- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00348400
Brimonidine Purite 0.15% Versus Dorzolamide 2% Used as Adjunctive Therapy to Latanoprost
May 30, 2007 updated by: Innovative Medical
Evaluate the relative efficacy and tolerability of Alphagan P compared to Trusopt as adjunctive therapy
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 open-angle glaucoma or ocular hypertension
- IOP > 16 mm Hg in each eye at the latanoprost -treated baseline evaluation
- Presently on latanoprost monotherapy for at least 6 weeks
- Ability to provide informed consent and likely to complete all study visits
Exclusion Criteria:
· Known contraindication or allergy to brimonidine or any of its components
- Subjects must be naive to brimonidine 0.2% or brimonidine Purite 0.15% and dorzolamide 2%
- Uncontrolled systemic disease
- Active ocular disease other than glaucoma or ocular hypertension (e.g. uveitis, ocular infections, or severe dry eye). Patients with chronic mild blepharitis, cataract, age-related macular degeneration, or background diabetic retinopathy may be enrolled at the discretion of the investigator.
- Required use of ocular medications other than the study medications during the study (intermittent use of artificial tear product is allowed).
- Corneal abnormalities
- History of intraocular surgery within the last 3 months
- Female patients of childbearing potential who are pregnant, lactating, planning a pregnancy, or not using a reliable form of birth control
- Visual field loss, which in the opinion of the investigator, is functionally significant, or evidence of progressive visual field loss within the last year.
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)
June 1, 2007
Last Update Submitted That Met QC Criteria
May 30, 2007
Last Verified
May 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Eye Diseases
- Ocular Hypertension
- Glaucoma
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Enzyme Inhibitors
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Carbonic Anhydrase Inhibitors
- Pharmaceutical Solutions
- Ophthalmic Solutions
- Brimonidine Tartrate
- Dorzolamide
- Latanoprost
Other Study ID Numbers
- 5099
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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