Non Interventional Study With Primary Open Angle Glaucoma and/or Ocular Hypertension Patients Treated With Xalacom® After Failure of Previous Antiglaucoma Therapy.

February 17, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

according to physicians decision, patients who met inclusion and exclusion criteria and sign the ICD

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
457

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovakia
      • 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, 820 07
        • Pfizer Investigational Site
      • Bratislava, Slovakia, 811 05
        • Pfizer Investigational Site
      • Bratislava, Slovakia, 833 01
        • Pfizer Investigational Site
      • Bratislava, Slovakia, 851 04
        • 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
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients >18 years with primary open angle glaucoma or ocular hypertension

Description

Inclusion Criteria:

  • primary open angle glaucoma
  • ocular hypertension
  • age >18 years

Exclusion Criteria:

  • bradycardia
  • obstructive pulmonary disease
  • hypersensitivity to the drug

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Xalacom treatment
patients with primary glaucoma
Drug: Xalacom
Xalacom 1 drop into the affected eye daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Incidence of ocular hyperemia
Time Frame: 12 months
12 months
safety of treatment
Time Frame: 12 months
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
effectiveness in IOP lowering
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 3, 2008

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A6641053

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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