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Bimatoprost Monotherapy vs. Dual Therapy With Travoprost and Timolol in Patients With Glaucoma and Ocular Hypertension

This study has been completed.

Sponsored by: Innovative Medical
Information provided by: Innovative Medical
ClinicalTrials.gov Identifier: NCT00348023
  Purpose

Evaluate the IOP-lowering efficacy and quality of life in patients using bimatoprost 0.03% monotherapy versus dual therapy with travoprost 0.004% and timolol 0.5% for the treatment of glaucoma or ocular hypertension.


Condition Intervention Phase
Glaucoma
Drug: Bimatoprost 0.03%, Travoprost 0.004%, Timolol 0.5%
Phase IV

Genetics Home Reference related topics:   early-onset glaucoma   

MedlinePlus related topics:   Glaucoma    High Blood Pressure   

ChemIDplus related topics:   Travoprost    Bimatoprost    Timolol    Timolol maleate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Randomized, Single Blind, Active Control, Parallel Assignment
Official Title:   Comparison of Bimatoprost 0.03% Monotherapy vs. Dual Therapy With Travoprost 0.004% and Timolol 0.5% in Patients With Glaucoma and Ocular Hypertension
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both

Criteria

Inclusion Criteria:

  • · Male or female > 18 years of age

    • Diagnosis of primary open-angle glaucoma or ocular hypertension
    • Untreated IOP > 18 mm Hg in each eye at the baseline evaluation
    • Ability to provide informed consent and likely to complete all study visits

Exclusion Criteria:

  • · Known contraindication to bimatoprost, travoprost, timolol, or any component of any study medication

    • Uncontrolled systemic disease
    • Active ocular disease other than POAG or ocular hypertension
    • Required use of ocular medications other than the study medications during the study (intermittent use of OTC artificial tear products will be permitted)
    • History of intraocular surgery within the last 3 months
    • Patient must not have discontinued use of any medication included in this study in the past for reasons of efficacy or intolerance
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00348023

Locations
United States, Pennsylvania
Dr. Noecker    
      Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators
Innovative Medical

Investigators
Principal Investigator:     Robert Noecker, MD     UPMC Eye Center    
  More Information


Study ID Numbers:   5179
First Received:   June 30, 2006
Last Updated:   February 7, 2007
ClinicalTrials.gov Identifier:   NCT00348023
Health Authority:   United States: Institutional Review Board

Study placed in the following topic categories:
Bimatoprost
Glaucoma
Eye Diseases
Vascular Diseases
Timolol
Travoprost
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Therapeutic Uses
Physiological Effects of Drugs
Adrenergic beta-Antagonists
Adrenergic Antagonists
Cardiovascular Diseases
Cardiovascular Agents
Anti-Arrhythmia Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008




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