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:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment

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
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

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

Contacts

Contact: Alcon Call Center

1-888-451-3937

Locations

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

Sponsors and Collaborators

Alcon Research

More Information

No publications provided

Responsible Party:	Alcon Research Ltd. ( James E. Teague, BS, Clinical Study Manager )
Study ID Numbers:	C-09-038
Study First Received:	August 18, 2009
Last Updated:	December 8, 2009
ClinicalTrials.gov Identifier:	NCT00961649 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Alcon Research:

Open-angle glaucoma
ocular hypertension
brinzolamide
brimonidine

Additional relevant MeSH terms:

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

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

ClinicalTrials.gov processed this record on February 08, 2010