NCT06394973已完成2 期
Efficacy and Safety Assessment of T4090 Ophthalmic Solution (Preservative-free Kinezodianone R HCl 0.2% or 0.3%) Versus Rhopressa® Ophthalmic Solution (Preserved Netarsudil 0.02%) in Patients With Open-angle Glaucoma or Ocular Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 161
- 试验地点
- 23
- 主要终点
- Mean Diurnal IOP
研究概览
简要总结
The main purpose is to compare the ocular hypotensive efficacy and safety of two concentrations of T4090 (Kinezodianone R HCl 0.2% and 0.3%) ophthalmic solution with Rhopressa® 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
- Single (Investigator)
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
- •Patient (male or female) ≥18 years old
- •Patient with Open Angle Glaucoma or Ocular Hypertension in both eyes
- •Informed consent dated and signed.
排除标准
- •Secondary Open Agle Glaucoma (ex. Pseudoexfoliation, Pigmentary glaucoma)
- •Advanced stage of glaucoma
- •History of ocular trauma, eye infection, or/and ocular clinically significant inflammation within the 6 previous months.
- •Known or suspected hypersensitivity to one of the components of the IMPs or other product used in the clinical study
- •Pregnancy (confirmed with a positive urine pregnancy test) or breast-feeding.
研究组 & 干预措施
T4090 0.2%
Experimental
干预措施: T4090 0.2% (Drug)
T4090 0.3%
Experimental
干预措施: T4090 0.3% (Drug)
Rhopressa®
Active Comparator
干预措施: Rhopressa® (Drug)
结局指标
主要结局
Mean Diurnal IOP
时间窗: The primary efficacy endpoint is the change from baseline (D1) at Week 7 in the mean diurnal IOP in the study eye.
IOP measurement with calibrated Goldmann applanation tonometer in each eye at three time points (8:00 AM; 10:00 AM; 4:00 PM) by the Investigator. Mean diurnal is calculated from these three timepoints.
次要结局
未报告次要终点
研究者
研究点 (23)
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