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
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Purpose
This study is designed to evaluate the safety and tolerability of Xalacom in patients with primary glaucoma
| Condition | Intervention | Phase |
|---|---|---|
|
Glaucoma, Open-angle |
Drug: Xalacom |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| 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. |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Incidence of ocular hyperemia [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- safety of treatment [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- effectiveness in IOP lowering [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Enrollment: | 457 |
| Study Start Date: | October 2008 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Xalacom treatment
patients with primary glaucoma
|
Drug: Xalacom
Xalacom 1 drop into the affected eye daily
|
Detailed Description:
according to physicians decision, patients who met inclusion and exclusion criteria and sign the ICD
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients >18 years with primary open angle glaucoma or ocular hypertension
Criteria
Inclusion Criteria:
- primary open angle glaucoma
- ocular hypertension
- age >18 years
Exclusion Criteria:
- bradycardia
- obstructive pulmonary disease
- hypersensitivity to the drug
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00801437
Locations
| Slovakia | |
| Pfizer Investigational Site | |
| Banovce n. Bebravou, Slovakia, 957 01 | |
| Pfizer Investigational Site | |
| Banska Bystrica, Slovakia, 975 17 | |
| Pfizer Investigational Site | |
| Bojnice, Slovakia, 972 01 | |
| Pfizer Investigational Site | |
| Bratislava, Slovakia, 851 04 | |
| Pfizer Investigational Site | |
| Bratislava, Slovakia, 811 05 | |
| Pfizer Investigational Site | |
| Bratislava, Slovakia, 833 01 | |
| Pfizer Investigational Site | |
| Bratislava, Slovakia, 820 07 | |
| Pfizer Investigational Site | |
| Brezno, Slovakia, 977 01 | |
| Pfizer Investigational Site | |
| Dunajska Streda, Slovakia | |
| Pfizer Investigational Site | |
| Galanta, Slovakia | |
| Pfizer Investigational Site | |
| Kezmarok, Slovakia, 060 01 | |
| Pfizer Investigational Site | |
| Kosice, Slovakia, 040 01 | |
| Pfizer Investigational Site | |
| Kosice, Slovakia, 04004 | |
| Pfizer Investigational Site | |
| Krompachy, Slovakia, 053 42 | |
| Pfizer Investigational Site | |
| Lipany, Slovakia, 080 01 | |
| Pfizer Investigational Site | |
| Lucenec, Slovakia, 984 01 | |
| Pfizer Investigational Site | |
| Martin, Slovakia, 036 01 | |
| Pfizer Investigational Site | |
| Myjava, Slovakia, 907 13 | |
| Pfizer Investigational Site | |
| Nitra, Slovakia | |
| Pfizer Investigational Site | |
| Nova Bana, Slovakia, 968 01 | |
| Pfizer Investigational Site | |
| Nove Mesto n. Vahom, Slovakia, 915 01 | |
| Pfizer Investigational Site | |
| Nove Zamky, Slovakia | |
| Pfizer Investigational Site | |
| Poprad, Slovakia, 058 01 | |
| Pfizer Investigational Site | |
| Presov, Slovakia, 080 01 | |
| Pfizer Investigational Site | |
| Rimavska Sobota, Slovakia, 979 01 | |
| Pfizer Investigational Site | |
| Roznava, Slovakia, 048 01 | |
| Pfizer Investigational Site | |
| Ruzomberok, Slovakia, 034 01 | |
| Pfizer Investigational Site | |
| Sabinov, Slovakia, 083 01 | |
| Pfizer Investigational Site | |
| Sala, Slovakia | |
| Pfizer Investigational Site | |
| Sliac, Slovakia, 962 31 | |
| Pfizer Investigational Site | |
| Snina, Slovakia, 06901 | |
| Pfizer Investigational Site | |
| Spisska Nova Ves, Slovakia, 052 01 | |
| Pfizer Investigational Site | |
| Stara Lubovna, Slovakia, 064 01 | |
| Pfizer Investigational Site | |
| Stara Tura, Slovakia, 916 01 | |
| Pfizer Investigational Site | |
| Topolcany, Slovakia, 955 01 | |
| Pfizer Investigational Site | |
| Ziar nad Hronom, Slovakia, 965 01 | |
| Pfizer Investigational Site | |
| Zilina, Slovakia, 010 01 | |
| Pfizer Investigational Site | |
| Zlate Moravce, Slovakia | |
| Pfizer Investigational Site | |
| Zvolen, Slovakia, 960 01 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00801437 History of Changes |
| Other Study ID Numbers: | A6641053 |
| Study First Received: | November 19, 2008 |
| Last Updated: | June 28, 2011 |
| Health Authority: | Slovakia: State Institute for Drug Control |
Keywords provided by Pfizer:
|
glaucoma, open-angle, non-interventional study, safety, tolerability |
Additional relevant MeSH terms:
|
Glaucoma Glaucoma, Open-Angle Hypertension Ocular Hypertension |
Eye Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013