A Study of Patients With Primary Open Angle Glaucoma or Ocular Hypertension Switched to Lumigan® UD Monotherapy for Medical Reasons

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01853085
First received: May 10, 2013
Last updated: May 12, 2015
Last verified: May 2015

May 10, 2013
May 12, 2015
April 2013
March 2014   (final data collection date for primary outcome measure)
  • Intraocular Pressure (IOP) in the Study Eye at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    IOP is a measurement of the fluid pressure inside the study eye.
  • IOP in the Study Eye at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    IOP is a measurement of the fluid pressure inside the study eye.
Change from Baseline in Intraocular Pressure (IOP) [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01853085 on ClinicalTrials.gov Archive Site
  • Physician Assessment of IOP-Lowering Effect in the Study Eye on a 3-Point Scale [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
    IOP is a measurement of the fluid pressure inside the eye. Physicians evaluate IOP change from baseline in the study eye as better than expected, as expected, and worse than expected. The numbers of patients in each category are presented.
  • Patient Assessment of Tolerability on a 4-Point Scale [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Patient assessment of tolerability is 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: 12 Weeks ] [ Designated as safety issue: No ]
    Physician assessment of tolerability is assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.
  • Number of Patients Who Discontinue Treatment With Lumigan® UD Prior to 12 Weeks of Treatment [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Patient discontinuation of treatment with Lumigan® UD prior to 12 weeks of treatment is assessed as Yes or No.
  • Number of Patients Who Continue Treatment [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Patient continuation of treatment with Lumigan® UD after the end of study participation is assessed as Yes or No.
  • Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Physician assessment of patient compliance compared to previous therapy is assessed on a 3-point scale (better, equal, and worse). The numbers of patients in each category are presented.
  • Physician Assessment of IOP-Lowering Effect on a 3-Point Scale [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Patient Assessment of Tolerability on a 4-Point Scale [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Physician Assessment of Tolerability on a 4-Point Scale [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Patients who Discontinue Treatment [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Patients Prescribed by the Physician to Continue Treatment [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Patients With Primary Open Angle Glaucoma or Ocular Hypertension Switched to Lumigan® UD Monotherapy for Medical Reasons
Not Provided

The study will evaluate patients diagnosed with primary open angle glaucoma or ocular hypertension who are switched to Lumigan® UD monotherapy for medical reasons in accordance with physician standard clinical practice. All treatment decisions lie with the physician.

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

Patients with primary open-angle glaucoma or ocular hypertension

  • Glaucoma, Primary Open Angle
  • Ocular Hypertension
Drug: Bimatoprost Ophthalmic Solution
Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
Other Name: Lumigan® UD
Patients with POAG or OHT
Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
Intervention: Drug: Bimatoprost 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
1830
March 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosed with primary open-angle glaucoma or ocular hypertension
  • Previously prescribed intraocular pressure (IOP)-lowering medication with insufficient IOP control and is now being switched to Lumigan® UD for medical reasons

Exclusion Criteria:

  • None
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01853085
MAF/AGN/OPH/GLA/038
No
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
May 2015

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