Comparing Efficacy and Safety of Combigan With Timolol Adjunctive to Xalatan in Glaucoma or Ocular Hypertension Subjects
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 204
- 主要终点
- Mean Intraocular Pressure (IOP) at 10 AM at Week 12
研究概览
简要总结
Efficacy and safety evaluation of Combigan with timolol when each is used as adjunctive therapy to Xalatan in subjects with 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 (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
- •History of severe renal or hepatic impairment
- •Subjects with severe cardiovascular disease should not be enrolled unless their disease is controlled and clearance has been obtained from the subject's primary care physician and/or cardiologist
- •Contraindications to beta-adrenoceptor antagonist therapy such as chronic obstructive pulmonary disease, bronchial asthma, sinus bradycardia, second and third degree atrioventricular block, overt cardiac failure and cardiogenic shock or uncontrolled congestive heart failure
- •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
Combigan ®
Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%) adjunctive to Xalatan® (latanoprost 0.005%)
干预措施: Fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% (Drug)
Combigan ®
Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%) adjunctive to Xalatan® (latanoprost 0.005%)
干预措施: latanoprost 0.005% (Drug)
Timolol Maleate 0.5%
Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
干预措施: timolol maleate 0.5% (Drug)
Timolol Maleate 0.5%
Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
干预措施: latanoprost 0.005% (Drug)
结局指标
主要结局
Mean Intraocular Pressure (IOP) at 10 AM at Week 12
时间窗: Week 12
Mean IOP at 10 AM at week 12. IOP is a measurement of the fluid pressure in the eye.
次要结局
- Mean Intraocular Pressure (IOP) at 10 AM at Week 6(Week 6)
- Mean Intraocular Pressure (IOP) at 8 AM at Week 12(Week 12)
- Mean Intraocular Pressure (IOP) at 8 AM at Week 6(Week 6)
- Number of Subjects With Adverse Events(Week 12)