Non Interventional Study With Primary Open Angle Glaucoma and/or Ocular Hypertension Patients Treated With Xalacom® After Failure of Previous Antiglaucoma Therapy.
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00801437
Collaborator
(none)
457
39
8
11.7
1.5
Study Details
Study Description
Brief Summary
This study is designed to evaluate the safety and tolerability of Xalacom in patients with primary glaucoma
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Detailed Description
according to physicians decision, patients who met inclusion and exclusion criteria and sign the ICD
Study Design
Study Type:
Observational
Actual Enrollment
:
457 participants
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.
Study Start Date
:
Oct 1, 2008
Actual Primary Completion Date
:
Jun 1, 2009
Actual Study Completion Date
:
Jun 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Xalacom treatment patients with primary glaucoma |
Drug: Xalacom
Xalacom 1 drop into the affected eye daily
|
Outcome Measures
Primary Outcome Measures
- Incidence of ocular hyperemia [12 months]
- safety of treatment [12 months]
Secondary Outcome Measures
- effectiveness in IOP lowering [12 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
primary open angle glaucoma
-
ocular hypertension
-
age >18 years
Exclusion Criteria:
-
bradycardia
-
obstructive pulmonary disease
-
hypersensitivity to the drug
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Banovce N. Bebravou | Slovakia | 957 01 | |
| 2 | Pfizer Investigational Site | Banska Bystrica | Slovakia | 975 17 | |
| 3 | Pfizer Investigational Site | Bojnice | Slovakia | 972 01 | |
| 4 | Pfizer Investigational Site | Bratislava | Slovakia | 811 05 | |
| 5 | Pfizer Investigational Site | Bratislava | Slovakia | 820 07 | |
| 6 | Pfizer Investigational Site | Bratislava | Slovakia | 833 01 | |
| 7 | Pfizer Investigational Site | Bratislava | Slovakia | 851 04 | |
| 8 | Pfizer Investigational Site | Brezno | Slovakia | 977 01 | |
| 9 | Pfizer Investigational Site | Dunajska Streda | Slovakia | ||
| 10 | Pfizer Investigational Site | Galanta | Slovakia | ||
| 11 | Pfizer Investigational Site | Kezmarok | Slovakia | 060 01 | |
| 12 | Pfizer Investigational Site | Kosice | Slovakia | 040 01 | |
| 13 | Pfizer Investigational Site | Kosice | Slovakia | 04004 | |
| 14 | Pfizer Investigational Site | Krompachy | Slovakia | 053 42 | |
| 15 | Pfizer Investigational Site | Lipany | Slovakia | 080 01 | |
| 16 | Pfizer Investigational Site | Lucenec | Slovakia | 984 01 | |
| 17 | Pfizer Investigational Site | Martin | Slovakia | 036 01 | |
| 18 | Pfizer Investigational Site | Myjava | Slovakia | 907 13 | |
| 19 | Pfizer Investigational Site | Nitra | Slovakia | ||
| 20 | Pfizer Investigational Site | Nova Bana | Slovakia | 968 01 | |
| 21 | Pfizer Investigational Site | Nove Mesto N. Vahom | Slovakia | 915 01 | |
| 22 | Pfizer Investigational Site | Nove Zamky | Slovakia | ||
| 23 | Pfizer Investigational Site | Poprad | Slovakia | 058 01 | |
| 24 | Pfizer Investigational Site | Presov | Slovakia | 080 01 | |
| 25 | Pfizer Investigational Site | Rimavska Sobota | Slovakia | 979 01 | |
| 26 | Pfizer Investigational Site | Roznava | Slovakia | 048 01 | |
| 27 | Pfizer Investigational Site | Ruzomberok | Slovakia | 034 01 | |
| 28 | Pfizer Investigational Site | Sabinov | Slovakia | 083 01 | |
| 29 | Pfizer Investigational Site | Sala | Slovakia | ||
| 30 | Pfizer Investigational Site | Sliac | Slovakia | 962 31 | |
| 31 | Pfizer Investigational Site | Snina | Slovakia | 06901 | |
| 32 | Pfizer Investigational Site | Spisska Nova Ves | Slovakia | 052 01 | |
| 33 | Pfizer Investigational Site | Stara Lubovna | Slovakia | 064 01 | |
| 34 | Pfizer Investigational Site | Stara Tura | Slovakia | 916 01 | |
| 35 | Pfizer Investigational Site | Topolcany | Slovakia | 955 01 | |
| 36 | Pfizer Investigational Site | Ziar nad Hronom | Slovakia | 965 01 | |
| 37 | Pfizer Investigational Site | Zilina | Slovakia | 010 01 | |
| 38 | Pfizer Investigational Site | Zlate Moravce | Slovakia | ||
| 39 | Pfizer Investigational Site | Zvolen | Slovakia | 960 01 |
Sponsors and Collaborators
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00801437
Other Study ID Numbers:
- A6641053
First Posted:
Dec 3, 2008
Last Update Posted:
Feb 18, 2021
Last Verified:
Jun 1, 2011
Keywords provided by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Additional relevant MeSH terms: