A Study of Patients With Primary Open Angle Glaucoma or Ocular Hypertension Switched to Lumigan® UD Monotherapy for Medical Reasons

April 9, 2019 updated by: Allergan
The study will evaluate patients diagnosed with primary open angle glaucoma or ocular hypertension who are switched to Lumigan® UD monotherapy for medical reasons in accordance with physician standard clinical practice. All treatment decisions lie with the physician.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1830

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

  • Germany
    • Baden-Württemberg
      • Wiesloch, Baden-Württemberg, Germany

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with primary open-angle glaucoma or ocular hypertension

Description

Inclusion Criteria:

  • Diagnosed with primary open-angle glaucoma or ocular hypertension
  • Previously prescribed intraocular pressure (IOP)-lowering medication with insufficient IOP control and is now being switched to Lumigan® UD for medical reasons

Exclusion Criteria:

  • None

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
Intervention / Treatment
Patients with POAG or OHT
Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
Drug: Bimatoprost Ophthalmic Solution
Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
Other Names:
  • Lumigan® UD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocular Pressure (IOP) in the Study Eye at Baseline
Time Frame: Baseline
IOP is a measurement of the fluid pressure inside the study eye.
Baseline
IOP in the Study Eye at Week 12
Time Frame: Week 12
IOP is a measurement of the fluid pressure inside the study eye.
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physician Assessment of IOP-Lowering Effect in the Study Eye on a 3-Point Scale
Time Frame: Baseline, 12 Weeks
IOP is a measurement of the fluid pressure inside the eye. Physicians evaluate IOP change from baseline in the study eye as better than expected, as expected, and worse than expected. The numbers of patients in each category are presented.
Baseline, 12 Weeks
Patient Assessment of Tolerability on a 4-Point Scale
Time Frame: 12 Weeks
Patient assessment of tolerability is assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.
12 Weeks
Physician Assessment of Tolerability on a 4-Point Scale
Time Frame: 12 Weeks
Physician assessment of tolerability is assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.
12 Weeks
Number of Patients Who Discontinue Treatment With Lumigan® UD Prior to 12 Weeks of Treatment
Time Frame: 12 Weeks
Patient discontinuation of treatment with Lumigan® UD prior to 12 weeks of treatment is assessed as Yes or No.
12 Weeks
Number of Patients Who Continue Treatment
Time Frame: 12 Weeks
Patient continuation of treatment with Lumigan® UD after the end of study participation is assessed as Yes or No.
12 Weeks
Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale
Time Frame: 12 Weeks
Physician assessment of patient compliance compared to previous therapy is assessed on a 3-point scale (better, equal, and worse). The numbers of patients in each category are presented.
12 Weeks

Collaborators and Investigators

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

Sponsor

Allergan

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.

General Publications

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 (Actual)

April 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

May 10, 2013

First Submitted That Met QC Criteria

May 10, 2013

First Posted (Estimate)

May 14, 2013

Study Record Updates

Last Update Posted (Actual)

April 19, 2019

Last Update Submitted That Met QC Criteria

April 9, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAF/AGN/OPH/GLA/038

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.

Clinical Trials on Ocular Hypertension

Clinical Trials on Bimatoprost Ophthalmic Solution

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe