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Study of the Intraocular Pressure (IOP)-Lowering Efficacy of Azopt 1.0% Compared to Timolol 0.5% in Patients With Glaucoma or Ocular Hypertension

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ClinicalTrials.gov Identifier: NCT00300079
Recruitment Status : Completed
First Posted : March 8, 2006
Last Update Posted : November 18, 2016
Sponsor:
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
This is a multiple-dose study of the IOP-lowering efficacy of Azopt (brinzolamide) 1.0% compared to timolol 0.5% when added to a prostaglandin analogue (PGA) as adjunctive therapy over a 24 hour period in patients with glaucoma or ocular hypertension.

Condition or disease Intervention/treatment Phase
Primary Open Angle Glaucoma Ocular Hypertension Drug: brinzolamide 1.0% Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Multiple-Dose Study of the IOP-Lowering Efficacy of Azopt 1.0% Compared to Timolol 0.5% When Added to a PGA as Adjunctive Therapy Over a 24 Hour Period in Patients With Glaucoma or Ocular Hypertension
Study Start Date : September 2006
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources




Primary Outcome Measures :
  1. IOP-lowering at 8 and 16 weeks

Secondary Outcome Measures :
  1. Safety throughout the 16 weeks of the study


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary open angle glaucoma or ocular hypertension patients

Exclusion Criteria:

  • Women of childbearing potential
  • History of bronchial asthma, or severe chronic obstructive pulmonary disease
  • Presence of acute glaucoma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00300079


Locations
United States, California
San Diego, California, United States
Sponsors and Collaborators
Alcon Research
University of California, San Diego
Investigators
Principal Investigator: John Liu, PhD University of California, San Diego

Publications of Results:
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00300079     History of Changes
Other Study ID Numbers: CM-05-13
CM-05-13
First Posted: March 8, 2006    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: June 2008

Keywords provided by Alcon Research:
Ocular Hypertension Patients

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Timolol
Brinzolamide
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors