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Observational Study of Lumigan® 0.01% Treatment for Patients With Primary Open Angle Glaucoma or Ocular Hypertension

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01489670
First Posted: December 12, 2011
Last Update Posted: March 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Allergan
  Purpose
This study will assess the efficacy, safety, tolerability and persistence of use of Lumigan ® 0.01% in patients diagnosed with primary open-angle glaucoma or ocular hypertension who are treated per routine clinical practice.

Condition Intervention
Glaucoma, Open-Angle Ocular Hypertension Drug: bimatoprost 0.01% ophthalmic solution

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • 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.

  • 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 and right eye at the Final Visit at approximately Week 12. The lower the IOP values the greater the improvement.


Secondary Outcome Measures:
  • Physician Evaluation of Efficacy Using a 5-Point Scale [ Time Frame: Week 12 ]
    The physician evaluated efficacy using a 5-point scale (IOP lower than the target, Target IOP reached, IOP decreased but target not reached, IOP increased or No change). The number of participants in each category is reported.

  • Patient Evaluation of Tolerability of Treatment Using a 4-Point Scale [ Time Frame: Week 12 ]
    Patients evaluated their tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The number of participants in each category is reported.

  • Physician Evaluation of Tolerability of Treatment [ Time Frame: Week 12 ]
    The physician evaluated the patient's tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The percentage of participants assessed in each category is reported.

  • Physician Reported Reasons for Early Discontinuation of Treatment [ 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.

  • Number of Patients Continuing Treatment After 12 Weeks [ Time Frame: Week 12 ]
    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?


Enrollment: 387
Study Start Date: September 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Lumigan® 0.01%
Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
Drug: bimatoprost 0.01% ophthalmic solution
Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
Other Name: Lumigan® 0.01%

  Eligibility

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 diagnosed with primary open-angle glaucoma or ocular hypertension
Criteria

Inclusion Criteria:

  • Diagnosis of primary open-angle glaucoma or ocular hypertension
  • Lumigan® 0.01% prescribed either as monotherapy or adjunctive to beta-blocker therapy

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): NCT01489670


Locations
Switzerland
Bülach, Zurich, Switzerland
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01489670     History of Changes
Other Study ID Numbers: MAF/AGN/OPH/GLA/032
First Submitted: December 1, 2011
First Posted: December 12, 2011
Results First Submitted: February 13, 2014
Results First Posted: March 28, 2014
Last Update Posted: March 28, 2014
Last Verified: February 2014

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