Prospective, Randomized Phase II Study Comparing Two Elution Rates of Glaukos Travoprost Intraocular Implants to Timolol Maleate Ophthalmic Solution, USP 0.5%
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- IOP (mmHg) Change From Baseline at Week 12
研究概览
简要总结
This is a randomized trial comparing two elution doses of the Travoprost Intraocular implant to timolol ophthalmic solution.
详细描述
This is a randomized trial comparing two elution doses of the Travoprost Intraocular implant to timolol ophthalmic solution in patients with open-angle glaucoma. Study assessments will include IOP and medication use as well as safety parameters.
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
- •Open angle glaucoma
排除标准
- •Uveitic, neovascular, or angle closure glaucoma; or glaucoma associated with vascular disorders.
- •Functionally significant visual field loss, including severe nerve fiber bundle defects.
- •Prior glaucoma surgery.
- •Uncontrolled systemic disease, pregnant females or those planning a pregnancy.
- •Other ocular status conditions, etc.
研究组 & 干预措施
Travoprost Intraocular Implant, high elution
This implant will be surgically implanted and elute travoprost, a prostaglandin.
干预措施: Travoprost Intraocular Implant, high elution (Drug)
Travoprost Intraocular Implant, low elution
This implant will be surgically implanted and elute travoprost, a prostaglandin.
干预措施: Travoprost Intraocular Implant, low elution (Drug)
Timolol Maleate Ophthalmic Solution, 0.5%
Timolol, a beta blocker, will be dosed twice daily
干预措施: Timolol Maleate Ophthalmic Solution, 0.5% (Drug)
结局指标
主要结局
IOP (mmHg) Change From Baseline at Week 12
时间窗: 12 weeks
Change from baseline in IOP (measured in mmHg) at week 12. Negative values represent reductions in IOP from baseline.
次要结局
未报告次要终点