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Effect of Brimonidine on Corneal Thickness

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Augenarztpraxis Breisach.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Augenarztpraxis Breisach
ClinicalTrials.gov Identifier:
NCT01250236
First received: November 29, 2010
Last updated: December 2, 2010
Last verified: December 2010
History of Changes
  Purpose

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 Intervention
Impact of Brimonidine on the Cornea
 Drug: brimonidine 0.1%
Drug: placebo

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effect of Brimonidine on Corneal Thickness

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Augenarztpraxis Breisach:

Primary Outcome Measures:
  • corneal thickness [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • intraocular pressure [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: December 2010
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: PD Dr. Matthias Grueb, Augenarztpraxis Breisach
ClinicalTrials.gov Identifier: NCT01250236     History of Changes
Other Study ID Numbers: Grueb Klin CT
Study First Received: November 29, 2010
Last Updated: December 2, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Hyaluronic Acid
Brimonidine
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
 Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013