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

Primary Open Angle Glaucoma Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00864578
• Other study ID #: KRONEK-MTMT
• Secondary ID: KRONEK-001
• Status: Withdrawn
• Phase: N/A
• First received: March 17, 2009
• Last updated: June 5, 2012
• Start date: April 2009
• Est. completion date: June 2009

Study information

• Verified date: June 2012
• Source: Sooft Italia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Intraocular Pressure
• Primary Open Angle Glaucoma

Locations

Country	Name	City	State
Italy	Ophthalmology Department of the University Clinic	Bari

Sponsors (1)

Lead Sponsor	Collaborator
Sooft Italia

Country where clinical trial is conducted

Italy, 

References & Publications (4)

Caprioli J, Sears M. Forskolin lowers intraocular pressure in rabbits, monkeys, and man. Lancet. 1983 Apr 30;1(8331):958-60. — View Citation

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

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular pressure		Enrollment, 1, 2, 3, 4 weeks after initiation of treatment	No
Secondary	Intraocular pressure fluctuations during the day		Enrollment, 1, 2, 3, 4 weeks after initiation of treatment	No

External Links

•   homepage of the food supplement KRONEK