Effects of Forskolin on Intraocular Pressure in Glaucomatous Patients Under Treatment With Either Beta-blockers or Prostaglandins Eye Drops

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Primary Open Angle Glaucoma Intraocular Pressure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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2

POAG patients with IOP under control by prostaglandins eye drops treatment and assuming two tablets per day of the food supplement KRONEK

No interventions assigned to this group

1

POAG patients compensated by the treatment of betablockers eye drops and taking two tablets per day of KRONEK

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No