Phase 3, Randomized, Adaptive Dose-Selection, Multi-regional, Double-Masked, Parallel-Group, 3-Month Trial Evaluating the Safety and Efficacy of NCX 470 vs. Latanoprost 0.005% in Subjects With Open-Angle Glaucoma or Ocular Hypertension (Mont Blanc)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 691
- 试验地点
- 1
- 主要终点
- Mean IOP Reduction From Time-Matched Baseline at the 8AM and 4PM Time-Points at Week 2, Week 6, and Month 3
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. In the adaptive dose selection phase of the trial, subjects will be randomized in a 1:1:1 ratio to one of two doses of NCX 470 (0.065% or 0.1%) or to latanoprost 0.005%. Following the selection of one dose of NCX 470, subjects will be randomized in a 1:1 ratio to the chosen dose of NCX 470 or to latanoprost 0.005%.
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 0.065%
NCX 470 Ophthalmic Solution, 0.065% dosed once daily to both eyes (initial phase of trial)
干预措施: NCX 470 0.065% (initial phase of trial) (Drug)
NCX 470 0.1%
NCX 470 Ophthalmic Solution, 0.1% dosed once daily to both eyes (initial phase of trial)
干预措施: NCX 470 0.1% (initial phase of trial) (Drug)
Latanoprost 0.005%
Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes (initial phase of trial)
干预措施: Latanoprost 0.005% (initial phase of trial) (Drug)
NCX 470 0.1% (remainder of trial)
NCX 470 Ophthalmic Solution, 0.1% dosed once daily to both eyes (chosen dose of NCX 470 to continue in remainder of trial)
干预措施: NCX 470 0.1% (remainder of trial) (Drug)
Latanoprost 0.005% (remainder of trial)
Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes (active comparator for remainder of trial)
干预措施: Latanoprost 0.005% (remainder of trial) (Drug)
结局指标
主要结局
Mean IOP Reduction From Time-Matched Baseline at the 8AM and 4PM Time-Points at Week 2, Week 6, and Month 3
时间窗: Baseline, Week 2, Week 6, and Month 3
The analysis performed as part of the Adaptive Dose Phase of the study was to evaluate the efficacy and safety of both concentrations of NCX 470 compared to Latanoprost. The primary endpoint for the interim analysis was mean diurnal IOP. Subsequent to the interim analysis at Week 2, the NCX 470 0.065% arm was discontinued and the primary analysis only included NCX 470 0.1% vs Latanoprost. The primary efficacy outcome results are reported for the NCX 470 0.1% and Latanoprost 0.005% treatment groups at Week 2, Week 6, and Month 3. As prespecified in the Statistical Analysis Plan, mean change from baseline in time-matched IOP was not calculated for the 0.065% group. The study eye was defined as the eye with the highest mean diurnal intraocular pressure (IOP) value at baseline (or right eye if both eyes had the same IOP value at baseline). The fellow eye was followed for safety.
次要结局
- Reduction From Baseline in Mean Diurnal IOP at Week 2, Week 6, and Month 3 in the Study Eye(Baseline, Week 2, Week 6, and Month 3)
- Number of Subjects With Treatment Emergent Adverse Events (TEAE) by Treatment Group in the Safety Population(3 months)
- Rate of Discontinuation(3 months)