- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00348023
Bimatoprost Monotherapy vs. Dual Therapy With Travoprost and Timolol in Patients With Glaucoma and Ocular Hypertension
February 7, 2007 updated by: Innovative Medical
Comparison of Bimatoprost 0.03% Monotherapy vs. Dual Therapy With Travoprost 0.004% and Timolol 0.5% in Patients With Glaucoma and Ocular Hypertension
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- Dr. Noecker
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robert Noecker, MD, UPMC Eye Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
June 30, 2006
First Submitted That Met QC Criteria
June 30, 2006
First Posted (Estimate)
July 4, 2006
Study Record Updates
Last Update Posted (Estimate)
February 9, 2007
Last Update Submitted That Met QC Criteria
February 7, 2007
Last Verified
February 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Glaucoma
- Ocular Hypertension
- Hypertension
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Timolol
- Travoprost
- Bimatoprost
Other Study ID Numbers
- 5179
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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