Effect of Brimonidine on Corneal Thickness | NCT01250236

Studies
Effect of Brimonidine on Corneal Thickness

NCT01250236

Sponsor

Augenarztpraxis Breisach

Status

Unknown status

Last Update Posted

Dec 3, 2010Estimated

Enrollment

10Estimated

Phase

Not provided

Conditions

Impact of Brimonidine on the Cornea

Interventions

brimonidine 0.1%
placebo

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2010

Primary Completion Date

Dec 2010Estimated

Completion Date

Dec 2010Estimated

First Submitted Date

Nov 29, 2010

First Submission Date that Met QC Criteria

Nov 29, 2010

First Posted Date

Nov 30, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2010

Last Update Posted Date

Dec 3, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
brimonidine 0.1%	Drug	brimonidine 0.1% eye drops twice daily	verum

Measure	Description	Time Frame
corneal thickness		5 days

Measure	Description	Time Frame
intraocular pressure		5 days

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

consecutive

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Matthias Grueb, Priv. Doz. Dr.	Contact	004976677766		matthias.grueb@web.de

Overall Officials

Name	Affiliation	Role
Matthias Grueb, Priv. Doz. Dr.	Augenarztpraxis Breisach	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Augenarztpraxis	Recruiting	Breisach	Baden-Wurttemberg	79206	Germany

Type	Date	Date Unknown
Release	Jul 4, 2011
Reset	Aug 1, 2011

Submission Tracking

Estimated Results First Submitted Date

Jul 4, 2011

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jul 4, 2011			Aug 1, 2011