A Proof of Concept Study to Assess the Safety and IOP-Lowering Effect of AL-59412C Injected Intravitreally
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 主要终点
- Maximum intraocular (IOP) reduction from baseline up to 24 hours post-injection
研究概览
简要总结
The purpose of this study was to assess the safety and efficacy of AL-59412C injected intravitreally relative to Vehicle.
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
- 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 primary open-angle glaucoma or ocular hypertension.
- •Retinal pathology (eg, retinal degeneration), anterior ischemic optic neuropathy, or vascular occlusion resulting in poor vision in the study eye.
- •Able to discontinue all intraocular-lowering (IOP) medications according to the minimum washout period, based upon the class of medication.
- •Mean washed out IOP ≥ 24 millimeters mercury (mmHg) to ≤ 36 mmHg at 8 AM in the study eye on two separate Eligibility Visits.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Lens/corneal/vitreal opacity preventing adequate posterior segment visualization of the study eye.
- •Current or recent (within 30 days) use of any drug that may prolong the QT interval.
- •Poor vision resulting from advanced glaucoma in the study eye.
- •Intraocular surgery within the past 6 months in the study eye.
- •Ocular laser surgery within the past 3 months in the study eye.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
AL-59412C Concentration 1
AL-59412C injectable solution, single intravitreal injection
干预措施: AL-59412C injectable solution (Drug)
AL-59412C Concentration 2
AL-59412C injectable solution, single intravitreal injection
干预措施: AL-59412C injectable solution (Drug)
Travoprost
Travoprost injectable solution, single intravitreal injection
干预措施: Travoprost injectable solution (Drug)
Vehicle
AL-59412C Vehicle, single intravitreal injection
干预措施: AL-59412C Vehicle (Drug)
结局指标
主要结局
Maximum intraocular (IOP) reduction from baseline up to 24 hours post-injection
时间窗: Time to event, up to 24 hours post-injection
IOP was measured by Goldman applanation tonometry at protocol-specified timepoints, up to 24 hours post-injection.
次要结局
未报告次要终点