Ocular PhysiologyNCT00712777
Relation Between Intraocular Pressure Lowering Effects of Topical Brimonidine and Alpha 2 Receptor Polymorphism
A study testing Brimonidine 0.2 % in people with Ocular Physiology and Intraocular Pressure, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Topical brimonidine is a recently introduced alpha 2 receptor agonist which is used in the therapy of intraocular pressure (IOP) reduction in patients with open angle glaucoma. Although adequate IOP reduction is achieved in many patients there is a considerable degree of variability in IOP reduction among subjects. 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, Intraocular Pressure
- What is being tested?
- Brimonidine 0.2 %
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteAustria
- Study dates
- Mar 2008to Nov 2014
- Phase
- Interventional
- 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
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- IOP between 12 and 16 mmHg
- Normal ophthalmic findings, ametropia < 3 Dpt.
- Results of alpha-2B receptor genotyping; subjects who fall within one of the following groups: group 1: homozygote mutant: I/I (n=40); group 2: homozygote mutant: D/D (n=40)
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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Clinical Pharmacology
Vienna, State of Vienna, 1090
About this study
Topical brimonidine is a recently introduced alpha 2 receptor agonist which is used in the therapy of intraocular pressure (IOP) reduction in patients with open angle glaucoma. Although adequate IOP reduction is achieved in many patients there is a considerable degree of variability in IOP reduction among subjects. The reason for this interindividual variability is not entirely clear. Obviously differences in pharmacokinetic properties due to variable penetration of the drug through the cornea may be responsible. Alternatively, polymorphisms of the alpha-2 receptor may account for the differences in IOP-lowering efficacy of topical brimonidine. This hypothesis is tested in the present study. Polymorphisms of the alpha-2 receptor have been described in a number of previous studies. In addition, polymorphisms in the alpha-2 receptor gene have been shown to be functionally important, particularly a polymorphism of the alpha-2B receptor, which has a high allele frequency in caucasians.
- Conditions
- Ocular Physiology, Intraocular Pressure
- Being tested
- Brimonidine 0.2 %
- Keywords
- Brimonidine, alpha 2 receptor polymorphism, Intraocular Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brimonidine 0.2 %Drug
Brimonidine 0.2 % (Alphagan, Irvine, CA, USA), dose: 1 drop per eye
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | homozygote mutant: Insertion/Insertion (40 patients) Receives: Drug: Brimonidine 0.2 % |
| 2 | Active comparator | homozygote mutant: Deletion/Deletion (40 patients) Receives: Drug: Brimonidine 0.2 % |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure (IOP)
Measured: in total 10 minutes
alpha-2B receptor genotyping
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2008 (estimated)
- Study startMar 2008
- Primary completionNov 2014
- Study completionNov 2014
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 N/A
- Primary purpose
- Diagnosis
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00712777
- Sponsor's protocol ID
- OPHT-230408
- Status last verified
- Nov 2014
- First submitted
- 8 Jul 2008
- Last updated
- 21 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation Between Intraocular Pressure Lowering Effects of Topical Brimonidine and Alpha 2 Receptor Polymorphism
- ClinicalTrials.gov ID
- NCT00712777
- Acronym / sponsor ID
- OPHT-230408
- Conditions
- Ocular Physiology, Intraocular Pressure
- Keywords
- Brimonidine, alpha 2 receptor polymorphism, Intraocular Pressure
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 10 Jul 2008 (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.
Topical brimonidine is a recently introduced alpha 2 receptor agonist which is used in the therapy of intraocular pressure (IOP) reduction in patients with open angle glaucoma. Although adequate IOP reduction is achieved in many patients there is a considerable degree of variability in IOP reduction among subjects. The reason for this interindividual variability is not entirely clear. Obviously differences in pharmacokinetic properties due to variable penetration of the drug through the cornea may be responsible. Alternatively, polymorphisms of the alpha-2 receptor may account for the differences in IOP-lowering efficacy of topical brimonidine. This hypothesis is tested in the present study. Polymorphisms of the alpha-2 receptor have been described in a number of previous studies. In addition, polymorphisms in the alpha-2 receptor gene have been shown to be functionally important, particularly a polymorphism of the alpha-2B receptor, which has a high allele frequency in caucasians.
Study design
- Primary purpose
- Diagnosis
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Brimonidine 0.2 %homozygote mutant: Insertion/Insertion (40 patients) |
| 2 | Active comparator | Drug: Brimonidine 0.2 %homozygote mutant: Deletion/Deletion (40 patients) |
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
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- IOP between 12 and 16 mmHg
- Normal ophthalmic findings, ametropia < 3 Dpt.
- Results of alpha-2B receptor genotyping; subjects who fall within one of the following groups: group 1: homozygote mutant: I/I (n=40); group 2: homozygote mutant: D/D (n=40)
Key exclusion criteria (6 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 |
|---|---|---|
| Brimonidine 0.2 %Brimonidine 0.2 % (Alphagan, Irvine, CA, USA), dose: 1 drop per eye | Drug | 1, 2 |
Primary outcome
Intraocular pressure (IOP)
Time frame: in total 10 minutes
alpha-2B receptor genotyping
Time frame: 20 minutes
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 21 Nov 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brimonidine 0.2 % in people with Ocular Physiology and Intraocular Pressure, 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 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 21 Nov 2014. 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.
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 (IOP) (time frame: in total 10 minutes). The study lists 2 primary outcomes in all. 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 21 Nov 2014.