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)
| Verified date | June 2012 |
| Source | Sooft Italia |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Italy: Ethics Committee |
| Study type | Observational |
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.
| Status | Withdrawn |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 |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Italy | Ophthalmology Department of the University Clinic | Bari |
| Lead Sponsor | Collaborator |
|---|---|
| Sooft Italia |
Italy,
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
| 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 |
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