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

This study has been withdrawn prior to enrollment.
(loss of interest before enrolment started)
Sponsor:
Information provided by:
Sooft Italia
ClinicalTrials.gov Identifier:
NCT00864578
First received: March 17, 2009
Last updated: June 5, 2012
Last verified: June 2012
  Purpose

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.


Condition
Primary Open Angle Glaucoma
Intraocular Pressure

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effects of the Oral Administration of an Association of Forskolin With Rutin and Vitamins B on Intraocular Pressure (IOP) in Patients Affected by Primary Open Angle Glaucoma (POAG) Under Maximun Tolerated Medical Therapy (MTMT)

Resource links provided by NLM:


Further study details as provided by Sooft Italia:

Primary Outcome Measures:
  • Intraocular pressure [ Time Frame: Enrollment, 1, 2, 3, 4 weeks after initiation of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intraocular pressure fluctuations during the day [ Time Frame: Enrollment, 1, 2, 3, 4 weeks after initiation of treatment ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: April 2009
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients affected by POAG and already under observation in the centers that take part in this study

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00864578

Locations
Italy
Ophthalmology Department of the University Clinic
Bari, Italy, I-70124
Sponsors and Collaborators
Sooft Italia
Investigators
Principal Investigator: Michele Vetrugno, MD Ophthalmology Dpt., University of Bari, Italy
  More Information

Additional Information:
Publications:
Responsible Party: Prof. MICHELE VETRUGNO, OPHTHALMOLOGY DPT, UNIVERSITY OF BARI (ITALY)
ClinicalTrials.gov Identifier: NCT00864578     History of Changes
Other Study ID Numbers: KRONEK-MTMT, KRONEK-001
Study First Received: March 17, 2009
Last Updated: June 5, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Sooft Italia:
POAG
IOP
Forskolin
Food supplement

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on September 30, 2014