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
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
- 否
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)
