- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01632423
A Study of Lumigan® in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)
August 21, 2012 updated by: Allergan
This is an observational study of Lumigan® 0.01% (bimatoprost) treatment in clinical practice for patients with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
10337
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
-
-
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Berlin, Germany
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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 open angle glaucoma or ocular hypertension
Description
Inclusion Criteria:
- Diagnosed with primary open angle glaucoma or ocular hypertension
- Prescribed Lumigan®
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 |
---|---|
POAG or OHT
Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
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Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Intraocular Pressure (IOP)
Time Frame: Baseline, 14 Weeks
|
IOP is a measurement of the fluid pressure inside the eye.
A negative change from baseline indicates an improvement.
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Baseline, 14 Weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Assessment of Tolerability Using a 4-Point Scale
Time Frame: 14 Weeks
|
Patient assessment of tolerability using a 4-point scale (very good, good, moderate, and poor).
The number of patients assessed as good and very good combined are reported.
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14 Weeks
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Physician Assessment of Tolerability Using a 4-Point Scale
Time Frame: 14 Weeks
|
Physician assessment of tolerability using a 4-point scale (very good, good, moderate, and poor).
The number of patients assessed as good and very good combined are reported.
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14 Weeks
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Patients Who Discontinued Use of Lumigan® Prior to 14 Weeks
Time Frame: 14 Weeks
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Patients who discontinued Lumigan® prior to 14 weeks was assessed as Yes or No.
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14 Weeks
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Patients Who Will Continue Use of Lumigan® After 14 Weeks
Time Frame: 14 Weeks
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Patients who will continue use of Lumigan® after 14 weeks was assessed as Yes or No.
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14 Weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
February 1, 2010
Primary Completion (Actual)
November 1, 2010
Study Completion (Actual)
November 1, 2010
Study Registration Dates
First Submitted
June 25, 2012
First Submitted That Met QC Criteria
June 28, 2012
First Posted (Estimate)
July 3, 2012
Study Record Updates
Last Update Posted (Estimate)
September 21, 2012
Last Update Submitted That Met QC Criteria
August 21, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MAF/AGN/OPH/GLA/025
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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