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: March 25, 2014
Last verified: March 2014

August 26, 2010
March 25, 2014
October 2010
May 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01191008 on ClinicalTrials.gov Archive Site
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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.
 
Enrolling by invitation
600
May 2014
May 2014   (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®.
Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT01191008
A6641056
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP