NCT04630808已完成3 期
A Phase 3, Randomized, Multi-Regional, Double-Masked, Parallel-Group Trial Evaluating the Safety and Efficacy of NCX 470 0.1% vs. Latanoprost 0.005% in Subjects With Open-Angle Glaucoma or Ocular Hypertension (Denali)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 696
- 试验地点
- 1
- 主要终点
- Change from baseline IOP
研究概览
简要总结
The objective of this clinical study is to evaluate the safety and efficacy of NCX 470 Ophthalmic Solution in lowering intraocular pressure (IOP) in subjecs with ocular hypertension or open-angle glaucoma. Subjects will be randomized in a 1:1 ratio to NCX 470 0.1% or to latanoprost 0.005% to be administered to both eyes once daily in the evening for up to 12 months.
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, Investigator)
盲法说明
double-masked
入排标准
- 年龄范围
- 18 Years 至 84 Years（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 both eyes
- •Qualifying IOP at 3 time points through the day at 2 visits following washout of IOP-lowering medication, if applicable
- •Qualifying best-corrected visual acuity in each eye
- •Ability to provide informed consent and follow study instructions
排除标准
- •Narrow anterior chamber angles or disqualifying corneal thickness in either eye
- •Clinically significant ocular disease in either eye
- •Previous complicated surgery or certain types of glaucoma surgery in either eye
- •Incisional ocular surgery or severe trauma in either eye within the past 6 months
- •Uncontrolled systemic disease
研究组 & 干预措施
NCX 470 0.1%
Experimental
NCX 470 Ophthalmic Solution, 0.1% dosed once daily to both eyes
干预措施: NCX 470 0.1% (Drug)
Latanoprost 0.005%
Active Comparator
Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes
干预措施: Latanoprost 0.005% (Drug)
结局指标
主要结局
Change from baseline IOP
时间窗: Up to 3 months
Mean IOP change from time-matched baseline at 8AM and 4PM time points at the Week 2, Week 6 and Month 3 Visits in the study eye
次要结局
- Change from baseline in diurnal IOP(Up to 3 months)
- Frequency and incidence of treatment-emergent adverse events(12 months)
- Rate of discontinuation(12 months)
研究者
研究点 (1)
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