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A Study of a Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00314158
First received: April 10, 2006
Last updated: March 1, 2012
Last verified: March 2012
History of Changes
  Purpose

The purpose of this study is to determine whether a glaucoma therapy is safe and effective in treating patients with open-angle glaucoma or ocular hypertension.


Condition Intervention Phase
Open-angle Glaucoma
Ocular Hypertension
 Drug: Brinzolamide 10 mg/ml + Timolol 5 mg/ml eye drops, suspension
Drug: Brinzolamide 10 mg/ml (AZOPT) eye drops, suspension
Drug: Timolol 5 mg/ml eye drops, solution
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean intra-ocular pressure (IOP)

Enrollment: 523
Study Start Date: November 2005
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brinzolamide +Timolol Drug: Brinzolamide 10 mg/ml + Timolol 5 mg/ml eye drops, suspension
One drop twice daily in each study eye for six months
Active Comparator: Brinzolamide Drug: Brinzolamide 10 mg/ml (AZOPT) eye drops, suspension
One drop twice daily in each study eye for six months
Other Name: AZOPT
Active Comparator: Timolol Drug: Timolol 5 mg/ml eye drops, solution
One drop twice daily in each study eye for six months

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Diagnosis of open-angle glaucoma
  • Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

  • Under 18
  • Pregnant
  • Other protocol-defined exclusion criteria may apply
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00314158

Locations
United States, Texas
United States Investigative Sites
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00314158     History of Changes
Other Study ID Numbers: C-05-24
Study First Received: April 10, 2006
Last Updated: March 1, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Timolol
Tetrahydrozoline
Brinzolamide
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013