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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00863811
Recruitment Status : Withdrawn (loss of interest before enrolment started)
First Posted : March 18, 2009
Last Update Posted : June 6, 2012
Sponsor:
Information provided by:
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.

Condition or disease
Primary Open Angle Glaucoma Intraocular Pressure

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Study Type : Observational
Actual Enrollment : 0 participants
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 in Patients Affected by Primary Open Angle Glaucoma and Treated With Either Beta-blockers or Prostaglandin Eye Drops
Study Start Date : April 2009
Estimated Primary Completion Date : June 2009
Estimated Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Group/Cohort
2
POAG patients with IOP under control by prostaglandins eye drops treatment and assuming two tablets per day of the food supplement KRONEK
1
POAG patients compensated by the treatment of betablockers eye drops and taking two tablets per day of KRONEK



Primary Outcome Measures :
  1. Intraocular pressure [ Time Frame: Enrollment, 1, 2, 3 months ]

Secondary Outcome Measures :
  1. Intraocular pressure fluctuations during the day [ Time Frame: Enrollment, 1, 2, 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00863811


Locations
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Italy
Ophthalmology Department of the University
Bari, Italy, I-70124
Sponsors and Collaborators
Sooft Italia
Investigators
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Principal Investigator: Michele Vetrugno, MD Ophthalmology Department, University of Bari
Additional Information:
Publications:
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Responsible Party: Michele Vetrugno, Ophthalmology Dept., University of Bari, Italy
ClinicalTrials.gov Identifier: NCT00863811    
Other Study ID Numbers: KRONEK-PG-BB
First Posted: March 18, 2009    Key Record Dates
Last Update Posted: June 6, 2012
Last Verified: June 2012
Keywords provided by Sooft Italia:
POAG
IOP
Forskolin
beta-blockers
prostaglandins
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases