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Long Term Use Of Xalacom In Patients Glaucoma Or Ocular Hypertension

Last updated on November 12, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Glaucoma, Ocular Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Patients not administered Xalacom®.

NCT01191008
Pfizer
Completed
Long Term Use Of Xalacom In Patients Glaucoma Or Ocular Hypertension

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Descriptive Information
Brief TitleLong Term Use Of Xalacom In Patients Glaucoma Or Ocular Hypertension
Official TitleSpecial Investigation Of Long Term Use Of Xalacom(Regulatory Post Marketing Commitment Plan)
Brief SummaryThe 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.
Detailed DescriptionAll 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 TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationThe patients whom an investigator involving A6641056 prescribes the Xalacom® Combination Eye Drops.
Condition
  • Glaucoma
  • Ocular Hypertension
InterventionDrug: 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
Study Groups/CohortsLatan-timolol maleate fixed comb ophthalmic solution
Intervention: Drug: Latanoprost-timolol maleate fixed combination ophthalmic solution
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: August 12, 2015)
661
Original Estimated Enrollment
 (submitted: August 27, 2010)
600
Actual Study Completion DateMay 2015
Actual Primary Completion DateMay 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients not administered Xalacom®.
Sex/GenderNot Provided
AgesChild, Adult, Older Adult
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01191008
Other Study ID NumbersA6641056
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateFebruary 2017

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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