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临床试验/NCT00863811
NCT00863811撤回不适用

Effects of the Oral Administration of an Association of Forskolin With Rutin and Vitamins B on Intraocular Pressure in Patients Affected by Primary Open Angle Glaucoma and Treated With Either Beta-blockers or Prostaglandin Eye Drops

Sooft Italia1 个研究点 分布在 1 个国家开始时间: 2009年4月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
Intraocular pressure

研究概览

简要总结

Elevated intraocular pressure is still the main risk factor for development and progression of glaucoma. Several drugs exist on the market that may decrease IOP in glaucomatous patients. However, some patients cannot reach the target pressure despite a multitherapy with a combination of drugs, and are therefore addressed to surgical treatments. Forskolin is a natural compound that is a receptor-independent adenyl-cyclase activator, that increases intracellular cAMP. It has been shown to be able to decrease IOP after topical application, by a mechanism that is not used by the other drugs. Aim of the present study is to see whether oral administration of a food supplement containing forskolin (KRONEK) has any effect on the IOP of POAG patients with stable IOP obtained by treatment with either beta-blockers or prostaglandins.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
30 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Primary Open Angle Glaucoma associated with ocular hypertension
  • Target pressure achieved by single-agent therapy (beta-blockers or prostaglandins)
  • Visual acuity > 6/10

排除标准

  • Miopy or Hypermetropy > 5D
  • Concomitant ocular pathologies
  • Previous ocular surgery
  • Known hypersensitivity to any of the components in the KRONEK tablets
  • Concomitant participation in other trials
  • Changes of topic glaucoma therapy during the course of the study

结局指标

主要结局

Intraocular pressure

时间窗: Enrollment, 1, 2, 3 months

次要结局

  • Intraocular pressure fluctuations during the day(Enrollment, 1, 2, 3 months)

研究者

发起方
Sooft Italia
申办方类型
Industry

研究点 (1)

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