Effect of Brimonidine on Corneal Thickness

• Sponsor: Augenarztpraxis Breisach (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01250236
• Collaborator: (none)
• Enrollment: 10
• Location: 1

Study Details

Study Description

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. 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 or Disease	Intervention/Treatment	Phase
Impact of Brimonidine on the Cornea	Drug: brimonidine 0.1%; Drug: placebo

Study Design

• Study Type: Observational
• Anticipated Enrollment: 10 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Effect of Brimonidine on Corneal Thickness
• Study Start Date: Dec 1, 2010
• Anticipated Primary Completion Date: Dec 1, 2010
• Anticipated Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. corneal thickness [5 days]

Secondary Outcome Measures

1. intraocular pressure [5 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Augenarztpraxis	Breisach	Baden-Wuerttemberg	Germany	79206

Sponsors and Collaborators

• Augenarztpraxis Breisach

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01250236
• Other Study ID Numbers: Grueb Klin CT
• First Posted: Nov 30, 2010
• Last Update Posted: Dec 3, 2010
• Last Verified: Dec 1, 2010

• Keywords provided by , ,: brimonidine; alpha-2 adrenoceptor; cornea; corneal thickness
• Additional relevant MeSH terms: Corneal Diseases; Brimonidine Tartrate

Study Results

No Results Posted as of Dec 3, 2010