Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Long Term Use Of Xalacom In Patients Glaucoma Or Ocular Hypertension

This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: August 26, 2010
Last updated: December 5, 2014
Last verified: December 2014

The objective of this Investigation is to evaluate the safety and efficacy of long-term treatment with Xalacom in medical practice. Also, occurrence of unknown and known adverse drug reactions (ADRs) in subjects treated with Xalacom will be monitored during the survey period, and whether an additional treatment outcome investigation and/or a post-marketing clinical study is required in the future will be determined.

Condition Intervention Phase
Ocular Hypertension
Drug: Latanoprost-timolol maleate fixed combination ophthalmic solution
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Special Investigation Of Long Term Use Of Xalacom(Regulatory Post Marketing Commitment Plan)

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The incidence of adverse drug reactions. [ Time Frame: Max 104 weeks ] [ Designated as safety issue: Yes ]
  • Adverse drug reaction not expected from the LPD (unknown adverse drug reaction). [ Time Frame: Max 104 weeks ] [ Designated as safety issue: Yes ]
  • Efficacy rate for the patients of glaucoma or ocular hypertension. [ Time Frame: Max 104 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: October 2010
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Latan-timolol maleate fixed comb ophthalmic solution Drug: Latanoprost-timolol maleate fixed combination ophthalmic solution
Xalacom® Combination Eye Drops depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. "One drop should be applied to the affected eye(s) once daily".
Other Name: Xalacom

Detailed Description:

All the patients whom an investigator prescribes the first Xalacom® should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The patients whom an investigator involving A6641056 prescribes the Xalacom® Combination Eye Drops.


Inclusion Criteria:

  • Patients need to be administered Xalacom® in order to be enrolled in the surveillance.

Exclusion Criteria:

  • Patients not administered Xalacom®.
  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 identifier: NCT01191008

Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer Identifier: NCT01191008     History of Changes
Other Study ID Numbers: A6641056
Study First Received: August 26, 2010
Last Updated: December 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Xalacom Regulatory post marketing commitment plan safety

Additional relevant MeSH terms:
Ocular Hypertension
Cardiovascular Diseases
Eye Diseases
Vascular Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on February 25, 2015