Comparison of the Fixed Combinations of Brimonidine/Timolol and Dorzolamide/Timolol in Subjects With Open-Angle Glaucoma or Ocular Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 140
- 主要终点
- Change from baseline in mean IOP
研究概览
简要总结
This study compares the efficacy and tolerability/comfort of brimonidine/timolol and dorzolamide/timolol in patients with open-angle glaucoma or ocular hypertension. In an investigator masked randomisation process, each subject is allocated to received either brimonidine/timolol or dorzolamide/timolol as fixed-combination monotherapy or as an adjunctive to a prostaglandin analogue for a period of 12 weeks. After screening, patient returns at baseline, Month 1 and Month 3 for ophthalmic evaluations.
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
- •Male or female over 18 years
- •Female subjects of childbearing potential must have negative pregnancy test and practice contraception
- •Subjects must have confirmed diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes
- •Subjects who are or have been insufficiently responsive to IOP reducing monotherapy and use of either study medication is deemed appropriate
- •Subjects able to complete questionnaires and provide informed consent
排除标准
- •Female subjects who are pregnant, planning to become pregnant during study period, breast feeding or not practicing a reliable method of birth control
- •Subjects wherein the study drugs are contraindicated
- •Subjects who have had intraocular surgery with 6 months (3 months for laser)
- •Subjects with known side effects/allergy or sensitivity to any component of study treatments
- •Subjects with any uncontrolled systemic disease
研究组 & 干预措施
1
brimonidine/timolol Fixed-combination monotherapy
干预措施: brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination (Drug)
2
dorzolamide/timolol fixed-combination monotherapy
干预措施: dorzolamide hcl 2%/timolol maleate 0.5% fixed combination (Drug)
3
prostaglandin analogue + brimonidine/timolol fixed combination
干预措施: brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy (Drug)
4
prostaglandin analogue + dorzolamide/timolol fixed combination
干预措施: dorzolamide hcl 2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy (Drug)
结局指标
主要结局
Change from baseline in mean IOP
时间窗: 12 weeks
次要结局
- Patient tolerability/comfort measured by Likert scale(Month 1)