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 in Patients Affected by Primary Open Angle Glaucoma and Treated With Either Beta-blockers or Prostaglandin Eye Drops
| 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 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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | July 2009 |
| Est. primary completion date | June 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 30 Years to 70 Years |
| Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Italy | Ophthalmology Department of the University | 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
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Intraocular pressure | Enrollment, 1, 2, 3 months | No | |
| Secondary | Intraocular pressure fluctuations during the day | Enrollment, 1, 2, 3 months | No |
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