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

NCT00864578 | Withdrawn DMC

• 2 other identifiers: KRONEK-MTMTKRONEK-001
• 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 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.

Conditions

Primary Open Angle Glaucoma; Intraocular Pressure

Keywords

POAG; IOP; Forskolin; Food supplement

Outcome Measures

Primary Outcomes (1)

• Intraocular pressure

  Enrollment, 1, 2, 3, 4 weeks after initiation of treatment

Secondary Outcomes (1)

• Intraocular pressure fluctuations during the day

  Enrollment, 1, 2, 3, 4 weeks after initiation of treatment

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:

• Age: 30-70 Years
• Sex: both
• Pathology: POAG
• Characteristics: Target pressure not achieved with current treatments

You may not qualify if:

• Concomitant ocular pathologies
• Previous ocular surgery
• Known hypersensitivity to any of the components in the KRONEK tablets
• Concomitant participation in other trials

Sponsors & Collaborators

• Sooft Italia: lead

Study Sites (1)

Ophthalmology Department of the University Clinic

Bari, I-70124, Italy

Location

Related Publications (4)

• 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

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

  PMID: 6328947 BACKGROUND

• 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

• 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.

  PMID: 3813959 BACKGROUND

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Officials

• Michele Vetrugno, MD

  Ophthalmology Dpt., University of Bari, Italy

  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: June 1, 2009
• Last Updated: June 6, 2012

Record last verified: 2012-06

Locations

IT (1)