NCT01943721已完成1 期
A Study of the VISION5 Product in Patients With Glaucoma or Ocular Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Ocular Tonometry (change from baseline)
研究概览
简要总结
The objective of this Phase 1 study is to evaluate the VISION5 Product's safety and efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Primary open-angle glaucoma or ocular hypertension in both eyes
- •Best-corrected distance vision of 20/100 or better
- •Stable visual field
排除标准
- •Cup-to-disc ratio greater than 0.8
- •Laser surgery for glaucoma/ocular hypertension on one or both eyes within the last 12 months
- •Corneal refractive surgery within prior 6 months
- •Past history of any incisional surgery for glaucoma at any time
- •Corneal abnormalities that would interfere with tonometry readings
- •Current participation in an investigational drug or device study or participation in such a study within 30 days of screening
研究组 & 干预措施
VISION5 Product
Experimental
VISION5 Product in both eyes
干预措施: VISION5 Product (Drug)
结局指标
主要结局
Ocular Tonometry (change from baseline)
时间窗: Week 2, 6, 12 and Months 4,5,6
次要结局
- Safety as assessed by Slit Lamp Exam(Weeks 2,6,12 and Months 4,5,6)
研究者
研究点 (1)
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