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

This study has been completed.
Sponsor:
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00300079
First received: March 6, 2006
Last updated: April 7, 2012
Last verified: June 2008
  Purpose

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 Intervention Phase
Primary Open Angle Glaucoma
Ocular Hypertension
Drug: brinzolamide 1.0%
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

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

Secondary Outcome Measures:
  • Safety throughout the 16 weeks of the study

Estimated Enrollment: 30
Study Start Date: September 2006
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00300079     History of Changes
Other Study ID Numbers: CM-05-13, CM-05-13
Study First Received: March 6, 2006
Last Updated: April 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Ocular Hypertension Patients

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Brinzolamide
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014