Multicenter, Open-label, Single-arm Trial to Evaluate the Safety and Efficacy of iDose® TR (Travoprost Intraocular Implant) in Conjunction With Cataract Surgery
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from baseline in mean diurnal IOP
研究概览
简要总结
Subjects with cataract requiring extraction and who have open-angle glaucoma or ocular hypertension will undergo screening and washout from IOP-lowering medication, if applicable. Eligible subjects who meet all inclusion criteria and none of the exclusion criteria and who undergo successful cataract extraction with implantation of a posterior chamber intraocular lens (PC-IOL) will receive a travoprost intraocular implant and followed up for 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinically significant age-related cataract eligible for phacoemulsification in the study eye
- •open-angle glaucoma or ocular hypertension in the study eye
- •successful, uncomplicated cataract surgery using small incision phacoemulsification cataract surgery and insertion of a foldable posterior chamber IOL
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 the fellow 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 administered intracamerally in the study eye at the Day 1 Visit following successful cataract surgery
干预措施: iDose TR (Drug)
结局指标
主要结局
Change from baseline in mean diurnal IOP
时间窗: 3 months
Mean diurnal IOP at the Month 3 Visit minus the mean diurnal IOP at the Baseline Visit
次要结局
未报告次要终点