Single Center, Single-masked, Randomized, Dose Escalation Study to Evaluate Safety and Tolerability of Transscleral Iontophoresis Using Citrate Buffer Delivered by the EyeGate® II Drug Delivery Device System in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Safety assessed through patient reported adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of a single iontophoretic dose of buffered solution administered through the EyeGate® II Drug Delivery System in healthy adult human volunteers.
详细描述
This is a single center, randomized, single-masked, comparative group, safety and tolerability study of single dose levels of citrate buffer delivered through transcleral iontophoresis administered via the EyeGate® II Drug Delivery System. The current study will also determine the safety and tolerability of the dose ranges of transcleral iontophoresis from 2 mA through 7 mA and will determine the safety and tolerability of the application of the Eyegate II system on the eye for time ranges of up to 10.5 minutes.
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)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults
- •Normal ophthalmic examination in both eyes
排除标准
- •Presence of subjective ocular symptoms
- •Presence of conjunctival hyperemia, chemosis, watering, conjunctival discharge
- •Ocular trauma
研究组 & 干预措施
1: 0 mA-min (0 mA for 4 min)
Ocular iontophoresis 0 mA-min (0 mA for 4 minutes)
干预措施: EyeGate II® Drug Delivery System (Other)
1: 0 mA-min (0 mA for 4 min)
Ocular iontophoresis 0 mA-min (0 mA for 4 minutes)
干预措施: Citrate buffer (Drug)
2: 4 mA-min (2 mA for 2 min), + polarity
Ocular iontophoresis 4 mA-min (2 mA for 2 minutes), positive polarity
干预措施: EyeGate II® Drug Delivery System (Other)
2: 4 mA-min (2 mA for 2 min), + polarity
Ocular iontophoresis 4 mA-min (2 mA for 2 minutes), positive polarity
干预措施: Citrate buffer (Drug)
6: 8 mA-min (4 mA for 2 min), + polarity
Ocular iontophoresis 8 mA-min (4 mA for 2 minutes), positive polarity
干预措施: Citrate buffer (Drug)
3: 5 mA-min (2.5 mA for 2 min), +
Ocular iontophoresis 5 mA-min (2.5 mA for 2 minutes), positive polarity
干预措施: EyeGate II® Drug Delivery System (Other)
3: 5 mA-min (2.5 mA for 2 min), +
Ocular iontophoresis 5 mA-min (2.5 mA for 2 minutes), positive polarity
干预措施: Citrate buffer (Drug)
4: 6 mA-min (3 mA for 2 min), + polarity
Ocular iontophoresis 6 mA-min (3 mA for 2 minutes), positive polarity
干预措施: EyeGate II® Drug Delivery System (Other)
4: 6 mA-min (3 mA for 2 min), + polarity
Ocular iontophoresis 6 mA-min (3 mA for 2 minutes), positive polarity
干预措施: Citrate buffer (Drug)
5: 7 mA-min (3.5 mA for 2 min), +
Ocular iontophoresis 7 mA-min (3.5 mA for 2 minutes), positive polarity
干预措施: EyeGate II® Drug Delivery System (Other)
5: 7 mA-min (3.5 mA for 2 min), +
Ocular iontophoresis 7 mA-min (3.5 mA for 2 minutes), positive polarity
干预措施: Citrate buffer (Drug)
6: 8 mA-min (4 mA for 2 min), + polarity
Ocular iontophoresis 8 mA-min (4 mA for 2 minutes), positive polarity
干预措施: EyeGate II® Drug Delivery System (Other)
7: 7 mA-min (3.5 mA for 2 min), -
7 mA-min (3.5 mA for 2 minutes), negative polarity
干预措施: EyeGate II® Drug Delivery System (Other)
7: 7 mA-min (3.5 mA for 2 min), -
7 mA-min (3.5 mA for 2 minutes), negative polarity
干预措施: Citrate buffer (Drug)
8: 8 mA-min (4 mA for 2 min), - polarity
Ocular iontophoresis 8 mA-min (4 mA for 2 minutes), negative polarity
干预措施: EyeGate II® Drug Delivery System (Other)
8: 8 mA-min (4 mA for 2 min), - polarity
Ocular iontophoresis 8 mA-min (4 mA for 2 minutes), negative polarity
干预措施: Citrate buffer (Drug)
9: 20 mA-min (4 mA for 5 min), +
Ocular iontophoresis 20 mA-min (4 mA for 5 minutes), positive polarity
干预措施: EyeGate II® Drug Delivery System (Other)
9: 20 mA-min (4 mA for 5 min), +
Ocular iontophoresis 20 mA-min (4 mA for 5 minutes), positive polarity
干预措施: Citrate buffer (Drug)
10: 20 mA-min (2 mA for 10 min), +
Ocular iontophoresis 20 mA-min (2 mA for 10 minutes), positive polarity
干预措施: EyeGate II® Drug Delivery System (Other)
10: 20 mA-min (2 mA for 10 min), +
Ocular iontophoresis 20 mA-min (2 mA for 10 minutes), positive polarity
干预措施: Citrate buffer (Drug)
11: 20 mA-min (4 mA for 5 min), -
Ocular iontophoresis 20 mA-min (4 mA for 5 minutes), negative polarity
干预措施: EyeGate II® Drug Delivery System (Other)
11: 20 mA-min (4 mA for 5 min), -
Ocular iontophoresis 20 mA-min (4 mA for 5 minutes), negative polarity
干预措施: Citrate buffer (Drug)
12: 20 mA-min (2 mA for 10 min), -
Ocular iontophoresis 20 mA-min (2 mA for 10 minutes), negative polarity
干预措施: EyeGate II® Drug Delivery System (Other)
12: 20 mA-min (2 mA for 10 min), -
Ocular iontophoresis 20 mA-min (2 mA for 10 minutes), negative polarity
干预措施: Citrate buffer (Drug)
13: 0 mA-min (0 mA for 10.5 min)
Ocular iontophoresis 0 mA-min (0 mA for 10.5 minutes)
干预措施: EyeGate II® Drug Delivery System (Other)
13: 0 mA-min (0 mA for 10.5 min)
Ocular iontophoresis 0 mA-min (0 mA for 10.5 minutes)
干预措施: Citrate buffer (Drug)
14: 13.5 mA-min (4.5 mA for 3 min), +
Ocular iontophoresis 13.5 mA-min (4.5 mA for 3 minutes), positive polarity
干预措施: EyeGate II® Drug Delivery System (Other)
14: 13.5 mA-min (4.5 mA for 3 min), +
Ocular iontophoresis 13.5 mA-min (4.5 mA for 3 minutes), positive polarity
干预措施: Citrate buffer (Drug)
15: 15 mA-min (5 mA for 3 min), +
Ocular iontophoresis 15 mA-min (5 mA for 3 minutes), positive polarity
干预措施: EyeGate II® Drug Delivery System (Other)
15: 15 mA-min (5 mA for 3 min), +
Ocular iontophoresis 15 mA-min (5 mA for 3 minutes), positive polarity
干预措施: Citrate buffer (Drug)
16: 16.5 mA-min (5.5 mA for 3 min), +
Ocular iontophoresis 16.5 mA-min (5.5 mA for 3 minutes), positive polarity
干预措施: EyeGate II® Drug Delivery System (Other)
16: 16.5 mA-min (5.5 mA for 3 min), +
Ocular iontophoresis 16.5 mA-min (5.5 mA for 3 minutes), positive polarity
干预措施: Citrate buffer (Drug)
17: 18 mA-min (6 mA for 3 min), +
Ocular iontophoresis 18 mA-min (6 mA for 3 minutes), positive polarity
干预措施: EyeGate II® Drug Delivery System (Other)
17: 18 mA-min (6 mA for 3 min), +
Ocular iontophoresis 18 mA-min (6 mA for 3 minutes), positive polarity
干预措施: Citrate buffer (Drug)
18: 19.5 mA-min (6.5 mA for 3 min), +
Ocular iontophoresis 19.5 mA-min (6.5 mA for 3 minutes), positive polarity
干预措施: EyeGate II® Drug Delivery System (Other)
18: 19.5 mA-min (6.5 mA for 3 min), +
Ocular iontophoresis 19.5 mA-min (6.5 mA for 3 minutes), positive polarity
干预措施: Citrate buffer (Drug)
19: 20 mA-min (7 mA for 3.84 min), +
Ocular iontophoresis 20 mA-min (7 mA for 3.84 minutes), positive polarity
干预措施: EyeGate II® Drug Delivery System (Other)
19: 20 mA-min (7 mA for 3.84 min), +
Ocular iontophoresis 20 mA-min (7 mA for 3.84 minutes), positive polarity
干预措施: Citrate buffer (Drug)
结局指标
主要结局
Safety assessed through patient reported adverse events
时间窗: Prospective
次要结局
- Ophthalmic examinations(Prospective)
- Ocular discomfort on a visual analog scale (VAS)(Prospective)