoresis for Treatment of Dry Eye in the Controlled Adverse Environment Model
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Symptom: Ocular discomfort during CAE exposure at Visit 5
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of iontophoretic delivery of dexamethasone phosphate ophthalmic solution using the EyeGate® II Drug Delivery System in patients with dry eye.
详细描述
The objective of this study is to assess the safety and efficacy of Ocular Iontophoresis with Dexamethasone Phosphate 40 mg/mL 7.5 mA-min at 2.5 mA and Ocular Iontophoresis with Dexamethasone Phosphate 40 mg/mL 10.5 mA-min at 3.5 mA compared to placebo for the treatment of the signs and symptoms of dry eye.
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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a reported history of dry eye in each eye
- •Be at least 12 years of age
- •Demonstrate a response when exposed to the Controlled Adverse Environment model
排除标准
- •Have contraindications to the use of the test articles
- •Have known allergy or sensitivity to the study medication or their components (including corticosteroids)
- •Have any ocular infections, active ocular inflammation or preauricular lymphadenopathy
- •Be current contact lens wearers or wear contacts during the study
研究组 & 干预措施
Low Dose: DP 7.5 mA-min at 2.5 mA
Ocular Iontophoresis with EGP-437 (dexamethasone phosphate ophthalmic solution 40 mg/mL) 7.5 mA-min at 2.5 mA
干预措施: EGP-437 with EyeGate® II System (Drug)
High Dose: DP 10.5 mA-min at 3.5 mA
Ocular Iontophoresis with EGP-437 (dexamethasone phosphate ophthalmic solution 40 mg/mL) 10.5 mA-min at 3.5 mA
干预措施: EGP-437 with EyeGate® II System (Drug)
Placebo: 10.5 mA-min at 3.5 mA
Ocular Iontophoresis with Placebo (sodium citrate buffer solution 100 mM at 10.5 mA-min at 3.5 mA)
干预措施: Sodium citrate buffer solution with EyeGate® II System (Drug)
结局指标
主要结局
Symptom: Ocular discomfort during CAE exposure at Visit 5
时间窗: Visit 5 (Day 7 ± 2 Days)
Symptom: Ocular discomfort during CAE exposure at Visit 5 as measured by ORA scale.
Sign: Corneal fluorescein staining after CAE exposure at Visit 5
时间窗: Visit 5 (Day 7 ± 2 Days)
Corneal fluorescein staining after CAE exposure at Visit 5 as measured by the ORA scale.
次要结局
- Symptom: Ocular discomfort pre and post CAE(Visit 1 (Day -7 ± 2 Days), Visit 3 (Day 0), and Visit 5 (Day 7 ± 2 Days))
- Sign: Fluorescein staining at each visit over 3 weeks(7 visits / 3 weeks)