A Study of Patients With Primary Open Angle Glaucoma or Ocular Hypertension Who Were Insufficiently Responsive to Monotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01637246
First received: July 9, 2012
Last updated: August 21, 2012
Last verified: August 2012
  Purpose

This is a retrospective chart review and will assess changes in IOP after treatment with any fixed combination in patients who previously received monotherapy.


Condition Intervention
Glaucoma, Open-Angle
Ocular Hypertension
Drug: Any Fixed Combination Therapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change From Baseline in Intraocular Pressure (IOP) [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
    IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement.


Secondary Outcome Measures:
  • Patient Assessment of Tolerability Using a 4-Point Scale [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Patient assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The percentage of patients assessed as good and very good combined are reported.

  • Physician Assessment of Tolerability Using a 4-Point Scale [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Physician assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The percentage of patients assessed as good and very good combined are reported.

  • Percentage of Patients Who Maintained Better Compliance With Treatment [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Percentage of patients who maintained better compliance with treatment than prior therapy was assessed by the patient on a 3-point scale (better, equal, and worse compliance).

  • Percentage of Patients Continuing on Therapy After 12 Weeks [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Percentage of patients continuing on therapy after 12 weeks was assessed as Yes or No.


Enrollment: 4385
Study Start Date: April 2009
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
POAG or OHT
Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
Drug: Any Fixed Combination Therapy
Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy. This was a retrospective chart review study, so no treatment was administered in this study.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with Primary Open Angle Glaucoma or Ocular Hypertension

Criteria

Inclusion Criteria:

  • Diagnosis of glaucoma or ocular hypertension
  • Previously treated with monotherapy followed by fixed combination therapy for at least 12 weeks

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: NCT01637246

Locations
Spain
Madrid, Spain
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01637246     History of Changes
Other Study ID Numbers: MAF/AGN/OPH/GLA/017, AGN-EPI-2009-02
Study First Received: July 9, 2012
Results First Received: August 21, 2012
Last Updated: August 21, 2012
Health Authority: Spain: Ethics Committee

Additional relevant MeSH terms:
Hypertension
Glaucoma
Ocular Hypertension
Glaucoma, Open-Angle
Vascular Diseases
Cardiovascular Diseases
Eye Diseases

ClinicalTrials.gov processed this record on September 16, 2014