Clinical trial NCT00864578: Effects of Forskolin on Intraocular Pressure in Glaucomatous Patients Under Maximum Tolerated Medical Therapy
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)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Primary Open Angle Glaucoma
Intraocular Pressure
Keywords: POAG
IOP
Forskolin
Food supplement
Lead sponsor: Sooft Italia
Sponsor class: INDUSTRY
First posted: 2009-03-18
Enrollment: 0
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients affected by POAG and already under observation in the centers that take part in this study

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 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.


Eligibility 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

Primary outcomes:
measure: Intraocular pressure
timeFrame: Enrollment, 1, 2, 3, 4 weeks after initiation of treatment
Secondary outcomes:
measure: Intraocular pressure fluctuations during the day
timeFrame: Enrollment, 1, 2, 3, 4 weeks after initiation of treatment
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Ophthalmology Department of the University Clinic
Study officials:
affiliation: Ophthalmology Dpt., University of Bari, Italy
name: Michele Vetrugno, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Daly JW. Forskolin, adenylate cyclase, and cell physiology: an overview. Adv Cyclic Nucleotide Protein Phosphorylation Res. 1984;17:81-9.
citation: 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.
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. doi: 10.1001/archopht.1987.01060020103038.