Multicenter, Randomized, Double-masked Trial to Evaluate the Safety and Efficacy of iDose® TR (Travoprost Intraocular Implant) in Conjunction With the Placement of iStent Infinite in Subjects With Open-angle Glaucoma or Ocular Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- change from baseline in mean diurnal intraocular pressure (IOP)
研究概览
简要总结
Adult subjects with elevated intraocular pressure will be randomized to receive iStent infinite trabecular bypass system plus a travoprost intraocular implant or receive a sham procedure plus a travoprost intraocular implant and be followed for 12 months.
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, Outcomes Assessor)
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
- •diagnosis of open-angle glaucoma or ocular hypertension
- •qualifying IOP in the study eye
排除标准
- •unmedicated (washed out) IOP of >36 mmHg in the study eye
- •hypersensitivity to travoprost or any other components of the travoprost intraocular implant
- •vertical cup/disc ratio > 0.8 in the study eye
- •best spectacle corrected visual acuity of worse than 20/80 in either eye
- •any ocular disease or condition that, in the opinion of the investigator, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
研究组 & 干预措施
iDose TR
Travoprost Intraocular Implant in subjects who had successful iStent infinite placement
干预措施: iStent infinite (Device)
iDose TR alone
Travoprost Intraocular Implant
干预措施: Sham procedure (Other)
iDose TR
Travoprost Intraocular Implant in subjects who had successful iStent infinite placement
干预措施: Travoprost Intraocular Implant (Drug)
iDose TR alone
Travoprost Intraocular Implant
干预措施: Travoprost Intraocular Implant (Drug)
结局指标
主要结局
change from baseline in mean diurnal intraocular pressure (IOP)
时间窗: 3 months
mean diurnal IOP at the 3 month visit minus mean diurnal IOP at baseline
次要结局
未报告次要终点