Non-Interventional Study In Patients With Ocular Hypertension And Open Angle Glaucoma Treated With Xalatan And Xalacom
NCT01012245
Last updated date
ABOUT THIS STUDY
Non-interventional study to obtain real life data from the treatment with Xalatan and Xalacom
in Germany and to assess the long-term efficacy and tolerability under routine conditions.
Data were entered into an electronic case report form.
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
Eligibility Criteria
condition
Glaucoma, Ocular Hypertension
Sex
Females and Males
Age
0 +
Inclusion Criteria
Show details
- patients with ocular hypertension or glaucoma, defined by SmPC
Exclusion Criteria
Show details
- defined by SmPC
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Advanced Information
Descriptive Information | ||||
---|---|---|---|---|
Brief Title | Non-Interventional Study In Patients With Ocular Hypertension And Open Angle Glaucoma Treated With Xalatan And Xalacom | |||
Official Title | Project "XCHANGE" Non-Interventional Study | |||
Brief Summary | Non-interventional study to obtain real life data from the treatment with Xalatan and Xalacom in Germany and to assess the long-term efficacy and tolerability under routine conditions. Data were entered into an electronic case report form. | |||
Detailed Description | Not Provided | |||
Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | patients with glaucoma or ocular hypertension treated by office-based ophthalmologists | |||
Condition |
| |||
Intervention | Other: no intervention | |||
Study Groups/Cohorts | patients with glaucoma and ocular hypertension
Intervention: Other: no intervention | |||
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 | 28812 | |||
Original Actual Enrollment | 28871 | |||
Actual Study Completion Date | December 2008 | |||
Actual Primary Completion Date | December 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender |
| |||
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 | NCT01012245 | |||
Other Study ID Numbers | 912-OPT-0091-131 A6111100, 912-OPT-0091-131 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ) | |||
Study Sponsor | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | |||
Collaborators | Not Provided | |||
Investigators |
| |||
PRS Account | Pfizer | |||
Verification Date | February 2010 |