Non Interventional Study With Primary Open Angle Glaucoma and/or Ocular Hypertension Patients Treated With Xalacom® After Failure of Previous Antiglaucoma Therapy.
NCT00801437
Last updated date
ABOUT THIS STUDY
This study is designed to evaluate the safety and tolerability of Xalacom in patients with
primary glaucoma
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
The disease, disorder, syndrome, illness, or injury that is being studied.
Open-angle Glaucoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- primary open angle glaucoma
- ocular hypertension
- age >18 years
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- bradycardia
- obstructive pulmonary disease
- hypersensitivity to the drug
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Open-angle GlaucomaNon Interventional Study With Primary Open Angle Glaucoma and/or Ocular Hypertension Patients Treated With Xalacom® After Failure of Previous Antiglaucoma Therapy.
NCT00801437
- Banovce n. Bebravou,
- Banska Bystrica,
- Bojnice,
- Bratislava,
- Bratislava,
- Bratislava,
- Bratislava,
- Brezno,
- Dunajska Streda,
- Galanta,
- Kezmarok,
- Kosice,
- Kosice,
- Krompachy,
- Lipany,
- Lucenec,
- Martin,
- Myjava,
- Nitra,
- Nova Bana,
- Nove Mesto n. Vahom,
- Nove Zamky,
- Poprad,
- Presov,
- Rimavska Sobota,
- Roznava,
- Ruzomberok,
- Sabinov,
- Sala,
- Sliac,
- Snina,
- Spisska Nova Ves,
- Stara Lubovna,
- Stara Tura,
- Topolcany,
- Ziar nad Hronom,
- Zilina,
- Zlate Moravce,
- Zvolen,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| 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 to 99 Years (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 | 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 | June 2011 | |||