Preservative-free Tafluprost Eye Drops in Newly Diagnosed Patients With Glaucoma: A Prospective Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Intraocular pressure (IOP)
研究概览
简要总结
Glaucoma encompasses a collective group of optic neuropathies characterized by progressive degeneration of retinal ganglion cells and their axons, resulting in cupping, a distinctive appearance of the optic disc, and a pattern of visual loss
详细描述
Saflutan® is the first preservative-free prostaglandin analog introduced to the Egyptian market. It contains the PG analog tafluprost. Better tolerability, higher adherence to treatment and improvement of patients' quality of life are associated with using preservative-free eye drops.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult males and females, newly diagnosed with glaucoma, naïve to glaucoma medications and surgery, able to read, comprehend, and complete the Ocular Surface Disease Index (OSDI) questionnaire, and able to provide informed consent form.
排除标准
- •Unable to provide informed consent form
研究组 & 干预措施
Preservative-free tafluprost
This was an open-label, non-randomized clinical study that aimed to assess the ocular signs and symptoms in 60 eyes of 30 newly diagnosed Egyptian glaucoma patients receiving preservative-free tafluprost eye drops
干预措施: Preservative-free tafluprost eye drops (Drug)
结局指标
主要结局
Intraocular pressure (IOP)
时间窗: 12 weeks
Intraocular pressure (IOP)
次要结局
未报告次要终点
研究者
Amir abou Samra
Prof.
Alexandria University