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临床试验/NCT00712400
NCT00712400已完成不适用

Effects of Latanoprost on Choroidal Blood Flow Regulation in Human Subjects

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2005年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
Choroidal pressure-flow relationship

研究概览

简要总结

Latanoprost is a synthetic prodrug of 17-phenyl-substituted prostaglandin F2α analog. Used at a dose of one drop per day, it has been reported to produce a 30 to 35% reduction in intraocular pressure. Its mechanism of activation involves augmentation of the eye's natural uveoscleral outflow capacity .

There is evidence that ocular blood flow plays a role in the clinical course of glaucoma. Glaucoma medication that lowers IOP simultaneously increases ocular blood perfusion pressure, which in turn may increase ocular blood flow.

This could well contribute to the partially contradicting results concerning ocular hemodynamic effects of latanoprost. In vitro studies indicate that latanoprost has no effect on ocular vascular tone in therapeutical doses. By contrast, it has been reported in several studies that latanoprost 0.005% increases pulsatile ocular blood flow in patients with primary open angle glaucoma and normal tension glaucoma. This increase in pulsatile ocular blood flow mainly reflects an increase in the choroidal circulation.

Little is known about the potential effect of latanoprost on choroidal blood flow regulation in humans. The present study therefore tries to elucidate whether treatment with latanoprost may alter choroidal blood flow regulation during artificial changes in ocular perfusion pressure. In addition, the present study aims to clarify whether the change in choroidal blood flow after latanoprost administration are due to direct vasoactive effects or due to the increase in ocular perfusion pressure. The second alternative may have important implications on our understanding of glaucoma treatment, because reduction of IOP may then per se result in normalization of ocular blood flow regulation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Double (Participant, Investigator)

入排标准

年龄范围
19 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Men aged between 19 and 35 years, nonsmokers
  • Body mass index between 15th and 85th percentile (Must et al. 1991)
  • Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
  • Normal ophthalmic findings, ametropia < 3 dpt.

排除标准

  • Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
  • Treatment in the previous 3 weeks with any drug
  • Symptoms of a clinically relevant illness in the 3 weeks before the first study day
  • History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs
  • Blood donation during the previous 3 weeks
  • Ametropia >= 3 dpt
  • Iris bicolor

研究组 & 干预措施

1

Active Comparator

Latanoprost 0.005%, Xalatan®

干预措施: Latanoprost 0.005%, Xalatan® (Drug)

2

Placebo Comparator

Vehicle to latanoprost (eyedrops containing the same stabilizers as latanoprost, but no active drug)

干预措施: Placebo (Drug)

结局指标

主要结局

Choroidal pressure-flow relationship

时间窗: in total 4 hours

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gerhard Garhofer

Assoc. Prof. PD Dr.

Medical University of Vienna

研究点 (1)

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