Quality of 24-hour Intraocular Pressure Control Obtained With the Brinzolamide/Timolol Fixed Combination Compared With the Brimonidine/Timolol Fixed Combination When Added to Travoprost Monotherapy in Subjects With Open-angle Glaucoma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 51
- 主要终点
- Mean 24-hour intraocular pressure
研究概览
简要总结
The proposed crossover study will compare for the first time the quality of 24-hour intraocular pressure control with the combination of travoprost and brinzolamide/timolol compared with travoprost and brimonidine/timolol in glaucoma patients insufficiently controlled with travoprost. This comparison may determine the real efficacy of the two fixed combinations when added to the prostaglandin. The design of the proposed study should facilitate a better understanding of the role of these medications in glaucoma management.
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
- •Patient has open-angle glaucoma and is older than 29 years
- •Patients should exhibit typical disc, or field changes and an untreated morning IOP greater than 25 mm Hg
- •Patients are treated for at least 3 months with travoprost and should have demonstrated at least a 20% morning IOP reduction
- •Patient deemed by PI to require adjunctive therapy to obtain desired target IOP
- •Patient should exhibit IOP greater than 18 mm Hg on travoprost monotherapy (2 separate IOP readings at 10:00)
- •Patient has mild to moderate glaucoma (field loss more than 16 dB; cupping 0.8 or less)
- •Distance best corrected Snellen visual acuity at least 0.1
- •No contraindications to travoprost, brimonidine, brinzolamide and β-blockers
- •No history of lack of response (<10% morning IOP reduction) to any medication
- •Patient can understand the instructions and adhere to medications
排除标准
- •Female patient of childbearing potential or lactating mother
- •History of trauma, inflammation, surgery
- •History of past use of steroids (within 2 months), severe dry eyes and use of contact lenses
- •Signs of ocular infection, except blepharitis
- •Evidence of corneal abnormality that may affect IOP measurements etc
- •Closed angle
- •History of non-compliance
研究组 & 干预措施
Brinzolamide/Timolol therapy
Chronic therapy for 3 months with brinzolamide/timolol drops given twice daily added to travoprost drops
干预措施: Brimonidine/timolol fixed combination drops added to travoprost (Drug)
Brinzolamide/Timolol therapy
Chronic therapy for 3 months with brinzolamide/timolol drops given twice daily added to travoprost drops
干预措施: Brinzolamide/timolol fixed combination drops added to travoprost (Drug)
Brimonidine/Timolol therapy
Chronic therapy for 3 months with brimonidine/timolol drops given twice daily added to travoprost drops
干预措施: Brimonidine/timolol fixed combination drops added to travoprost (Drug)
Brimonidine/Timolol therapy
Chronic therapy for 3 months with brimonidine/timolol drops given twice daily added to travoprost drops
干预措施: Brinzolamide/timolol fixed combination drops added to travoprost (Drug)
结局指标
主要结局
Mean 24-hour intraocular pressure
时间窗: 3 months
次要结局
- Fluctuation of 24-hour intraocular pressure(3 months)
研究者
AGP Konstas
Professor in Ophthalmology
Aristotle University Of Thessaloniki