Quality of 24-hour Intraocular Pressure Control Obtained With Dorzolamide/Timolol Fixed Combination (DTFC) Compared With the Brimonidine/Timolol Fixed Combination (BTFC) in Subjects With Primary Open-angle Glaucoma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- To compare the quality of 24-hour IOP control after 2 months of chronic therapy with the Dorzolamide/Timolol fixed combination versus the Brimonidine/Timolol fixed combination in primary open-angle glaucoma.
研究概览
简要总结
The proposed study will compare for the first time the quality of 24-hour IOP control with Brimonidine/Timolol fixed combination (BTFC) versus Dorzolamide/Timolol fixed combination (DTFC) after a run-in period of 2 months with timolol. This crossover comparison may determine the real efficacy of the two fixed combinations and the design of the proposed study may explain for the first time why the 24-hour IOP reduction provided by BTFC is less than might be anticipated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 29 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive, newly diagnosed or previously untreated POAG patients
- •Patients with typical glaucomatous disc, or visual field damage
- •Patient must have IOP (at 10:00 ± 1 hour)greater than 25 mm Hg
排除标准
- •Uncontrolled glaucoma
- •Distance best corrected Snellen visual acuity worse than 1/10
- •Contraindications to brimonidine or dorzolamide and β-blockers
- •History of lack of response (<10% morning IOP reduction) to any medication
- •Patient can not understand the instructions and adhere to medications
- •Patient is a female of childbearing potential or lactating mother
- •Prior surgery, past use of steroids (within 2 months)
- •Severe dry eyes and use of contact lenses
- •History of non-adherence
- •Patients with closed angles
研究组 & 干预措施
Drug: Dorzolamide/Timolol
干预措施: treatment with dorzolamide/timolol (Drug)
Treatment with Brimonidine/Timolol
干预措施: treatment with brimonidine/timolol (Drug)
结局指标
主要结局
To compare the quality of 24-hour IOP control after 2 months of chronic therapy with the Dorzolamide/Timolol fixed combination versus the Brimonidine/Timolol fixed combination in primary open-angle glaucoma.
时间窗: 3 months
次要结局
- Assess fluctuation of 24-hour pressure(3 months)
研究者
AGP Konstas
Professor in Ophthalmology
Aristotle University Of Thessaloniki