Effect of Alphagan and Xalatan Eye Drops on Corneal Temperature
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Corneal temperature
研究概览
简要总结
It is already known that the local treatment with Alphagan eye drops (a drug commonly used by glaucoma patients) reduces ocular blood flow. In-vitro studies suggest that the vasoconstrictive effect of Alphagan is more pronounced when this drug is combined with a prostaglandin analogue (eg. Xalatan eye drops). The investigators also question whether this effect is more pronounced in subjects suffering from a primary vascular dysregulation (PVD). To test for the effect of these drugs on PVD and non-PVD subjects the investigators will take measurements of corneal temperature as surrogate for ocular blood flow.
详细描述
The investigators would like to investigate the effect of Alphagan eye drops, Xalatan eye drops and their combination (both Alphagan and Xalatan) on corneal temperature in healthy subjects with and without a primary vascular dysregulation (PVD).
The investigators would like to answer the following questions:
- Do the individual drugs influence the circulation to the eye as quantified indirectly via corneal temperature?
- Does the combination of Alphagan and Xalatan give an additive or even potentiated effect?
- Is the sequence of application of drugs of relevance (Alphagan applied first, Xalatan second, or vice versa)?
- Do PVD and non-PVD subjects respond differently to these drugs?
20 healthy non-PVD subjects and 20 healthy PVD subjects in the age range from 20-40 years will be recruited. Recruited subjects will have all measurements: corneal temperature, intraocular pressure (IOP), ear temperature, blood-pressure. Both prior to and after instillation of eye drops (Xalatan, Alphagan and placebo).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 48 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 18-48 years
- •normal findings on ophthalmological examination
排除标准
- •history of ocular or systemic disease
- •chronic or current systemic or topical medication
- •drug or alcohol abuse
- •art. hypertension
研究组 & 干预措施
healthy subjects without PVD
healthy subjects without primary vascular dysregulation Intervention: Brimonidine, Latanoprost and Placebo
干预措施: Brimonidine (Drug)
healthy subjects without PVD
healthy subjects without primary vascular dysregulation Intervention: Brimonidine, Latanoprost and Placebo
干预措施: Latanoprost (Drug)
healthy subjects without PVD
healthy subjects without primary vascular dysregulation Intervention: Brimonidine, Latanoprost and Placebo
干预措施: Placebo (Drug)
healthy subjects with PVD
healthy subjects with primary vascular dysregulation Intervention: Brimonidine, Latanoprost and Placebo
干预措施: Brimonidine (Drug)
healthy subjects with PVD
healthy subjects with primary vascular dysregulation Intervention: Brimonidine, Latanoprost and Placebo
干预措施: Latanoprost (Drug)
healthy subjects with PVD
healthy subjects with primary vascular dysregulation Intervention: Brimonidine, Latanoprost and Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Corneal temperature
时间窗: Week 1: day 1 and 2 before eyedrops and after. Week 2: day 1 and 2 before eyedrops and after.
次要结局
- Blood pressure(Week 1: day 1 and 2 before eyedrops and after. Week 2: day 1 and 2 before eyedrops and after.)
- Intraocular pressure(Week 1: day 1 and 2 before eyedrops and after. Week 2: day 1 and 2 before eyedrops and after.)
- Ear temperature(Week 1: day 1 and 2 before eyedrops and after. Week 2: day 1 and 2 before eyedrops and after.)