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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.
Sponsor:
Information provided by:
Innovative Medical
ClinicalTrials.gov Identifier:
NCT00348023
First received: June 30, 2006
Last updated: February 7, 2007
Last verified: February 2007
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Innovative Medical:

  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

No publications provided

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

Additional relevant MeSH terms:
Glaucoma
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Timolol
Travoprost
Bimatoprost
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

ClinicalTrials.gov processed this record on May 21, 2013