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Observational Study of Lumigan® 0.01% for Treatment of Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)

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ClinicalTrials.gov Identifier: NCT01568008
Recruitment Status : Completed
First Posted : April 2, 2012
Results First Posted : September 20, 2013
Last Update Posted : September 20, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is an observational study in patients with POAG or OHT that will collect data on the use of Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) in a routine clinical setting. Patients will be seen at baseline and at a follow-up visit approximately 8-12 weeks after baseline, as per normal clinical practice.

Condition or disease Intervention/treatment
Open-Angle Glaucoma Ocular Hypertension Drug: Bimatoprost 0.01% ophthalmic solution

Study Design

Study Type : Observational
Actual Enrollment : 933 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : October 2011
Primary Completion Date : September 2012
Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care Glaucoma
Drug Information available for: Bimatoprost
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
All participants
Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
Drug: Bimatoprost 0.01% ophthalmic solution
Bimatoprost 0.01% ophthalmic solution eye drops at a dose and frequency as determined by the physician.
Other Name: Lumigan®


Outcome Measures

Primary Outcome Measures :
  1. Intraocular Pressure (IOP) at Baseline [ Time Frame: Baseline ]
    IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eye at Baseline.

  2. Intraocular Pressure (IOP) at Week 12 [ Time Frame: Week 12 ]
    IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left eye and the right eye at Week 12. The lower the IOP values the greater the improvement.


Secondary Outcome Measures :
  1. Patient Assessment of Treatment Tolerability Using a 4-Point Scale [ Time Frame: 12 weeks ]
    Patients evaluated their tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed in each of the categories is reported.

  2. Physician Assessment of Treatment Tolerability Using a 4-Point Scale [ Time Frame: 12 weeks ]
    The Physician evaluated the patient's tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed in each of the categories is reported.

  3. Physician Reported Reasons for Treatment Discontinuation [ Time Frame: 12 weeks ]
    The number of patients who discontinued from treatment by category is reported. More than one reason may apply to each patient.

  4. Number of Patients Continuing Treatment After 12 Weeks [ Time Frame: 12 weeks ]
    The number of patients continuing treatment after 12 weeks was determined by the physician answering yes to the question: Is the patient continuing on Lumigan® 0.01% treatment?


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with POAG or OHT
Criteria

Inclusion Criteria:

  • Diagnosis of POAG or OHT
  • Prescribed Lumigan® 0.01%

Exclusion Criteria:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01568008


Locations
Belgium
Gent, Oost-Vlaanderen, Belgium
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
More Information

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01568008     History of Changes
Other Study ID Numbers: MAF/AGN/OPH/GLA/031
First Posted: April 2, 2012    Key Record Dates
Results First Posted: September 20, 2013
Last Update Posted: September 20, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Bimatoprost
Antihypertensive Agents