Long Term Use Of Xalacom In Patients Glaucoma Or Ocular Hypertension

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment
Glaucoma; Ocular Hypertension	Drug: Latanoprost-timolol maleate fixed combination ophthalmic solution

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.

Study Design

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Study Type :	Observational
Actual Enrollment :	661 participants
Observational Model:	Case-Only
Time Perspective:	Prospective
Official Title:	Special Investigation Of Long Term Use Of Xalacom(Regulatory Post Marketing Commitment Plan)
Study Start Date :	October 2010
Actual Primary Completion Date :	May 2015
Actual Study Completion Date :	May 2015

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Number of Participants WithTreatment-Related Adverse Events [ Time Frame: Max 104 weeks ]
   A treatment-related adverse event was any untoward medical occurrence attributed to latanoprost/timolol maleate in a participant who received latanoprost/timolol maleate. Relatedness to latanoprost/timolol maleate was assessed by the investigator.
2. Clinical Effectiveness Rate [ Time Frame: Max 104 weeks ]
   Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of effectiveness analysis population, was presented along with the corresponding exact 2sided 95% confidence interval. Overall effectiveness of latanoprost/timolol was determined by the investigator based on clinical symptoms and examinations. Clinical effectiveness was assessed according to the following categories: (1) effective, (2) not effective, or (3) not assessable at the end of observation period (Max 104 weeks).

Other Outcome Measures:

1. Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert [ Time Frame: Max 104 weeks ]
   A treatment-related adverse event was any untoward medical occurrence attributed to latanoprost/timolol maleate in a participant who received latanoprost/timolol maleate. Expectedness of the adverse event was determined according to Japanese package insert. Relatedness to latanoprost/timolol maleate was assessed by the investigator.

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	Child, Adult, Senior
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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Sponsors and Collaborators

Pfizer

Investigators

Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

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Additional Information:

To obtain contact information for a study center near you, click here. 

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01191008 History of Changes
Other Study ID Numbers:	A6641056
First Posted:	August 30, 2010
Results First Posted:	July 17, 2017
Last Update Posted:	July 17, 2017
Last Verified:	February 2017

Keywords provided by Pfizer:

Xalacom Regulatory post marketing commitment plan safety

Additional relevant MeSH terms:

Hypertension; Glaucoma; Ocular Hypertension; Vascular Diseases; Cardiovascular Diseases; Eye Diseases; Ophthalmic Solutions; Timolol; Latanoprost; Maleic acid	Pharmaceutical Solutions; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Anti-Arrhythmia Agents; Antihypertensive Agents; Enzyme Inhibitors