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

Withdrawn

• Conditions: Primary Open Angle Glaucoma; Intraocular Pressure

• Registration Number: NCT00863811
• Lead Sponsor: Sooft Italia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-03-17
• Study First Submitted QC: 2009-03-17
• Study First Posted: 2009-03-18
• Study Start: 2009-04
• Primary Completion: 2009-06
• Study Completion: 2009-07
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-05
• Last Update Posted: 2012-06-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intraocular pressure	Enrollment, 1, 2, 3 months

Secondary Outcome Measures

Name	Time	Method
Intraocular pressure fluctuations during the day	Enrollment, 1, 2, 3 months

Trial Locations

Locations (1)

Ophthalmology Department of the University; 🇮🇹 Bari, Italy