Phase 2/Phase 3 Trial to Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 610
- 试验地点
- 2
- 主要终点
- Intraocular pressure (IOP)
研究概览
简要总结
Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant
详细描述
Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant Compared to Timolol Ophthalmic Solution 0.5% Administered Twice Daily in Subjects with Open-Angle Glaucoma or Ocular Hypertension
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, 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 in the study eye
排除标准
- •Prior incisional glaucoma surgery in the study eye
- •Prior argon laser trabeculoplasty (ALT) in the study eye
- •Prior minimally invasive glaucoma (MIGS) surgery in the study eye
研究组 & 干预措施
Period 1 (Cohort A)
Single-arm, open-label portion of Phase 2; subjects will receive second generation travoprost intracameral implant (plus placebo eyedrops BID) in the study eye and be followed for 36 months
干预措施: Gen 2 Travoprost Intracameral Implant (Drug)
Period 2 (Cohort B) Gen 2 Travoprost Intracameral Implant Arm
Randomized, double-masked, active-controlled Phase 2 portion of the trial; subjects will receive second generation travoprost intracameral implant (plus placebo eyedrops BID) in the study eye and be followed for 36 months
干预措施: Gen 2 Travoprost Intracameral Implant (Drug)
Period 2 (Cohort B) Gen 2 Travoprost Intracameral Implant Arm
Randomized, double-masked, active-controlled Phase 2 portion of the trial; subjects will receive second generation travoprost intracameral implant (plus placebo eyedrops BID) in the study eye and be followed for 36 months
干预措施: Placebo eye drops (Other)
Period 2 (Cohort B) Timolol Arm
Randomized, double-masked, active-controlled, Phase 2 portion of the trial; subjects will administer timolol 0.5% eye drops BID (plus sham procedure) in the study eye and be followed for 36 months
干预措施: Timolol eye drops 0.5% (Drug)
Period 2 (Cohort B) Timolol Arm
Randomized, double-masked, active-controlled, Phase 2 portion of the trial; subjects will administer timolol 0.5% eye drops BID (plus sham procedure) in the study eye and be followed for 36 months
干预措施: Sham Procedure (Procedure)
Period 3 (Cohort X) Gen 2 Travoprost Intracameral Implant Arm
Randomized, double-masked, active-controlled, Phase 3 portion of the trial; subjects will receive second generation travoprost intracameral implant (plus placebo eyedrops BID) in the study eye and undergo an exchange procedure at month 12 and be followed for an additional 12 months
干预措施: Gen 2 Travoprost Intracameral Implant (Drug)
Period 3 (Cohort X) Gen 2 Travoprost Intracameral Implant Arm
Randomized, double-masked, active-controlled, Phase 3 portion of the trial; subjects will receive second generation travoprost intracameral implant (plus placebo eyedrops BID) in the study eye and undergo an exchange procedure at month 12 and be followed for an additional 12 months
干预措施: Placebo eye drops (Other)
Period 3 (Cohort X) Timolol Arm
Randomized, double-masked, active-controlled, Phase 3 portion of the trial; subjects will administer timolol 0.5% eye drops BID (plus sham procedure) in the study eye and undergo a sham exchange procedure at month 12 and be followed for an additional 12 months
干预措施: Timolol eye drops 0.5% (Drug)
Period 3 (Cohort X) Timolol Arm
Randomized, double-masked, active-controlled, Phase 3 portion of the trial; subjects will administer timolol 0.5% eye drops BID (plus sham procedure) in the study eye and undergo a sham exchange procedure at month 12 and be followed for an additional 12 months
干预措施: Sham Procedure (Procedure)
Period 3 (Cohort Y) Gen 2 Travoprost Intracameral Implant Arm
Randomized, double-masked, active-controlled, Phase 3 portion of the trial, subjects will receive second generation travoprost intracameral implant (plus placebo eyedrops BID) in the study eye and undergo an exchange procedure at month 24 and be followed for an additional 12 months
干预措施: Gen 2 Travoprost Intracameral Implant (Drug)
Period 3 (Cohort Y) Gen 2 Travoprost Intracameral Implant Arm
Randomized, double-masked, active-controlled, Phase 3 portion of the trial, subjects will receive second generation travoprost intracameral implant (plus placebo eyedrops BID) in the study eye and undergo an exchange procedure at month 24 and be followed for an additional 12 months
干预措施: Placebo eye drops (Other)
Period 3 (Cohort Y) Timolol Arm
Randomized, double-masked, active-controlled, Phase 3 portion of the trial; subjects will receive timolol 0.5% eye drops BID (plus sham procedure) in the study eye and undergo a sham exchange procedure at month 24 and be followed for an additional 12 months
干预措施: Timolol eye drops 0.5% (Drug)
Period 3 (Cohort Y) Timolol Arm
Randomized, double-masked, active-controlled, Phase 3 portion of the trial; subjects will receive timolol 0.5% eye drops BID (plus sham procedure) in the study eye and undergo a sham exchange procedure at month 24 and be followed for an additional 12 months
干预措施: Sham Procedure (Procedure)
Period 3 (Cohort Z) Gen 2 Travoprost Intracameral Implant Arm
Randomized, double-masked, active-controlled, Phase 3 portion of the trial, subjects will receive second generation travoprost intracameral implant (plus placebo eyedrops BID) in the study eye and undergo an exchange procedure at month 36 and be followed for an additional 12 months
干预措施: Gen 2 Travoprost Intracameral Implant (Drug)
Period 3 (Cohort Z) Timolol Arm
Randomized, double-masked, active-controlled, Phase 3 portion of the trial; subjects will administer timolol 0.5% eye drops BID (plus sham procedure) in the study eye and undergo an sham exchange procedure at month 36 and be followed for an additional 12 months
干预措施: Timolol eye drops 0.5% (Drug)
Period 3 (Cohort Z) Timolol Arm
Randomized, double-masked, active-controlled, Phase 3 portion of the trial; subjects will administer timolol 0.5% eye drops BID (plus sham procedure) in the study eye and undergo an sham exchange procedure at month 36 and be followed for an additional 12 months
干预措施: Placebo eye drops (Other)
结局指标
主要结局
Intraocular pressure (IOP)
时间窗: 3 months
Change from baseline in diurnal IOP in the study eye at 8AM and 10AM at each of Day 11, Week 6, and Month 3 visits
次要结局
未报告次要终点