Safety and Efficacy of a Glaucoma Drug Delivery System
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 主要终点
- Visual Acuity - Right Eye
研究概览
简要总结
The purpose of this study is to evaluate the ocular safety and efficacy of a glaucoma drug delivery system in open-angle glaucoma or ocular hypertension.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man or woman 21 years of age or greater
- •must have open angle glaucoma or ocular hypertension.
- •Corrected visual acuity in each eye of 20/200 or better.
排除标准
- •Previous glaucoma intraocular surgery or refractive surgery.
- •Planned contact lens use during the study.
- •Clinically significant ocular or systemic disease that might interfere with the study.
- •Use of chronic corticosteroids by any route.
研究组 & 干预措施
High Dose Device
device worn continuously for 14 days
干预措施: High Dose Device (Drug)
Low Dose Device
device worn continuously for 14 days
干预措施: Low Dose Device (Drug)
Placebo Device
device worn continuously for 14 days
干预措施: Placebo Device (Device)
结局指标
主要结局
Visual Acuity - Right Eye
时间窗: at 14 days
This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR). The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.
Visual Acuity - Left Eye
时间窗: at 14 days
This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR. The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.
次要结局
- Intraocular Pressure (IOP)(from baseline to 14 days)