A Multi-Center, Three-Stage, Open-Label, Prospective, Active-Comparator-Controlled Phase 2a Study of ENV515 (Travoprost) Intracameral Implant in Patients With Bilateral Ocular Hypertension or Early Primary Open-Angle Glaucoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 主要终点
- Summary of Change From Baseline Average Intraocular Pressure Diurnal Measurement by Treatment Group Population (Cohort 1)
研究概览
简要总结
This is a multiple cohort study that will evaluate the safety and efficacy of ENV515 travoprost XR in patients with open-angle glaucoma or ocular hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of either ocular hypertension or open angle glaucoma in both eyes.
- •Are currently treated with topical PGA for ocular hypertension in both eyes.
- •Patients who in the opinion of the Investigator: have an IOP in both eyes that is considered to be adequately controlled, can be safely withdrawn from IOP medications in both eyes during the washout period, and who are not considered to be at significant risk for disease progression throughout the trial.
排除标准
- •Eye surgery (including cataract surgery) within the past 3 months.
- •History of glaucoma related surgery.
研究组 & 干预措施
Cohort 1
ENV515-1 and ENV515-3 implants in Study Eye for 28 days
干预措施: ENV515-3 Travoprost XR (Drug)
Cohort 1
ENV515-1 and ENV515-3 implants in Study Eye for 28 days
干预措施: ENV515-1 Travoprost XR (Drug)
Cohort 2
Two ENV515-3 implants in Study Eye for 12 months with optional 6 month and 3 month extensions (total of 21 months)
干预措施: ENV515-3 Travoprost XR (Drug)
Cohort 3
One or two ENV515-3-2 implants in Study Eye with optional 6 months and additional 6 month extension (total of 24 months)
干预措施: ENV515-3-2 Travoprost XR (Drug)
结局指标
主要结局
Summary of Change From Baseline Average Intraocular Pressure Diurnal Measurement by Treatment Group Population (Cohort 1)
时间窗: Baseline and Day 25
Average intraocular pressure (IOP) diurnal measurement is calculated by taking the average of the intraocular pressure measurements at 8AM, 10AM and 4PM. The protocol was later amended (Amendment 09) to a safety only study so the diurnal measurements were no longer collected for Cohorts 2 and 3; only the 8AM IOP was collected as a safety assessment only.
次要结局
未报告次要终点