MedPath

Effects of Forskolin on Intraocular Pressure in Glaucomatous Patients Under Maximum Tolerated Medical Therapy

Withdrawn
Conditions
Primary Open Angle Glaucoma
Intraocular Pressure
Registration Number
NCT00864578
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 a food supplement containing forskolin (KRONEK) has any effect on the IOP of POAG patients that cannot reach their target pressure, and are therefore on the waiting list for surgical intervention.

Detailed Description

Not available

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
Inclusion Criteria
  • Age: 30-70 Years
  • Sex: both
  • Pathology: POAG
  • Characteristics: Target pressure not achieved with current treatments
Exclusion Criteria
  • Concomitant ocular pathologies
  • Previous ocular surgery
  • Known hypersensitivity to any of the components in the KRONEK tablets
  • Concomitant participation in other trials

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Intraocular pressureEnrollment, 1, 2, 3, 4 weeks after initiation of treatment
Secondary Outcome Measures
NameTimeMethod
Intraocular pressure fluctuations during the dayEnrollment, 1, 2, 3, 4 weeks after initiation of treatment

Trial Locations

Locations (1)

Ophthalmology Department of the University Clinic

🇮🇹

Bari, Italy

© Copyright 2025. All Rights Reserved by MedPath