Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

IOP-Lowering Efficacy of Brinzolamide 1.0% Added to Travoprost 0.004%/Timolol 0.5% Fixed Combination as Adjunctive Therapy

This study has been completed.
Information provided by (Responsible Party):
Alcon Research Identifier:
First received: September 27, 2006
Last updated: April 7, 2012
Last verified: April 2008

Uncontrolled glaucoma patients being treated with a prostaglandin agent alone or in combination with adjunctive drugs in fixed or unfixed combinations, will be switched from their current therapy to travoprost/timolol fixed combination and either Azopt or placebo

Condition Intervention Phase
Drug: Azopt
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: IOP-Lowering Efficacy of Brinzolamide 1.0% Added to Travoprost 0.004%/Timolol 0.5% Fixed Combination as Adjunctive Therapy

Resource links provided by NLM:

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • IOP lowering

Secondary Outcome Measures:
  • safety

Estimated Enrollment: 195
Study Start Date: September 2006
Study Completion Date: August 2007
Primary Completion Date: August 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:

  • Glaucoma

Exclusion Criteria:

  • Under 18
  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 identifier: NCT00382226

Australia, New South Wales
Sydney Study Site
Sydney, New South Wales, Australia, 2000
Sponsors and Collaborators
Alcon Research
Study Director: Mark Jasek Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research Identifier: NCT00382226     History of Changes
Other Study ID Numbers: CM-05-10
Study First Received: September 27, 2006
Last Updated: April 7, 2012
Health Authority: Australia: Ministry of Health

Keywords provided by Alcon Research:

Additional relevant MeSH terms:
Eye Diseases
Ocular Hypertension
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions processed this record on November 23, 2014