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
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:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 14, 2014