Not Signed In -
Glaucoma |
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Clinical Trial: A 5-Year Postmarketing Safety Study Of Xalcom In Patients With Open Angle Glaucoma Or Ocular Hypertension
This study is no longer recruiting patients.
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Purpose
To estimate the frequency of patients with ocular/periorbital adverse events. To identify any possible long-term adverse consequences of increased iris pigmentation and to follow serious adverse events throughout the study period.
| Condition | Intervention | Phase |
|---|---|---|
| Glaucoma, Open-Angle Ocular Hypertension | Drug: Xalacom | Phase IV |
MedlinePlus related topics: Eye Diseases; Glaucoma
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study
Further Study Details:
Primary Outcomes: Incidence of increase of iris pigmentation incidence of development in darkening/lengthening/thickening of eyelashes and/or pigmentation of periorbital skin occurrence of ocular/periorbital adverse events occurrence of serious adverse events.
Expected Total Enrollment: 1000
Expected Total Enrollment: 1000
Study start: February 2002
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
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.
Location Information
Study chairs or principal investigators
Pfizer CT.gov Call Center, Study Director, Pfizer
More Information
Study ID Numbers: 912-OPT-0076-019
Last Updated: September 7, 2005
Record first received: September 6, 2005
ClinicalTrials.gov Identifier: NCT00150267
Health Authority: Sweden: Medical Products Agency
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 7, 2005
Record first received: September 6, 2005
ClinicalTrials.gov Identifier: NCT00150267
Health Authority: Sweden: Medical Products Agency
ClinicalTrials.gov processed this record on 2005-09-13
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