Impact of Brimonidine on the CorneaNCT01250236
Effect of Brimonidine on Corneal Thickness
An observational study of Impact of Brimonidine on the Cornea, run by Augenarztpraxis Breisach at 1 site in Germany.
Trial summary
Brimonidine, an alpha-2 adrenoceptor agonist, is an effective and safe medication which is widely used in glaucoma treatment. Although it is known that it is quickly taken up by the cornea following topical administration and that the cornea has alpha-2 adrenoceptors there are only few studies available on the impact… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Impact of Brimonidine on the Cornea
- What is being tested?
- brimonidine 0.1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2010to Dec 2010
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: consecutive
Who may be able to join
- healthy, 18-99 years, normal ophthalmologic history, consent to participate in the study
Who cannot join
- any serious medical or neurologic conditions and/or regular use of local or systemic medications
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Augenarztpraxis
Breisach, Baden-Wurttemberg, 79206
Matthias Grueb, Priv. Doz. Dr., 004976677766, matthias.grueb@web.de
Matthias Grueb, Priv. Doz. Dr.
About this study
Brimonidine, an alpha-2 adrenoceptor agonist, is an effective and safe medication which is widely used in glaucoma treatment. Although it is known that it is quickly taken up by the cornea following topical administration and that the cornea has alpha-2 adrenoceptors there are only few studies available on the impact brimonidine has on the cornea. The aim of the study is to find out
- whether topical administration of brimonidine results in interaction with corneal alpha-2 adrenoceptors in terms of an increase in corneal thickness and
- whether there are any differences between the response corneal epithelium, stroma and endothelium show to alpha-2 adrenoceptor stimulation.
- Conditions
- Impact of Brimonidine on the Cornea
- Being tested
- brimonidine 0.1%, placebo
- Keywords
- brimonidine, alpha-2 adrenoceptor, cornea, corneal thickness
- Medical subject headings
- Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brimonidine 0.1%Drug
brimonidine 0.1% eye drops twice daily
placeboDrug
sodium hyaluronate 1.8mg/ml eye drops twice daily
| Study group | Role | What they receive |
|---|---|---|
| verum | brimonidine 0.1% eye drops twice daily Receives: Drug: brimonidine 0.1% | |
| placebo | sodium hyaluronate 1.8mg/ml eye drops twice daily Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
corneal thickness
Measured: 5 days
Secondary outcomes (1)
intraocular pressure
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2010 (estimated)
- Study startDec 2010
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impact of Brimonidine on the CorneaStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augenarztpraxis Breisach
- Sponsor type
- University, hospital or other
- Investigators
- Matthias Grueb, Priv. Doz. Dr., Study director, Augenarztpraxis Breisach
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01250236
- Sponsor's protocol ID
- Grueb Klin CT
- Status last verified
- Dec 2010
- First submitted
- 29 Nov 2010
- Last updated
- 3 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Brimonidine on Corneal Thickness
- ClinicalTrials.gov ID
- NCT01250236
- Acronym / sponsor ID
- Grueb Klin CT
- Conditions
- Impact of Brimonidine on the Cornea
- Keywords
- brimonidine, alpha-2 adrenoceptor, cornea, corneal thickness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Augenarztpraxis BreisachUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 30 Nov 2010 (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, an alpha-2 adrenoceptor agonist, is an effective and safe medication which is widely used in glaucoma treatment. Although it is known that it is quickly taken up by the cornea following topical administration and that the cornea has alpha-2 adrenoceptors there are only few studies available on the impact brimonidine has on the cornea. The aim of the study is to find out
- whether topical administration of brimonidine results in interaction with corneal alpha-2 adrenoceptors in terms of an increase in corneal thickness and
- whether there are any differences between the response corneal epithelium, stroma and endothelium show to alpha-2 adrenoceptor stimulation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| verum | – | Drug: brimonidine 0.1%brimonidine 0.1% eye drops twice daily |
| placebo | – | Drug: placebosodium hyaluronate 1.8mg/ml eye drops twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- consecutive
Key inclusion criteria (1 listed)
- healthy, 18-99 years, normal ophthalmologic history, consent to participate in the study
Key exclusion criteria (1 listed)
- any serious medical or neurologic conditions and/or regular use of local or systemic medications
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 0.1%brimonidine 0.1% eye drops twice daily | Drug | verum |
| placebosodium hyaluronate 1.8mg/ml eye drops twice daily | Drug | placebo |
Primary outcome
corneal thickness
Time frame: 5 days
1 secondary outcome
intraocular pressure
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2010.
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.
Matthias Grueb, Priv. Doz. Dr. study director
Augenarztpraxis Breisach
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 Impact of Brimonidine on the Cornea, run by Augenarztpraxis Breisach at 1 site in Germany.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 Dec 2010. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthias Grueb, Priv. Doz. Dr. (004976677766, matthias.grueb@web.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
corneal thickness (time frame: 5 days). 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 3 Dec 2010.