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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00300079
Recruitment Status : Completed
First Posted : March 8, 2006
Last Update Posted : November 18, 2016
Information provided by (Responsible Party):

Study Description
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 Design

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
Primary Completion Date : September 2007
Study Completion Date : September 2007

Arms and Interventions

Outcome Measures

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

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

Eligibility Criteria

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

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
Contacts and Locations

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

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

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00300079     History of Changes
Other Study ID Numbers: 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:
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
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