Primary Open Angle GlaucomaNCT00863811
Effects of Forskolin on Intraocular Pressure in Glaucomatous Patients Under Treatment With Either Beta-blockers or Prostaglandins Eye Drops
An observational study of Primary Open Angle Glaucoma and Intraocular Pressure, run by Sooft Italia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Primary Open Angle Glaucoma, Intraocular Pressure
- Type of treatment
- Pill or oral medicine
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2009to Jul 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients affected by POAG and already under observation in the centers that take part in this study
Who may be able to join
- Primary Open Angle Glaucoma associated with ocular hypertension
- Target pressure achieved by single-agent therapy (beta-blockers or prostaglandins)
- Visual acuity > 6/10
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure
Measured: Enrollment, 1, 2, 3 months
Secondary outcomes (1)
Intraocular pressure fluctuations during the day
Measured: Enrollment, 1, 2, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionJun 2009 (estimated)
- Study completionJul 2009 (estimated)
Why it stopped: loss of interest before enrolment started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Primary Open Angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sooft Italia
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michele Vetrugno, MD, Principal investigator, Ophthalmology Department, University of Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00863811
- Sponsor's protocol ID
- KRONEK-PG-BB
- Status last verified
- Jun 2012
- First submitted
- 17 Mar 2009
- Last updated
- 6 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 6132271Caprioli J, Sears M. The adenylate cyclase receptor complex and aqueous humor formation. Yale J Biol Med. 1984 May-Jun;57(3):283-300.
PubMed 6093393Lee 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.
PubMed 3861296
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00863811
- Acronym / sponsor ID
- KRONEK-PG-BB
- Conditions
- Primary Open Angle Glaucoma, Intraocular Pressure
- Keywords
- POAG, IOP, Forskolin, beta-blockers, prostaglandins
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: loss of interest before enrolment started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sooft ItaliaIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Jul 2009 (estimated)
- First posted
- 18 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by POAG and already under observation in the centers that take part in this study
Key inclusion criteria (3 listed)
- Primary Open Angle Glaucoma associated with ocular hypertension
- Target pressure achieved by single-agent therapy (beta-blockers or prostaglandins)
- Visual acuity > 6/10
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intraocular pressure
Time frame: Enrollment, 1, 2, 3 months
1 secondary outcome
Intraocular pressure fluctuations during the day
Time frame: Enrollment, 1, 2, 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2012.
- Background: PubMed 6132271Caprioli 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.
- Background: PubMed 6093393Caprioli J, Sears M. The adenylate cyclase receptor complex and aqueous humor formation. Yale J Biol Med. 1984 May-Jun;57(3):283-300.
- Background: PubMed 3861296Lee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele Vetrugno, MD principal investigator
Ophthalmology Department, University of Bari
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Open Angle Glaucoma and Intraocular Pressure, run by Sooft Italia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure (time frame: Enrollment, 1, 2, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00863811, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2012.