Comparing Effects of Two Fixed Combinations Ophthalmic Solutions on Ocular Blood Flow - Full Text View

Sponsor:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00811850

Purpose

A 10 week evaluation, crossover design study including a 3 week washout period between treatments, to determine the effects of fixed combination brimonidine tartrate 0.2%/timolol maleate 0.5% and fixed combination dorzolamide hydrochloride-timolol maleate ophthalmic solutions on ocular blood flow as measured by retrobulbar blood flow

Condition	Intervention	Phase
Glaucoma	Drug: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution Drug: fixed combination of dorzolamide hydrochloride timolol maleate ophthalmic solution	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

Drug Information available for: Timolol Timolol maleate Brimonidine Brimonidine tartrate Dorzolamide Dorzolamide hydrochloride Cosopt

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

retrobulbar blood flow [ Time Frame: Week 5 and Week 10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse Events [ Time Frame: Week 5 and Week 10 ] [ Designated as safety issue: No ]

Estimated Enrollment:	15
Study Start Date:	December 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution	Drug: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution 1 drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks Other Name: Combigan™
Active Comparator: 2 Fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution	Drug: fixed combination of dorzolamide hydrochloride timolol maleate ophthalmic solution 1 drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks Other Name: Cosopt™

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age: 30 years or older.
Primary open-angle glaucoma (POAG) or ocular hypertensive in at least one eye.
Best corrected visual acuity at least 20/40 in at least one eye.

Exclusion Criteria:

History of acute angle-closure or a narrow, occludable anterior chamber angle by gonioscopy.
History of chronic or recurrent inflammatory eye diseases (e.g., scleritis, uveitis).
History or signs of intraocular trauma.
Any abnormality preventing reliable applanation tonometry.
Current use of any ophthalmic or systemic steroid which may interfere with this investigation.
Severe, unstable or uncontrolled cardiovascular, renal, or pulmonary disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00811850

Locations

United States, Indiana

Indianapolis, Indiana, United States

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

No publications provided

Responsible Party:	Medical Affairs Director, Allergan, Inc.
ClinicalTrials.gov Identifier:	NCT00811850 History of Changes
Other Study ID Numbers:	GMA-COM-08-009
Study First Received:	December 17, 2008
Last Updated:	August 11, 2009
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Glaucoma
Ocular Hypertension
Eye Diseases
Timolol
Brimonidine
Dorzolamide
Maleic acid
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Enzyme Inhibitors
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Carbonic Anhydrase Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012