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

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00863811

Enrollment

Registered

2009-03-18

Start date

2009-04-30

Completion date

2009-07-31

Last updated

2012-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraocular Pressure, Primary Open Angle Glaucoma

Keywords

POAG, IOP, Forskolin, beta-blockers, prostaglandins

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

30 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Intraocular pressure	Enrollment, 1, 2, 3 months

Secondary

Measure	Time frame
Intraocular pressure fluctuations during the day	Enrollment, 1, 2, 3 months

Countries

Italy

Outcome results