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Brimonidine 0.1% Versus Brinzolamide 1% as Adjunctive Therapy to Latanoprost 0.005%

This study has been completed.
Sponsor:
Information provided by:
Allergan
ClinicalTrials.gov Identifier:
NCT00440141
First received: February 22, 2007
Last updated: December 26, 2007
Last verified: December 2007
History of Changes
  Purpose

Patients with glaucoma or ocular hypertension currently being treated with latanoprost 0.005%, and in need of additional IOP lowering will be randomized to receive either brimonidine 0.1% or brinzolamide 1% three-times daily as adjunctive therapy to latanoprost 0.005%


Condition Intervention Phase
Glaucoma
Ocular Hypertension
 Drug: latanoprost 0.005% eye drops and brimonidine 0.1% eye drops
Drug: latanoprost 0.005% eye drops and brinzolamide 1.0% eye drops
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • IOP [ Time Frame: Month 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerability [ Time Frame: Month 3 ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: July 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: latanoprost 0.005% eye drops and brimonidine 0.1% eye drops
latanoprost 0.005%, 1 drop nightly for 3 months and brimonidine 0.1% three-times daily for 3 months
Other Names:
  • Xalatan®
  • Alphagan® P
Active Comparator: 2 Drug: latanoprost 0.005% eye drops and brinzolamide 1.0% eye drops
latanoprost 0.005% 1 drop nightly for 3 months AND brinzolamide 1.0% 1% three-times daily for 3 months
Other Names:
  • Xalatan®
  • Azopt®

  Eligibility

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

Inclusion Criteria:

  • Glaucoma or ocular hypertension in both eyes
  • Currently being treated with latanoprost 0.005% QD
  • IOP greater than or equal to 18mm Hg on latanoprost 0.005%
  • Best-corrected VA of 20/200 or better in each eye
  • Visual field within 6 months of study entry

Exclusion Criteria:

  • Secondary glaucoma
  • Active intraocular inflammation or macular edema
  • Intraocular surgery or laser surgery within the past 3 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00440141

Locations
United States, Georgia
Atlanta, Georgia, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Affairs Allergan
  More Information

No publications provided by Allergan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Therapeutic Area Head, Allergan, Inc.
ClinicalTrials.gov Identifier: NCT00440141     History of Changes
Other Study ID Numbers: MA-AP01
Study First Received: February 22, 2007
Last Updated: December 26, 2007
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Glaucoma
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Tetrahydrozoline
Brimonidine
Latanoprost
Brinzolamide
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
 Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 30, 2012