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.
University of California, San Diego
Information provided by (Responsible Party):
Alcon Research Identifier:
First received: March 6, 2006
Last updated: April 7, 2012
Last verified: June 2008

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)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its identifier: 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

No publications provided

Responsible Party: Alcon Research 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, Open-Angle
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions processed this record on April 17, 2014