NCT02617459已完成3 期
A Multicenter, Randomized, Open-label, Positive-controlled, Parallel-group Clinical Trial of Levobetaxolol Hydrochloride Eye Drops in Patients With Primary Open-angle Glaucoma or Ocular Hypertension
Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.1 个研究点 分布在 1 个国家目标入组 366 人开始时间: 2019年1月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 366
- 试验地点
- 1
- 主要终点
- Change in intraocular pressure (IOP) from baseline at week 8 after the treatment (a.m.)
研究概览
简要总结
To evaluate the safety and efficacy of Levobetaxolol in Chinese patients with glaucoma.
详细描述
To evaluate the safety and efficacy of Levobetaxolol in Chinese patients with primary 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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Agreed to participate in this clinical trial and informed consent;
- •Aged 18 to 70 years of age, male or female;
- •In line with primary open-angle glaucoma diagnostic criteria, IOP ≥18mmHg;
- •or in compliance with ocular hypertension diagnostic criteria, intraocular pressure> 21mmHg
排除标准
- •Known or suspected to be allergic to investigational drugs and materials
- •has been diagnosed with angle-closure glaucoma, absolute glaucoma, glaucoma ciliary body syndrome, secondary glaucoma.
- •merge various retinal lesions, such as retinal detachment, retinal vein occlusion, retinitis pigmentosa.
- •merge associated with eye infections or cornea, iris, lens obvious lesions, or one-eyed patients.
- •During the trial who must wear contact lenses, or nearly three months experts any eye surgery or laser treatment.
- •Need systemic β-blocker therapy during the study.
- •with severe kidney disease, or abnormal liver function tests (ALT, AST≥ 1.5 times the upper limit of normal, SCr> upper limit of normal).
- •merge sinus bradycardia, over Ⅰ degree atrioventricular block, cardiogenic shock, heart failure, symptomatic hypotension or other serious heart, lung diseases (such as bronchial asthma or a history of bronchial asthma, chronic obstructive lung disease, bronchospasm, respiratory failure, etc.).
- •merge hyperthyroidism, myasthenia gravis, diabetes, advanced cancer, blood and hematopoietic system diseases, or other serious or progressive disease systems.
- •associated with neurological and psychiatric disorders
- •suspect or indeed alcohol, drug abuse history.
- •pregnancy, lactation or recent fertility planner.
- •The researchers believe other circumstances were not involved in this trial.
- •participate in other clinical trials within three months.
研究组 & 干预措施
Levobetaxolol eye drops
Experimental
Levobetaxolol eye drops 5ml/25mg per bottle
干预措施: Levobetaxolol eye drops (Drug)
Betaxolol eye drops
Active Comparator
Betaxolol eye drops 5ml/12.5mg per bottle
干预措施: Betaxolol eye drops (Drug)
结局指标
主要结局
Change in intraocular pressure (IOP) from baseline at week 8 after the treatment (a.m.)
时间窗: 8 weeks
Change in intraocular pressure (IOP) from baseline at week 8 after the treatment (a.m.)
次要结局
- Change in intraocular pressure (IOP) from baseline to week 8 (p.m.)(8 weeks)
- Change in intraocular pressure (IOP) from baseline to week 2(2 weeks)
- Change from baseline in mean visual field defect (MD) at 8 weeks after the treatment(8 weeks)
- Change in retinal nerve fiber layer (RNFL) thickness from baseline at 8 weeks after the treatment(8 weeks)
- Change in visual acuity test at week 4(4 weeks)
- Change in intraocular pressure (IOP) from baseline to week 4(4 weeks)
- Change in visual acuity test at week 2(2 weeks)
- Change in visual acuity test at week 8(8 weeks)
- Change in visual field pattern standard deviation (PSD) from baseline at 8 weeks after the treatment(8 weeks)
研究者
研究点 (1)
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