Ocular PhysiologyPhase 4NCT00312416
Effects of Topical Clonidine vs. Brimonidine on Choroidal Blood Flow and Intraocular Pressure During Isometric Exercise
A Phase 4 study testing Clonidin and Brimonidine in people with Ocular Physiology and Regional Blood Flow, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Brimonidine tartrate is an alpha-2 agonist ocular hypotensive drug that exerts its effect by causing both a decrease in aqueous production and an increase in uveoscleral outflow. It has been proven to reduce increased intraocular pressure in glaucoma and ocular hypertension. Read more about this study
- Who is it for?
- Ages 19 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Ocular Physiology, Regional Blood Flow
- What is being tested?
- Clonidin and Brimonidine
- How many people
- 18 participants
- Where
- 1 siteAustria
- Study dates
- Feb 2004to Dec 2004
- Phase
- Phase 4
- 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 19 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men aged between 19 and 35 years, nonsmokers
- Body mass index between 15th and 85th percentile (Must A et al. 1991)
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- Normal ophthalmic findings, ametropy < 3 Dpt.
- Intraocular pressure between 10 and 18 mmHg.
Who cannot join
- Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
- Treatment in the previous 3 weeks with any drug
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- History of hypersensitivity to the trial drug or to drugs with a similar chemical structure
- History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with, distribution, metabolism or excretion of study drugs
- Blood donation during the previous 3 weeks
- History or family history of epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
Brimonidine tartrate is an alpha-2 agonist ocular hypotensive drug that exerts its effect by causing both a decrease in aqueous production and an increase in uveoscleral outflow. It has been proven to reduce increased intraocular pressure in glaucoma and ocular hypertension. As an alpha 2 agonist Brimonidine belongs to the same class of drugs as Clonidine; however, its molecular structure is sufficiently different to make it more selective for the alpha 2 receptor than Clonidine. Unlike Clonidine, Brimonidine does not appear to have an effect on the central nervous system and therefore does not cause sedation or systemic hypotension.
In addition to their known effect of lowering intraocular pressure, alpha 2 adrenoceptor agonists are neuroprotective. It has, however, been shown that Brimonidine is a very potent vasoconstrictor in the ciliary body thus reducing aqueous humor production. Little is, however, known about potential vasoconstrictor effects of Brimonidine in the posterior pole of the eye. This is of clinical importance, because optic nerve head ischemia appears to contribute to glaucoma pathophysiology.
This study is performed to investigate the effects of topical Clonidine vs. topical Brimonidine on choroidal blood flow and intraocular pressure during isometric exercise.
- Conditions
- Ocular Physiology, Regional Blood Flow
- Being tested
- Clonidin, Brimonidine
- Keywords
- Choroidal blood flow, Clonidin, Brimonidin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClonidinDrug
BrimonidineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Choroidal pressure-flow relationship
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2006 (estimated)
- Study startFeb 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular PhysiologyStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 18 participants
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Gabriele Fuchsjäger-Mayrl, M.D., Principal investigator, Deapartment of Clinical Pharmacology, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00312416
- Sponsor's protocol ID
- OPHT-121203B
- Status last verified
- Feb 2007
- First submitted
- 6 Apr 2006
- Last updated
- 12 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Topical Clonidine vs. Brimonidine on Choroidal Blood Flow and Intraocular Pressure During Isometric Exercise
- ClinicalTrials.gov ID
- NCT00312416
- Acronym / sponsor ID
- OPHT-121203B
- Conditions
- Ocular Physiology, Regional Blood Flow
- Keywords
- Choroidal blood flow, Clonidin, Brimonidin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Feb 2004
- Study completion
- Dec 2004
- First posted
- 10 Apr 2006 (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.
Brimonidine tartrate is an alpha-2 agonist ocular hypotensive drug that exerts its effect by causing both a decrease in aqueous production and an increase in uveoscleral outflow. It has been proven to reduce increased intraocular pressure in glaucoma and ocular hypertension. As an alpha 2 agonist Brimonidine belongs to the same class of drugs as Clonidine; however, its molecular structure is sufficiently different to make it more selective for the alpha 2 receptor than Clonidine. Unlike Clonidine, Brimonidine does not appear to have an effect on the central nervous system and therefore does not cause sedation or systemic hypotension.
In addition to their known effect of lowering intraocular pressure, alpha 2 adrenoceptor agonists are neuroprotective. It has, however, been shown that Brimonidine is a very potent vasoconstrictor in the ciliary body thus reducing aqueous humor production. Little is, however, known about potential vasoconstrictor effects of Brimonidine in the posterior pole of the eye. This is of clinical importance, because optic nerve head ischemia appears to contribute to glaucoma pathophysiology.
This study is performed to investigate the effects of topical Clonidine vs. topical Brimonidine on choroidal blood flow and intraocular pressure during isometric exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Men aged between 19 and 35 years, nonsmokers
- Body mass index between 15th and 85th percentile (Must A et al. 1991)
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- Normal ophthalmic findings, ametropy < 3 Dpt.
- Intraocular pressure between 10 and 18 mmHg.
Key exclusion criteria (7 listed)
- Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
- Treatment in the previous 3 weeks with any drug
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- History of hypersensitivity to the trial drug or to drugs with a similar chemical structure
- History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with, distribution, metabolism or excretion of study drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clonidin | Drug | – |
| Brimonidine | Drug | – |
Primary outcome
Choroidal pressure-flow relationship
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2007.
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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.
Gabriele Fuchsjäger-Mayrl, M.D. principal investigator
Deapartment of Clinical Pharmacology, Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clonidin and Brimonidine in people with Ocular Physiology and Regional Blood Flow, run by Medical University of Vienna at 1 site in Austria.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 12 Feb 2007. 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 Austria. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Choroidal pressure-flow relationship. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2007.