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
- 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 randomization process, each subject is allocated to recieve either brimonidine/timolol or dorzolamide/timolol as fixed-combination monotherapy or as an adjuctive to a prostoglandin 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
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 yrs.
- •Female subjects of childbearing potential must have negative pregnancy test and provide 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 containdicated.
- •Subjects who have had introcular 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 combinatin 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)