A 5-Year Postmarketing Safety Study Of Xalcom In Patients With Open Angle Glaucoma Or Ocular Hypertension

Pfizer976 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

976

Conditions

Glaucoma, Open-Angle Ocular Hypertension

Interventions

XalacomDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (74)

Outcomes

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.

Data from ClinicalTrials.gov

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Pfizer Investigational Site

Sydney, New South Wales, Australia

Pfizer Investigational Site

Sydney, New South Wales, Australia

Pfizer Investigational Site

Antwerp, Belgium

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Brussels, Belgium

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Edegem, Belgium

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Ghent, Belgium

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Leuven, Belgium

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Liège, Belgium

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København Ø, Denmark

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Odense C, Denmark

...and 64 more locations