24-hour Efficacy and Ocular Surface Health With PF Tafluprost and Combined Therapy With PF Tafluprost and Dorzolamide/Timolol Fixed Combination in Open-angle Glaucoma Subjects Insufficiently Controlled With Latanoprost
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 43
- 主要终点
- Mean 24-hour efficacy (average intraocular pressure readings over 24 hours)
研究概览
简要总结
The study investigated the 24-hour efficacy and ocular surface health with preservative-free tafluprost and a combined preservative-free regimen (tafluprost and dorzolamide/timolol fixed combination) in open-angle glaucoma patients insufficiently controlled on latanoprost monotherapy and showing signs, or symptoms of ocular surface disease with preservative-containing latanoprost monotherapy. This trial randomized open-angle glaucoma patients insufficiently controlled (IOP > 20 mm Hg) on branded, or generic latanoprost monotherapy who required further IOP reduction and who demonstrated clinical signs, or symptoms of ocular surface disease.
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
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Tafluprost drops
Treatment with preservative-free talfuprost drops administered once in the evening. Evaluation of 24-hour efficacy and ocular surface health after 3 months of therapy.
干预措施: tafluprost (Drug)
Tafluprost and dorzolamide/timolol drops
Concomitant therapy with preservative-free talfuprost drops administered once in the evening and dorzolamide/timolol fixed combination drops given twice daily. Evaluation of 24-hour efficacy and ocular surface health after 3 months of therapy.
干预措施: tafluprost and dorzolamide/timolol (Drug)
结局指标
主要结局
Mean 24-hour efficacy (average intraocular pressure readings over 24 hours)
时间窗: 3 months
次要结局
- Mean 24-hour peak intraocular pressure(3 months)
- Mean 24-hour fluctuation of intraocular pressure(3 months)
- Break-up time of tear film(3 months)
- Corneal staining(3 months)
研究者
AGP Konstas
Professor AGP Konstas
Aristotle University Of Thessaloniki