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Effect of Brimonidine on Corneal Thickness

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ClinicalTrials.gov Identifier: NCT01250236
Recruitment Status : Unknown
Verified December 2010 by Augenarztpraxis Breisach.
Recruitment status was:  Recruiting
First Posted : November 30, 2010
Last Update Posted : December 3, 2010
Sponsor:
Information provided by:
Augenarztpraxis Breisach

Brief 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 brimonidine has on the cornea. The aim of the study is to find out

  1. whether topical administration of brimonidine results in interaction with corneal alpha-2 adrenoceptors in terms of an increase in corneal thickness and
  2. whether there are any differences between the response corneal epithelium, stroma and endothelium show to alpha-2 adrenoceptor stimulation.

Condition or disease Intervention/treatment
Impact of Brimonidine on the Cornea Drug: brimonidine 0.1% Drug: placebo

Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effect of Brimonidine on Corneal Thickness
Study Start Date : December 2010
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
verum
brimonidine 0.1% eye drops twice daily
Drug: brimonidine 0.1%
brimonidine 0.1% eye drops twice daily

placebo
sodium hyaluronate 1.8mg/ml eye drops twice daily
Drug: placebo
sodium hyaluronate 1.8mg/ml eye drops twice daily




Primary Outcome Measures :
  1. corneal thickness [ Time Frame: 5 days ]

Secondary Outcome Measures :
  1. intraocular pressure [ Time Frame: 5 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
consecutive
Criteria

Inclusion Criteria:

  • healthy, 18-99 years, normal ophthalmologic history, consent to participate in the study

Exclusion Criteria:

  • any serious medical or neurologic conditions and/or regular use of local or systemic medications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01250236


Contacts
Contact: Matthias Grueb, Priv. Doz. Dr. 004976677766 matthias.grueb@web.de

Locations
Germany
Augenarztpraxis Recruiting
Breisach, Baden-Wuerttemberg, Germany, 79206
Contact: Matthias Grueb, Priv. Doz. Dr.    004976677766    matthias.grueb@web.de   
Principal Investigator: Matthias Grueb, Priv. Doz. Dr.         
Sponsors and Collaborators
Augenarztpraxis Breisach
Investigators
Study Director: Matthias Grueb, Priv. Doz. Dr. Augenarztpraxis Breisach

Responsible Party: PD Dr. Matthias Grueb, Augenarztpraxis Breisach
ClinicalTrials.gov Identifier: NCT01250236     History of Changes
Other Study ID Numbers: Grueb Klin CT
First Posted: November 30, 2010    Key Record Dates
Last Update Posted: December 3, 2010
Last Verified: December 2010

Keywords provided by Augenarztpraxis Breisach:
brimonidine
alpha-2 adrenoceptor
cornea
corneal thickness

Additional relevant MeSH terms:
Ophthalmic Solutions
Brimonidine Tartrate
Hyaluronic Acid
Pharmaceutical Solutions
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adjuvants, Immunologic
Immunologic Factors
Viscosupplements
Protective Agents