Safety and Efficacy of Brinzolamide/Brimonidine Fixed Combination - Full Text View

Sponsor:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00961649

Purpose

The purpose of the study is to determine whether combination of brinzolamide and brimonidine is safe and effective in patients with open-angle glaucoma or ocular hypertension.

Condition	Intervention	Phase
Open-Angle Glaucoma Ocular Hypertension	Drug: brinzolamide/brimonidine Drug: brinzolamide Drug: brimonidine Drug: brinzolamide + brimonidine	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment

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 Azopt

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Mean IOP [ Time Frame: 8 AM, 10 AM, 3 PM, 5 PM ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Visual acuity [ Time Frame: 8 AM ] [ Designated as safety issue: Yes ]
Ocular Signs [ Time Frame: 8 AM ] [ Designated as safety issue: Yes ]
Fundus Parameters [ Time Frame: 8 AM ] [ Designated as safety issue: Yes ]
Pulse/Blood Pressure [ Time Frame: 8 AM ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	146
Study Start Date:	November 2009
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 brinzolamide/brimonidine combination	Drug: brinzolamide/brimonidine Effect of brinzolamide/brimonidine on IOP
Active Comparator: 2 brinzolamide	Drug: brinzolamide Effect of brinzolamide on IOP
Active Comparator: 3 brimonidine	Drug: brimonidine Effect of brimonidine on IOP
Active Comparator: 4 brinzolamide + brimonidine	Drug: brinzolamide + brimonidine Effect of brinzolamide + brimonidine on IOP

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients 18 years of age or older, of either sex and of any race diagnosed with open-angle glaucoma or ocular hypertension.

Exclusion Criteria:

Any form of glaucoma other than open-angle glaucoma
angle grade less than Grade 2
cup/disc ratio greater than 0.80
severe central visual field loss
chronic, recurrent or severe eye conditions
anticipated/current use of contraindicated medications
severe systemic conditions

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00961649

Locations

United States, Texas
Contact Alcon Call Center For Trial Locations
Fort Worth, Texas, United States, 76134

Sponsors and Collaborators

Alcon Research

More Information

No publications provided

Responsible Party:	James E. Teague, BS, Clinical Study Manager, Alcon Research Ltd.
ClinicalTrials.gov Identifier:	NCT00961649 History of Changes
Other Study ID Numbers:	C-09-038
Study First Received:	August 18, 2009
Last Updated:	March 10, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Alcon Research:

Open-angle glaucoma
ocular hypertension
brinzolamide
brimonidine

Additional relevant MeSH terms:

Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Brimonidine
Brinzolamide
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists

Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012