Effect of Brimonidine on Corneal Thickness

December 2, 2010 updated by: Augenarztpraxis Breisach

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Wuerttemberg
      • Breisach, Baden-Wuerttemberg, Germany, 79206
        • Recruiting
        • Augenarztpraxis
        • Contact:
        • Principal Investigator:
          • Matthias Grueb, Priv. Doz. Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

consecutive

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
corneal thickness
Time Frame: 5 days
5 days

Secondary Outcome Measures

Outcome Measure
Time Frame
intraocular pressure
Time Frame: 5 days
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Augenarztpraxis Breisach

Investigators

  • Study Director: Matthias Grueb, Priv. Doz. Dr., Augenarztpraxis Breisach

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Anticipated)

December 1, 2010

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

November 29, 2010

First Submitted That Met QC Criteria

November 29, 2010

First Posted (Estimate)

November 30, 2010

Study Record Updates

Last Update Posted (Estimate)

December 3, 2010

Last Update Submitted That Met QC Criteria

December 2, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Grueb Klin CT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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