Non Interventional Study With Primary Open Angle Glaucoma and/or Ocular Hypertension Patients Treated With Xalacom® After Failure of Previous Antiglaucoma Therapy.
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00801437
First received: November 19, 2008
Last updated: June 28, 2011
Last verified: June 2011
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | November 19, 2008 | ||||
| Last Updated Date | June 28, 2011 | ||||
| Start Date ICMJE | October 2008 | ||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
|
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00801437 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
effectiveness in IOP lowering [ Time Frame: 12 months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Non Interventional Study With Primary Open Angle Glaucoma and/or Ocular Hypertension Patients Treated With Xalacom® After Failure of Previous Antiglaucoma Therapy. | ||||
| Official Title ICMJE | Non Interventional Study in Slovak Patients With Primary Open Angle Glaucoma and/or Ocular Hypertension Treated With Xalacom® After Failure of Previous Antiglaucoma Therapy Due to Ineffectivity or Intolerance. | ||||
| Brief Summary | This study is designed to evaluate the safety and tolerability of Xalacom in patients with primary glaucoma |
||||
| Detailed Description | according to physicians decision, patients who met inclusion and exclusion criteria and sign the ICD |
||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients >18 years with primary open angle glaucoma or ocular hypertension |
||||
| Condition ICMJE | Glaucoma, Open-angle | ||||
| Intervention ICMJE | Drug: Xalacom
Xalacom 1 drop into the affected eye daily |
||||
| Study Group/Cohort (s) | Xalacom treatment
patients with primary glaucoma
Intervention: Drug: Xalacom |
||||
| 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 ICMJE | Completed | ||||
| Enrollment ICMJE | 457 | ||||
| Completion Date | June 2009 | ||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Slovakia | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00801437 | ||||
| Other Study ID Numbers ICMJE | A6641053 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | ||||
| Study Sponsor ICMJE | Pfizer | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Pfizer | ||||
| Verification Date | June 2011 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||