An Open, Non-randomized Pilot Study on the Effect of Preservative Free Tafluprost (Saflutan® Augentropfen) in Patients With Ocular Hypertension or Primary Open Angle Glaucoma With an Uncontrolled Intraocular Pressure of 30 mmHg and More
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Intraocular pressure
研究概览
简要总结
Increased intraocular pressure (IOP) has been identified as the most important risk factor for the development and the progression of glaucoma. Data from large interventional studies have shown that a decrease of IOP is associated with a reduced risk of progression of the disease. This underlines the importance of a potent and save IOP lowering therapy. The introduction of preservative free tafluprost offers a new treatment possibility using a potent topical prostaglandin analogue without the disadvantages of a co-administered preservative. The current study seeks to investigate the effect of an 8 week therapy with preservative free tafluprost on intraocular pressure in patients with ocular hypertension or primary open angle glaucoma having an IOP of 30 mmHg or more.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged over 18 years
- •Diagnosed primary open angle glaucoma and an IOP of 30mmHg or more in at least 1 eye at visit 1 at 8 am
- •Patients with ocular hypertension as defined as an IOP of 30mmHg or more and normal findings in the visual field and the optic nerve head
排除标准
- •Participation in a clinical trial in the 3 weeks before the screening visit
- •Severe visual field loss as defined as an MD of -15 or worse
- •Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- •Presence or history of a severe medical condition that will interfere with the study aim as judged by the clinical investigator
- •Presence or history of a severe ocular condition that will interfere with the study aim as judged by the clinical investigator
- •Wearing of contact lenses
- •Topical treatment with any ophthalmic drug in the 4 weeks preceding the study except glaucoma medication or topical lubricants
- •Ocular infection
- •Ocular surgery in the 6 months preceding the study
- •Pregnancy, planned pregnancy or lactating
- •Contraindication against the use of topical prostaglandin therapy
研究组 & 干预措施
Patients with POAG or OHT
Patients with primary open angle glaucoma or ocular hypertension
干预措施: Saflutan® 15 microgram/ml Augentropfen im Einzeldosisbehältnis (Drug)
结局指标
主要结局
Intraocular pressure
时间窗: 8 weeks
Intraocular pressure will be measured at baseline, after 4 weeks and after 8 weeks at 8:00 am and 6:00 pm on each study day
次要结局
未报告次要终点
研究者
Dr. Anton Hommer
Dr. med. univ.
Ordination Dr. Hommer