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Long Term Use Of Xalacom In Patients Glaucoma Or Ocular Hypertension

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01191008
First Posted: August 30, 2010
Last Update Posted: July 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
August 26, 2010
August 30, 2010
December 22, 2016
July 17, 2017
July 17, 2017
October 2010
May 2015   (Final data collection date for primary outcome measure)
  • 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.
  • 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).
  • The incidence of adverse drug reactions. [ Time Frame: Max 104 weeks ]
  • Adverse drug reaction not expected from the LPD (unknown adverse drug reaction). [ Time Frame: Max 104 weeks ]
  • Efficacy rate for the patients of GLAUCOMA or OCULAR HYPERTENSION. [ Time Frame: Max 104 weeks ]
Complete list of historical versions of study NCT01191008 on ClinicalTrials.gov Archive Site
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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.
Not Provided
 
Long Term Use Of Xalacom In Patients Glaucoma Or Ocular Hypertension
Special Investigation Of Long Term Use Of Xalacom(Regulatory Post Marketing Commitment Plan)
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.
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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample
The patients whom an investigator involving A6641056 prescribes the Xalacom® Combination Eye Drops.
  • Glaucoma
  • Ocular Hypertension
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
Latan-timolol maleate fixed comb ophthalmic solution
Intervention: Drug: Latanoprost-timolol maleate fixed combination ophthalmic solution
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
661
May 2015
May 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients not administered Xalacom®.
Not Provided
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01191008
A6641056
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2017