24-Hour IOP-Lowering Effect of Brimonidine 0.1%

This study is ongoing, but not recruiting participants.

First Received: April 6, 2007 Last Updated: December 17, 2008 History of Changes

Sponsor:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00457795

Purpose

This study will evaluate the efficacy and safety of brimonidine 0.1% three-times daily in patients with glaucoma or ocular hypertension

Condition	Intervention	Phase
Open-Angle Glaucoma Ocular Hypertension	Drug: brimonidine 0.1% (Alphagan® P)	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Brimonidine Brimonidine tartrate

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

mean IOP for 24-hour period at 4 weeks [ Time Frame: 1 Month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

ocular perfusion pressure [ Time Frame: 1 Month ] [ Designated as safety issue: No ]

Estimated Enrollment:	15
Study Start Date:	December 2006
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: brimonidine 0.1% (Alphagan® P) Brimonidine 0.1%, 1 drop three-times daily for 4 weeks

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

patients with open-angle glaucoma or ocular hypertension

Exclusion Criteria:

allergy to brimonidine
inability to complete 24 hour stay for monitoring

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00457795

Locations

United States, California

San Diego, California, United States

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Affairs

Allergan

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Allergan, Inc. ( Medical Affairs Director )
Study ID Numbers:	MA-080806-2
Study First Received:	April 6, 2007
Last Updated:	December 17, 2008
ClinicalTrials.gov Identifier:	NCT00457795 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Neurotransmitter Agents
Adrenergic alpha-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Eye Diseases
Physiological Effects of Drugs
Vascular Diseases
Cardiovascular Agents
Antihypertensive Agents

Pharmacologic Actions
Adrenergic Agonists
Glaucoma
Therapeutic Uses
Glaucoma, Open-Angle
Cardiovascular Diseases
Hypertension
Ocular Hypertension
Brimonidine

ClinicalTrials.gov processed this record on February 08, 2010