Clinical trial NCT00863811: Effects of Forskolin on Intraocular Pressure in Glaucomatous Patients Under Treatment With Either Beta-blockers or Prostaglandins Eye Drops
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 type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Primary Open Angle Glaucoma
Intraocular Pressure
Keywords: POAG
IOP
Forskolin
beta-blockers
prostaglandins
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 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.


Eligibility 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

Primary outcomes:
measure: Intraocular pressure
timeFrame: Enrollment, 1, 2, 3 months
Secondary outcomes:
measure: Intraocular pressure fluctuations during the day
timeFrame: Enrollment, 1, 2, 3 months
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Ophthalmology Department of the University
Study officials:
affiliation: Ophthalmology Department, University of Bari
name: Michele Vetrugno, MD
role: PRINCIPAL_INVESTIGATOR
References:
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: 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: Lee PY, Podos SM, Howard-Williams JR, Severin CH, Rose AD, Siegel MJ. Pharmacological testing in the laser-induced monkey glaucoma model. Curr Eye Res. 1985 Jul;4(7):775-81. doi: 10.3109/02713688509020033.