Effects of Forskolin on Intraocular Pressure in Glaucomat... | NCT00863811

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

NCT00863811

Sponsor

Sooft Italia

Status

Withdrawn

Last Update Posted

Jun 6, 2012Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Primary Open Angle Glaucoma
Intraocular Pressure

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

loss of interest before enrolment started

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Jun 2009Estimated

Completion Date

Jul 2009Estimated

First Submitted Date

Mar 17, 2009

First Submission Date that Met QC Criteria

Mar 17, 2009

First Posted Date

Mar 18, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 5, 2012

Last Update Posted Date

Jun 6, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intraocular pressure		Enrollment, 1, 2, 3 months

Secondary Outcomes

Measure	Description	Time Frame
Intraocular pressure fluctuations during the day		Enrollment, 1, 2, 3 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michele Vetrugno, MD	Ophthalmology Department, University of Bari	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ophthalmology Department of the University		Bari		I-70124	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
6132271	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.
6093393	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.

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension
D005128	Eye Diseases