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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00150267
First received: September 6, 2005
Last updated: November 4, 2008
Last verified: November 2008
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 5-Year Postmarketing Safety Study Of Xalcom In Patients With Open Angle Glaucoma Or Ocular Hypertension

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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.

Enrollment: 976
Study Start Date: February 2002
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00150267

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

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00150267     History of Changes
Other Study ID Numbers: 912-OPT-0076-019
Study First Received: September 6, 2005
Last Updated: November 4, 2008
Health Authority: Sweden: Medical Products Agency

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

ClinicalTrials.gov processed this record on April 20, 2014