Long Term Use Of Xalacom In Patients Glaucoma Or Ocular Hypertension

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01191008
First received: August 26, 2010
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

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
Glaucoma
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.

  Eligibility

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.

Criteria

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 ClinicalTrials.gov identifier: NCT01191008

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

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01191008     History of Changes
Other Study ID Numbers: A6641056
Study First Received: August 26, 2010
Last Updated: July 23, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Hypertension
Ocular Hypertension
Glaucoma
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Timolol
Latanoprost
Maleic acid
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 29, 2014