NCT00811564已完成4 期
An Evaluation of the Fixed Combination Brimonidine Tartrate 0.2%/ Timolol Maleate 0.5% to Latanoprost 0.005% in Glaucoma or Ocular Hypertension Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 148
- 主要终点
- Intraocular Pressure (IOP) at Week 12
研究概览
简要总结
A three-month evaluation comparing the safety and efficacy of a fixed combination of 0.2% brimonidine tartrate/0.5% timolol maleate with that of latanoprost 0.005%, a prostaglandin analogue in glaucoma or ocular hypertension subjects
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
- •Be at least 18 years of age;
- •Give written informed consent;
- •Be in good general health as determined by your doctor;
- •Have a diagnosis of unilateral or bilateral glaucoma or ocular hypertension;
- •If you are a female of child bearing potential, you must be willing to practice effective contraception for the duration of the study (i.e., abstinence, spermicide, condoms, or birth control pills);
- •Understand the study instructions, and be able to follow the study instructions; and
- •Be likely to complete the entire study period (12 weeks), including all regularly scheduled study visits.
排除标准
- •Have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study interpretation;
- •Any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results; and
- •Concurrent participation or prior participation in any investigational drug or device study within the last 30 days prior to the Screening Visit
研究组 & 干预措施
1
Active Comparator
Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution
干预措施: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution (Drug)
2
Active Comparator
Latanoprost 0.005% ophthalmic solution
干预措施: latanoprost 0.005% (Drug)
结局指标
主要结局
Intraocular Pressure (IOP) at Week 12
时间窗: Week 12
Mean IOP at week 12. IOP is a measurement of the fluid pressure inside the eye.
次要结局
未报告次要终点
研究者
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