NCT05503901已完成3 期
An Open-Label, Long-Term Phase III Study of STN1012600 Ophthalmic Solution Alone and in Combination With Timolol Ophthalmic Solution, in Subjects With Open Angle Glaucoma or Ocular Hypertension (Angel-J2 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
- 131
- 试验地点
- 18
- 主要终点
- Change from baseline in mean diurnal intraocular pressure
研究概览
简要总结
To evaluate safety and the ocular hypotensive effect of STN1012600 ophthalmic solution 0.002% alone or in combination with Timolol ophthalmic solution 0.5% for 52 weeks in subjects with open angle glaucoma or ocular hypertension.
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
- None
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 OAG or OHT in both eyes, or one eye with OAG 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
Group 1: STN1012600 0.002%
Experimental
干预措施: STN1012600 ophthalmic solution 0.002% (Drug)
Group 2: STN1012600 0.002%
Experimental
干预措施: STN1012600 ophthalmic solution 0.002% (Drug)
Group 3: STN1012600 0.002% + Timolol 0.5%
Experimental
干预措施: STN1012600 ophthalmic solution 0.002% and Timolol ophthalmic solution 0.5% (Drug)
结局指标
主要结局
Change from baseline in mean diurnal intraocular pressure
时间窗: 52 weeks
Change from baseline in mean diurnal intraocular pressure at each post-baseline visit
Percent change from baseline in mean diurnal intraocular pressure
时间窗: 52 weeks
Percent change from baseline in mean diurnal intraocular pressure at each post-baseline visit
次要结局
未报告次要终点
研究者
研究点 (18)
Loading locations...
相似试验
已完成
2 期
A Multicenter Study Assessing the Efficacy and Safety of STN1010904 Ophthalmic Suspension 0.03% and 0.1% Compared With Vehicle in Subjects With Fuchs Endothelial Corneal Dystrophy (FECD)Fuchs Endothelial Corneal DystrophyNCT05376176Santen Inc.86
已完成
2 期
Study Assessing the Efficacy and Safety of STN1013600 Ophthalmic Solution 0.1% and 0.3% Compared With Placebo in Subjects With PresbyopiaPresbyopiaNCT05665387Santen Inc.79
已完成
3 期
A Comparative Confirmatory Study of STN1012600 in Subjects With Primary Open Angle Glaucoma or Ocular HypertensionPrimary Open Angle Glaucoma, Ocular HypertensionNCT05495061Santen Pharmaceutical Co., Ltd.325
招募中
1 期
A phase I/IIa study of STN1014100 ophthalmic solution in healthy adult male volunteers and dry eye patientsDry eyeJPRN-jRCT2051220152Koji Oka134
已完成
1 期
A phase I study of STN1013400 ophthalmic solution in healthy adult male volunteerMyopiaJPRN-jRCT2031210208Migita Yukie48