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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00150267
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : November 5, 2008
Sponsor:
Information provided by:
Pfizer

Brief Summary:
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 or disease Intervention/treatment Phase
Glaucoma, Open-Angle Ocular Hypertension Drug: Xalacom Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 976 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 5-Year Postmarketing Safety Study Of Xalcom In Patients With Open Angle Glaucoma Or Ocular Hypertension
Study Start Date : February 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care Glaucoma
U.S. FDA Resources




Primary Outcome Measures :
  1. Incidence of increase of iris pigmentation
  2. incidence of development in darkening/lengthening/thickening of eyelashes and/or pigmentation of periorbital skin
  3. occurrence of ocular/periorbital adverse events
  4. occurrence of serious adverse events.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00150267


  Show 74 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00150267     History of Changes
Other Study ID Numbers: 912-OPT-0076-019
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: November 5, 2008
Last Verified: November 2008

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases