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

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ClinicalTrials.gov Identifier: NCT00314158
Recruitment Status : Completed
First Posted : April 13, 2006
Last Update Posted : November 18, 2016
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
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 or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 523 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : November 2005
Primary Completion Date : January 2007
Study Completion Date : January 2007


Arm Intervention/treatment
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



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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00314158


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

Publications:
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00314158     History of Changes
Other Study ID Numbers: C-05-24
First Posted: April 13, 2006    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: March 2012

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