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

NCT ID: NCT00864578

Last Updated: 2012-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-06-30

Brief Summary

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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

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Conditions

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Primary Open Angle Glaucoma Intraocular Pressure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sooft Italia

INDUSTRY

Sponsor Role lead

Responsible Party

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OPHTHALMOLOGY DPT, UNIVERSITY OF BARI (ITALY)

Principal Investigators

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Michele Vetrugno, MD

Role: PRINCIPAL_INVESTIGATOR

Ophthalmology Dpt., University of Bari, Italy

Locations

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Ophthalmology Department of the University Clinic

Bari, , Italy

Site Status

Countries

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Italy

References

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Caprioli J, Sears M. The adenylate cyclase receptor complex and aqueous humor formation. Yale J Biol Med. 1984 May-Jun;57(3):283-300.

Reference Type BACKGROUND
PMID: 6093393 (View on PubMed)

Daly JW. Forskolin, adenylate cyclase, and cell physiology: an overview. Adv Cyclic Nucleotide Protein Phosphorylation Res. 1984;17:81-9.

Reference Type BACKGROUND
PMID: 6328947 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6132271 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3813959 (View on PubMed)

Other Identifiers

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KRONEK-001

Identifier Type: -

Identifier Source: secondary_id

KRONEK-MTMT

Identifier Type: -

Identifier Source: org_study_id

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