NCT03235232已完成3 期
Randomized Clinical Trial to Compare the Efficacy and Safety of BREMEN Eye Drops Versus Combigan in Subjects With Open Angle Glaucoma or Ocular Hypertension
EMS1 个研究点 分布在 1 个国家目标入组 406 人开始时间: 2021年2月1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
- 406
- 试验地点
- 1
- 主要终点
- Efficacy based in the reduction of intraocular pressure in patients with open-angle glaucoma or hypertension ocular.
研究概览
简要总结
The purpose of this study is to evaluate the clinical efficacy of the BREMEN eye drops in the treatment of primary open-angle glaucoma or intraocular 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 (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
- •Signed Consent;
- •Participants with diagnosis of open-angle glaucoma or hypertension ocular, who needs treatment with drugs association to control the intraocular pressure;
- •Participants who have 20/80 visual acuity or more, in both eyes;
排除标准
- •Participants with any clinical significant disease that, after evaluation of the investigator, can´t participate in the study;
- •Participants with active eye disease, which in the investigator opinion may interfere in the results of this clinical trial;
- •Participants presenting previous diagnosis of non-operated cataract, high myopia, high astigmatism, pseudoexfoliation and corneal deformities;
- •Participants who had significant visual loss in the last year;
- •Treatment-naive participants for open-angle glaucoma or ocular hypertension;
- •Participants nonresponders to previous triple combination drug therapy, used in concomitance;
- •Participants with previous ocular or intraocular surgery within six months prior to enrollment in the clinical trial;
- •Participants with history of hypersensitivity to any formula compounds;
- •Participants presenting contraindications to use of beta-adrenergic antagonists;
- •Participants diagnosed with uncontrolled cardiovascular disease;
- •Participants with severe renal insufficiency or hyperchloremic acidosis;
- •Participants in therapy with monoamine oxidase inhibitors (MAOIs);
- •Participants who were in use of drugs that can interfere in the evaluation;
- •Pregnancy or risk of pregnancy and lactating patients;
- •Alcoholism or illicit drug abuse in the last two years;
- •Participation in clinical trial in the year prior to this study.
研究组 & 干预措施
BREMEN eye drops
Experimental
1 drop in affected eye(s), each 12 hours for 8 weeks.
干预措施: BREMEN eye drops (Drug)
Combigan®
Active Comparator
1 drop of Combigan® in affected eye(s), each 12 hours for 8 weeks.
干预措施: Combigan® (Drug)
结局指标
主要结局
Efficacy based in the reduction of intraocular pressure in patients with open-angle glaucoma or hypertension ocular.
时间窗: 8 weeks
次要结局
- Safety will be evaluated through the adverse events occurrences(8 weeks)
研究者
研究点 (1)
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