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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00150267 |
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Date of registration:
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06/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A 5-Year Postmarketing Safety Study Of Xalcom In Patients With Open Angle Glaucoma Or Ocular Hypertension
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Scientific title:
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A 5-Year Postmarketing Safety Study Of Xalcom In Patients With Open Angle Glaucoma Or Ocular Hypertension |
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Date of first enrolment:
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February 2002 |
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Target sample size:
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976 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00150267 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Australia
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Belgium
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Denmark
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France
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Germany
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Greece
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Ireland
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Italy
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Netherlands
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Spain
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Sweden
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United Kingdom
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with open angle glaucoma and/or ocular hypertension requiring a reduction of
IOP who were insufficiently responsive to topical betablockers
Exclusion Criteria:
- Previous and current treatment with any topical ophthalmic drug containing
prostaglandins; any condition in which treatment with the betablocking agent,
timolol, was contraindicated.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Glaucoma, Open-Angle
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Ocular Hypertension
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Intervention(s)
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Drug: Xalacom
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Primary Outcome(s)
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occurrence of ocular/periorbital adverse events
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Incidence of increase of iris pigmentation
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occurrence of serious adverse events.
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incidence of development in darkening/lengthening/thickening of eyelashes and/or pigmentation of periorbital skin
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Secondary ID(s)
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912-OPT-0076-019
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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