Glaucoma, Open-angleNCT00801437
Non Interventional Study With Primary Open Angle Glaucoma and/or Ocular Hypertension Patients Treated With Xalacom® After Failure of Previous Antiglaucoma Therapy.
An observational study of Glaucoma, Open-angle, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 39 sites in Slovakia.
Trial summary
This study is designed to evaluate the safety and tolerability of Xalacom in patients with primary glaucoma Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Glaucoma, Open-angle
- What is being tested?
- Xalacom
- How many people
- 457 participants
- Where
- 39 sitesSlovakia
- Study dates
- Oct 2008to Jun 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients >18 years with primary open angle glaucoma or ocular hypertension
Who may be able to join
- primary open angle glaucoma
- ocular hypertension
- age >18 years
Who cannot join
- bradycardia
- obstructive pulmonary disease
- hypersensitivity to the drug
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
Slovakia39 sites
Pfizer Investigational Site
Banovce N. Bebravou, 957 01
Pfizer Investigational Site
Banská Bystrica, 975 17
Pfizer Investigational Site
Bojnice, 972 01
Pfizer Investigational Site
Bratislava, 811 05
Pfizer Investigational Site
Bratislava, 820 07
Pfizer Investigational Site
Bratislava, 833 01
Pfizer Investigational Site
Bratislava, 851 04
Pfizer Investigational Site
Brezno, 977 01
Pfizer Investigational Site
Dunajská Streda
Pfizer Investigational Site
Galanta
Pfizer Investigational Site
Kežmarok, 060 01
Pfizer Investigational Site
Košice, 040 01
Pfizer Investigational Site
Košice, 04004
Pfizer Investigational Site
Krompachy, 053 42
Pfizer Investigational Site
Lipany, 080 01
Pfizer Investigational Site
Lučenec, 984 01
Pfizer Investigational Site
Martin, 036 01
Pfizer Investigational Site
Myjava, 907 13
Pfizer Investigational Site
Nitra
Pfizer Investigational Site
Nová Baňa, 968 01
Pfizer Investigational Site
Nove Mesto N. Vahom, 915 01
Pfizer Investigational Site
Nové Zámky
Pfizer Investigational Site
Poprad, 058 01
Pfizer Investigational Site
Prešov, 080 01
Pfizer Investigational Site
Rimavská Sobota, 979 01
Pfizer Investigational Site
Rožňava, 048 01
Pfizer Investigational Site
Ružomberok, 034 01
Pfizer Investigational Site
Sabinov, 083 01
Pfizer Investigational Site
Šaľa
Pfizer Investigational Site
Sliač, 962 31
Pfizer Investigational Site
Snina, 06901
Pfizer Investigational Site
Spišská Nová Ves, 052 01
Pfizer Investigational Site
Stará Ľubovňa, 064 01
Pfizer Investigational Site
Stará Turá, 916 01
Pfizer Investigational Site
Topoľčany, 955 01
Pfizer Investigational Site
Žiar nad Hronom, 965 01
Pfizer Investigational Site
Žilina, 010 01
Pfizer Investigational Site
Zlaté Moravce
Pfizer Investigational Site
Zvolen, 960 01
About this study
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.
This study is designed to evaluate the safety and tolerability of Xalacom in patients with primary glaucoma
Read the detailed description
according to physicians decision, patients who met inclusion and exclusion criteria and sign the ICD
- Conditions
- Glaucoma, Open-angle
- Being tested
- Xalacom
- Keywords
- glaucoma, open-angle, non-interventional study, safety, tolerability
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XalacomDrug
Xalacom 1 drop into the affected eye daily
| Study group | Role | What they receive |
|---|---|---|
| Xalacom treatment | patients with primary glaucoma Receives: Drug: Xalacom |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ocular hyperemia
Measured: 12 months
safety of treatment
Measured: 12 months
Secondary outcomes (1)
effectiveness in IOP lowering
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2008 (estimated)
- Study startOct 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-angleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 457 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00801437
- Sponsor's protocol ID
- A6641053
- Status last verified
- Jun 2011
- First submitted
- 19 Nov 2008
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00801437
- Acronym / sponsor ID
- A6641053
- Conditions
- Glaucoma, Open-angle
- Keywords
- glaucoma, open-angle, non-interventional study, safety, tolerability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 457 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 3 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Xalacom treatment | – | Drug: Xalacompatients with primary glaucoma |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients >18 years with primary open angle glaucoma or ocular hypertension
Key inclusion criteria (3 listed)
- primary open angle glaucoma
- ocular hypertension
- age >18 years
Key exclusion criteria (3 listed)
- bradycardia
- obstructive pulmonary disease
- hypersensitivity to the drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XalacomXalacom 1 drop into the affected eye daily | Drug | Xalacom treatment |
Primary outcome
Incidence of ocular hyperemia
Time frame: 12 months
safety of treatment
Time frame: 12 months
1 secondary outcome
effectiveness in IOP lowering
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, Open-angle, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 39 sites in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of ocular hyperemia (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.