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 vs. iStent Infinite Alone in Subjects With Open-angle Glaucoma or Ocular Hypertension
概览
- 阶段
- 3 期
- 干预措施
- Travoprost Intraocular Implant
- 疾病 / 适应症
- Glaucoma, Open-Angle
- 发起方
- Glaukos Corporation
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- change from baseline in mean diurnal intraocular pressure (IOP)
- 状态
- 招募中
- 最后更新
- 3个月前
概览
简要总结
Adult subjects with elevated intraocular pressure who have successfully undergone placement of iStent infinite trabecular bypass system will be randomized to receive a travoprost intraocular implant or receive a sham procedure and be followed for 12 months.
研究者
入排标准
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 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: Travoprost Intraocular Implant
iDose TR
Travoprost Intraocular Implant in subjects who had successful iStent infinite placement
干预措施: iStent infinite
sham procedure
Sham surgical procedure in subjects who had successful iStent infinite placement
干预措施: Sham procedure
sham procedure
Sham surgical procedure in subjects who had successful iStent infinite placement
干预措施: iStent infinite
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