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IOP Lowering Efficacy of Travoprost/Brinzolamide Fixed Combination Ophthalmic Suspension in Patients With Open-Angle Glaucoma or Ocular Hypertension

This study has been completed.
Information provided by (Responsible Party):
Alcon Research Identifier:
First received: September 10, 2007
Last updated: April 12, 2012
Last verified: February 2008
The purpose of this study is to compare the safety and IOP-lowering efficacy of a fixed combination of Travoprost/Brinzolamide Ophthalmuc Suspension dosed BID and QD, to TRAVATAN dosed QD and a Vehicle dosed BID in patients with open-angle glaucoma or ocular hypertension.

Condition Intervention Phase
Open-angle Glaucoma
Ocular Hypertension
Drug: Travoprost/brinzolamide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: IOP Lowering Efficacy of Travoprost/Brinzolamide Fixed Combination Ophthalmic Suspension in Patients With Open-Angle Glaucoma or Ocular Hypertension

Resource links provided by NLM:

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean IOP [ Time Frame: Time ]

Enrollment: 136
Study Start Date: August 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)

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

Inclusion Criteria:

  • Patients 18 years of age or older of either sex and any race with diagnosed open-angle glaucoma or confirmed ocular hypertension

Exclusion Criteria:

  • Age (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: NCT00527501

United States, California
Artesia, California, United States, 90701
Sponsors and Collaborators
Alcon Research
Study Director: Theresa Landry Alcon Research
  More Information

Responsible Party: Alcon Research Identifier: NCT00527501     History of Changes
Other Study ID Numbers: C-07-07 
Study First Received: September 10, 2007
Last Updated: April 12, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Alcon Research:
Open-angle glaucoma
ocular hypertension

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents processed this record on January 14, 2017