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A Study of Lumigan® 0.01% in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01589510
First Posted: May 2, 2012
Last Update Posted: June 13, 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
A study of Lumigan® 0.01% as administered in standard practice for patients with POAG or OHT. All treatment decisions, care and diagnostic procedures provided are at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.

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 eyes at Baseline.

  • IOP at Week 14 [ Time Frame: Week 14 ]
    IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Week 14.


Secondary Outcome Measures:
  • Physician Evaluation of IOP Lowering in the Study Eye(s) [ Time Frame: Week 14 ]
    IOP is a measurement of the fluid pressure inside the eye. Physicians evaluated IOP compared to the target IOP for each patient's study eye(s). The numbers of eyes in each category are presented.

  • Patient Assessment of Tolerability on a 4-Point Scale [ Time Frame: Week 14 ]
    Patient assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.

  • Physician Assessment of Tolerability on a 4-Point Scale [ Time Frame: Week 14 ]
    Physician assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.

  • Percentage of Patients Who Discontinue Lumigan® 0.01% Prior to 14 Weeks of Treatment [ Time Frame: 14 Weeks ]
    Patients who discontinued Lumigan® 0.01% prior to 14 weeks was assessed as Yes or No.

  • Percentage of Patients Who Continue Lumigan® 0.01% Treatment [ Time Frame: Week 14 ]
    Patients who will continue Lumigan® 0.01% after 14 weeks of treatment was assessed as Yes or No.

  • Physician Assessment of Patient Compliance Compared to Previous Therapy [ Time Frame: Week 14 ]
    Physician assessment of patient compliance compared to previous therapy was assessed on a 3-point scale (better, equal, and worse). The numbers of patients in each category are presented.


Enrollment: 419
Study Start Date: April 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Lumigan® 0.01%
Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
Drug: bimatoprost 0.01% ophthalmic solution
Bimatoprost 0.01% ophthalmic solution (Lumigan® 0.01%) as prescribed by physician per standard practice for up to 14 weeks.
Other Name: Lumigan® 0.01%

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with POAG and 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): NCT01589510


Locations
Austria
Vienna, Austria
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01589510     History of Changes
Other Study ID Numbers: MAF/AGN/OPH/GLA/034
First Submitted: April 30, 2012
First Posted: May 2, 2012
Results First Submitted: January 21, 2014
Results First Posted: June 13, 2014
Last Update Posted: June 13, 2014
Last Verified: May 2014

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