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Effect of Brimonidine on Corneal Thickness

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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
  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:


Further study details as provided by Augenarztpraxis Breisach:

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

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

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   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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

Additional relevant MeSH terms:
Ophthalmic Solutions
Tetrahydrozoline
Brimonidine Tartrate
Hyaluronic Acid
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic
Immunologic Factors
Viscosupplements
Protective Agents

ClinicalTrials.gov processed this record on July 19, 2017