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

Sooft Italia

Status: Withdrawn

Conditions: Primary Open Angle Glaucoma; Intraocular Pressure

Study type: Observational

Funder types: Industry

Identifiers

NCT00863811

KRONEK-PG-BB

Details and patient eligibility

About

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.

Sex: All

Ages: 30 to 70 years old

Volunteers: No 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

Trial design

0 participants in 2 patient groups

2

Description:

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

1

Description:

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