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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00150267

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

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 
Study First Received: September 6, 2005
Last Updated: November 4, 2008
Health Authority: Sweden: Medical Products Agency

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

ClinicalTrials.gov processed this record on May 30, 2016