- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00864578
Effects of Forskolin on Intraocular Pressure in Glaucomatous Patients Under Maximum Tolerated Medical Therapy
June 5, 2012 updated by: Sooft Italia
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)
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.
Study Overview
Status
Withdrawn
Conditions
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bari, Italy, I-70124
- Ophthalmology Department of the University Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients affected by POAG and already under observation in the centers that take part in this study
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Intraocular pressure
Time Frame: Enrollment, 1, 2, 3, 4 weeks after initiation of treatment
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Enrollment, 1, 2, 3, 4 weeks after initiation of treatment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Intraocular pressure fluctuations during the day
Time Frame: Enrollment, 1, 2, 3, 4 weeks after initiation of treatment
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Enrollment, 1, 2, 3, 4 weeks after initiation of treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michele Vetrugno, MD, Ophthalmology Dpt., University of Bari, Italy
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Caprioli J, Sears M. The adenylate cyclase receptor complex and aqueous humor formation. Yale J Biol Med. 1984 May-Jun;57(3):283-300.
- Daly JW. Forskolin, adenylate cyclase, and cell physiology: an overview. Adv Cyclic Nucleotide Protein Phosphorylation Res. 1984;17:81-9.
- Caprioli J, Sears M. Forskolin lowers intraocular pressure in rabbits, monkeys, and man. Lancet. 1983 Apr 30;1(8331):958-60. doi: 10.1016/s0140-6736(83)92084-6.
- Lee PY, Podos SM, Serle JB, Camras CB, Severin CH. Intraocular pressure effects of multiple doses of drugs applied to glaucomatous monkey eyes. Arch Ophthalmol. 1987 Feb;105(2):249-52. doi: 10.1001/archopht.1987.01060020103038.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (ANTICIPATED)
June 1, 2009
Study Completion (ANTICIPATED)
June 1, 2009
Study Registration Dates
First Submitted
March 17, 2009
First Submitted That Met QC Criteria
March 17, 2009
First Posted (ESTIMATE)
March 18, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
June 6, 2012
Last Update Submitted That Met QC Criteria
June 5, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KRONEK-MTMT
- KRONEK-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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