Effects of Forskolin on Intraocular Pressure in Glaucomatous Patients Under Treatment With Either Beta-blockers or Prostaglandins Eye Drops

NCT00863811 | Withdrawn DMC

• 1 other identifier: KRONEK-PG-BB
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Open Angle Glaucoma; Intraocular Pressure

Keywords

POAG; IOP; Forskolin; beta-blockers; prostaglandins

Outcome Measures

Primary Outcomes (1)

• Intraocular pressure

  Enrollment, 1, 2, 3 months

Secondary Outcomes (1)

• Intraocular pressure fluctuations during the day

  Enrollment, 1, 2, 3 months

Study Arms (2)

2

POAG patients with IOP under control by prostaglandins eye drops treatment and assuming two tablets per day of the food supplement KRONEK

1

POAG patients compensated by the treatment of betablockers eye drops and taking two tablets per day of KRONEK

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients affected by POAG and already under observation in the centers that take part in this study

You may qualify if:

• Primary Open Angle Glaucoma associated with ocular hypertension
• Target pressure achieved by single-agent therapy (beta-blockers or prostaglandins)
• Visual acuity \> 6/10

You may not qualify if:

• 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

Sponsors & Collaborators

• Sooft Italia: lead

Study Sites (1)

Ophthalmology Department of the University

Bari, I-70124, Italy

Location

Related Publications (3)

• 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.

  PMID: 6132271 BACKGROUND

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

  PMID: 6093393 BACKGROUND

• 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.

  PMID: 3861296 BACKGROUND

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Officials

• Michele Vetrugno, MD

  Ophthalmology Department, University of Bari

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 17, 2009
• First Posted: March 18, 2009
• Study Start: April 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: July 1, 2009
• Last Updated: June 6, 2012

Record last verified: 2012-06

Locations

IT (1)