Non Interventional Study With Primary Open Angle Glaucoma and/or Ocular Hypertension Patients Treated With Xalacom® After Failure of Previous Antiglaucoma Therapy.
NCT00801437
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- primary open angle glaucoma
- ocular hypertension
- age >18 years
- bradycardia
- obstructive pulmonary disease
- hypersensitivity to the drug
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Descriptive Information | ||||
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Brief Title | Non Interventional Study With Primary Open Angle Glaucoma and/or Ocular Hypertension Patients Treated With Xalacom® After Failure of Previous Antiglaucoma Therapy. | |||
Official Title | 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 | Observational | |||
Study Design | 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 | Glaucoma, Open-angle | |||
Intervention | Drug: Xalacom
Xalacom 1 drop into the affected eye daily | |||
Study Groups/Cohorts | 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 | Completed | |||
Actual Enrollment | 457 | |||
Original Estimated Enrollment | 500 | |||
Actual Study Completion Date | June 2009 | |||
Actual Primary Completion Date | June 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender |
| |||
Ages | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Slovakia | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00801437 | |||
Other Study ID Numbers | A6641053 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor | Pfizer | |||
Collaborators | Not Provided | |||
Investigators |
| |||
PRS Account | Pfizer | |||
Verification Date | June 2011 |