NCT05495061已完成3 期
A Phase III, Randomized, Observer-Masked, Active-Controlled, Parallel-Group, Multicenter Study Assessing the Efficacy and Safety of STN1012600 Ophthalmic Solution 0.002% Compared With Latanoprost 0.005% in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension (Angel-J1 Study)
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
- 325
- 试验地点
- 44
- 主要终点
- Change from baseline in mean diurnal intraocular pressure
研究概览
简要总结
To investigate whether the IOP lowering efficacy of STN1012600 ophthalmic solution 0.002% is non-inferior to that of latanoprost 0.005% in subjects with POAG or OHT after treatment for 4 weeks.
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 (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
- •18 years of age or older.
- •Diagnosis of POAG or OHT in both eyes, or one eye with POAG and the other with OHT.
- •Corrected Visual Acuity of +0.60 logMAR (Decimal visual acuity 0.3) or better in each eye.
排除标准
- •Presence of any active severe external ocular disease, inflammation, or infection of the eye and/or eyelids in either eye.
- •History of severe ocular trauma in either eye.
- •Any condition that prevents clear visualization of the fundus in either eye.
- •Known allergy, hypersensitivity or contraindications to any components of the study medications or other study related procedures/medications.
- •History of ocular surgery specifically intended to lower IOP in either eye.
- •History of keratorefractive surgery in either eye.
- •Females who are pregnant, nursing, or planning a pregnancy.
- •Subjects with known or suspected drug or alcohol abuse.
- •Participation in other investigational drugs or device clinical trials within 30 days prior to Screening.
- •Any decision by the Investigator to terminate a subject in screening or declare any subject ineligible for any sound medical reason.
研究组 & 干预措施
STN1012600 0.002%
Experimental
干预措施: STN1012600 ophthalmic solution 0.002% (Drug)
Latanoprost 0.005%
Active Comparator
干预措施: Latanoprost ophthalmic solution 0.005% (Drug)
结局指标
主要结局
Change from baseline in mean diurnal intraocular pressure
时间窗: 4 weeks
Change from baseline in mean diurnal intraocular pressure at Week 4
次要结局
未报告次要终点
研究者
研究点 (44)
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