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

April 30, 2012
May 15, 2014
April 2012
February 2013   (final data collection date for primary outcome measure)
  • 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.
Intraocular Pressure (IOP) [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01589510 on ClinicalTrials.gov Archive Site
  • 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.
  • Physician Assessment of Effect on IOP [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]
  • Patient Assessment of Tolerability [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]
  • Physician Assessment of Tolerability [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Patients who Discontinued Treatment [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Patients who Continued Treatment [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Patients who Maintained Compliance with Treatment [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Lumigan® 0.01% in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)
Not Provided

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with POAG and OHT

  • Glaucoma, Open-Angle
  • Ocular Hypertension
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%
Lumigan® 0.01%
Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
Intervention: Drug: bimatoprost 0.01% ophthalmic solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
419
February 2013
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01589510
MAF/AGN/OPH/GLA/034
No
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP