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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01589510
First received: April 30, 2012
Last updated: May 15, 2014
Last verified: May 2014
  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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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:

  • 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: NCT01589510

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

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01589510     History of Changes
Other Study ID Numbers: MAF/AGN/OPH/GLA/034
Study First Received: April 30, 2012
Results First Received: January 21, 2014
Last Updated: May 15, 2014
Health Authority: Austria: Ethikkommission

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

ClinicalTrials.gov processed this record on October 29, 2014