We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01637246
Recruitment Status : Completed
First Posted : July 11, 2012
Results First Posted : September 21, 2012
Last Update Posted : September 21, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Glaucoma, Open-Angle Ocular Hypertension Drug: Any Fixed Combination Therapy

Study Design

Study Type : Observational
Actual Enrollment : 4385 participants
Observational Model: Cohort
Time Perspective: Retrospective
Study Start Date : April 2009
Primary Completion Date : November 2011
Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Change From Baseline in Intraocular Pressure (IOP) [ Time Frame: Baseline, 12 Weeks ]
    IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement.


Secondary Outcome Measures :
  1. Patient Assessment of Tolerability Using a 4-Point Scale [ Time Frame: 12 Weeks ]
    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.

  2. Physician Assessment of Tolerability Using a 4-Point Scale [ Time Frame: 12 Weeks ]
    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.

  3. Percentage of Patients Who Maintained Better Compliance With Treatment [ Time Frame: 12 Weeks ]
    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).

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


Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01637246


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

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01637246     History of Changes
Other Study ID Numbers: MAF/AGN/OPH/GLA/017
AGN-EPI-2009-02 ( Other Identifier: Allergan )
First Posted: July 11, 2012    Key Record Dates
Results First Posted: September 21, 2012
Last Update Posted: September 21, 2012
Last Verified: August 2012

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