NCT01250236

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 30, 2010

Completed
1 day until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

December 3, 2010

Status Verified

December 1, 2010

Enrollment Period

Same day

First QC Date

November 29, 2010

Last Update Submit

December 2, 2010

Conditions

Impact of Brimonidine on the Cornea

Keywords

brimonidinealpha-2 adrenoceptorcorneacorneal thickness

Outcome Measures

Primary Outcomes (1)

  • corneal thickness

    5 days

Secondary Outcomes (1)

  • intraocular pressure

    5 days

Study Arms (2)

verum

brimonidine 0.1% eye drops twice daily

Drug: brimonidine 0.1%

placebo

sodium hyaluronate 1.8mg/ml eye drops twice daily

Drug: placebo

Interventions

brimonidine 0.1%DRUG

brimonidine 0.1% eye drops twice daily

verum
placeboDRUG

sodium hyaluronate 1.8mg/ml eye drops twice daily

placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

consecutive

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Augenarztpraxis

Breisach, Baden-Wurttemberg, 79206, Germany

RECRUITING

MeSH Terms

Conditions

Corneal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Matthias Grueb, Priv. Doz. Dr.

    Augenarztpraxis Breisach

    STUDY DIRECTOR

Central Study Contacts

Matthias Grueb, Priv. Doz. Dr.

CONTACT

004976677766matthias.grueb@web.de

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 29, 2010

First Posted

November 30, 2010

Study Start

December 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

December 3, 2010

Record last verified: 2010-12

Locations

DE(1)