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A Study Comparing IOP-Lowering Treatments to Bimatoprost in Patients With Primary Open Angle Glaucoma or Ocular Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01646151
First received: July 18, 2012
Last updated: May 15, 2014
Last verified: May 2014

July 18, 2012
May 15, 2014
May 2012
April 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 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 and right eyes at Week 12.
Change from Baseline in Intraocular Pressure (IOP) [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01646151 on ClinicalTrials.gov Archive Site
  • Physician Evaluation of IOP Lowering in the Study Eye(s) [ Time Frame: Week 12 ] [ 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 12 ] [ 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 12 ] [ 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.
  • Physician Assessment of Patient Compliance Compared to Previous Therapy [ Time Frame: Week 12 ] [ 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.
  • Percentage of Patients Who Discontinue Treatment With Bimatoprost-Containing Eye Drops Prior to 12 Weeks of Treatment [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Patients who discontinue treatment with bimatoprost-containing eye drops prior to 12 weeks of treatment was assessed as Yes or No.
  • Percentage of Patients Who Continue Treatment With Bimatoprost-Containing Eye Drops [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Patients who will continue treatment with bimatoprost-containing eye drops after 12 weeks of treatment was assessed as Yes or No.
  • IOP [ 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 ]
  • Physician Assessment of Patient Adherence with Treatment [ 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 Who Continue Treatment [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Patients Who Reach Their Individual IOP Target [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study Comparing IOP-Lowering Treatments to Bimatoprost in Patients With Primary Open Angle Glaucoma or Ocular Hypertension
Not Provided

An observational study comparing changing from an IOP-lowering treatment to a bimatoprost-containing IOP treatment in primary open-angle glaucoma (POAG) or ocular hypertension (OHT). Visits and treatment are per normal clinical practice.

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

Subjects with POAG and OHT

  • Glaucoma, Open-Angle
  • Ocular Hypertension
Drug: Bimatoprost
Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
Other Names:
  • LUMIGAN®
  • GANFORT®
Bimatoprost
Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
Intervention: Drug: Bimatoprost
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2580
April 2013
April 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of POAG or OHT
  • Previous use of IOP-lowering medication

Exclusion Criteria:

  • None
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Netherlands
 
NCT01646151
MAF/AGN/OPH/GLA/033
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