Long Term Use Of Xalacom In Patients Glaucoma Or Ocular Hypertension

NCT01191008

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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®.

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Advanced Information
Descriptive Information
Brief Title Long Term Use Of Xalacom In Patients Glaucoma Or Ocular Hypertension
Official Title Special Investigation Of Long Term Use Of Xalacom(Regulatory Post Marketing Commitment Plan)
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.
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The patients whom an investigator involving A6641056 prescribes the Xalacom® Combination Eye Drops.
Condition
  • Glaucoma
  • Ocular Hypertension
Intervention 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
Study Groups/Cohorts Latan-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 Status Completed
Actual Enrollment
 (submitted: August 12, 2015)
661
Original Estimated Enrollment
 (submitted: August 27, 2010)
600
Actual Study Completion Date May 2015
Actual Primary Completion Date May 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/Gender Not Provided
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01191008
Other Study ID Numbers A6641056
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2017