A Phase 2, Randomized, Multicenter, Masked, Parrallel-Group, Dose-Response Study Evaluating the Safety and Efficacy of NCX 470 (3 Doses: 0.021%, 0.042%, and 0.065%) vs. Latanoprost 0.005% in Subjects With Open-Angle Glaucoma or Ocular Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 656
- 试验地点
- 1
- 主要终点
- Change From Baseline in Study Eye Mean Diurnal IOP at the Week 4
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 patients with ocular hypertension or open-angle glaucoma. Three different concentrations of NCX 470 ophthalmic solution (0.021%, 0.042%, and 0.065%) will be compared to latanoprost 0.005% ophthalmic solution.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 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 throughout the day at 2 visits following washout of IOP-lowering medication, if applicable
- •Qualifying best-corrected visual acuity (BCVA) using the Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol in each eye
- •Ability to provide informed consent and follow study instructions
排除标准
- •Pigmentary or pseudoexfoliative glaucoma
- •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 0.021%
NCX 470 Ophthalmic Solution, 0.021% dosed once daily for 4 weeks
干预措施: NCX 470 (Drug)
NCX 470 0.042%
NCX 470 Ophthalmic Solution, 0.042% dosed once daily for 4 weeks
干预措施: NCX 470 (Drug)
NCX 470 0.065%
NCX 470 Ophthalmic Solution, 0.065% dosed once daily for 4 weeks
干预措施: NCX 470 (Drug)
Latanoprost 0.005%
Latanoprost Ophthalmic Solution, 0.005% dosed once daily for 4 weeks
干预措施: Latanoprost 0.005% (Drug)
结局指标
主要结局
Change From Baseline in Study Eye Mean Diurnal IOP at the Week 4
时间窗: Baseline, Week 4
Participants used medication in both eyes for 4 weeks with one eye was designated the study eye at baseline. The study eye was defined as the eye with the highest mean diurnal intraocular pressure (IOP) value at baseline (or the right eye if both eyes had the same IOP value at baseline). Mean diurnal IOP at week 4 is the average of the 8AM, 10AM and 4PM IOPs at week 4.
次要结局
- Change From Baseline in Study Eye Mean Diurnal IOP at Week 1, Week 2, and Exit Visit(Baseline, week 1, week 2, exit visit)
- Percentage of Subjects With Treatment-emergent Ocular Adverse Events(4 weeks for adverse events and through 30 days post-treatment for serious adverse events)