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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01568008
First received: March 29, 2012
Last updated: July 18, 2013
Last verified: July 2013
  Purpose

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 Intervention
Open-Angle Glaucoma
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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:
  • Patient Assessment of Treatment Tolerability Using a 4-Point Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Physician Assessment of Treatment Tolerability Using a 4-Point Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Physician Reported Reasons for Treatment Discontinuation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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: 12 weeks ] [ Designated as safety issue: No ]
    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: 933
Study Start Date: October 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01568008

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

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01568008     History of Changes
Other Study ID Numbers: MAF/AGN/OPH/GLA/031
Study First Received: March 29, 2012
Results First Received: July 18, 2013
Last Updated: July 18, 2013
Health Authority: Belgium: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 01, 2014