Multicenter, Randomized, Double-masked, Parallel Group Trial to Evaluate the Safety and Efficacy of iDose® TR (Travoprost Intracameral Implant) in Conjunction With Cataract Surgery vs. Cataract Surgery Alone
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Change from baseline in mean diurnal IOP
研究概览
简要总结
This trial will evaluate the safety and IOP -lowering efficacy of administering an iDose TR (travoprost intracameral implant) in conjunction with cataract surgery compared to cataract surgery alone
详细描述
This is a Phase 4 randomized, double-masked, parallel group trial designed to evaluate the safety and IOP-lowering efficacy of administering iDose TR (travoprost intracameral implant 75 mcg) in conjunction with uncomplicated cataract surgery (phacoemulsification with a posterior chamber intraocular lens) compared to uncomplicated cataract surgery alone, in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cataract diagnosis: clinically significant age-related cataract eligible for phacoemulsification in the study eye.
- •OAG or OHT diagnosis: either OAG (i.e. primary, pseudoexfoliation, or pigmentary glaucoma) or OHT in the study eye (i.e., eye to undergo cataract surgery)
排除标准
- •Active corneal inflammation or edema.
- •Retinal disorders not associated with glaucoma.
研究组 & 干预措施
iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery
iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery
干预措施: iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery (Combination Product)
Sham procedure in conjunction with cataract surgery
Sham procedure in conjunction with cataract surgery
干预措施: Sham procedure in conjunction with cataract surgery (Procedure)
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 mean diurnal IOP at the Baseline Visit
次要结局
未报告次要终点