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

August 21, 2012 updated by: Allergan
This is a retrospective chart review and will assess changes in IOP after treatment with any fixed combination in patients who previously received monotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

4385

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Primary Open Angle Glaucoma or Ocular Hypertension

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 12 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 Weeks
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.
12 Weeks
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).
12 Weeks
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.
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

July 9, 2012

First Submitted That Met QC Criteria

July 9, 2012

First Posted (Estimate)

July 11, 2012

Study Record Updates

Last Update Posted (Estimate)

September 21, 2012

Last Update Submitted That Met QC Criteria

August 21, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAF/AGN/OPH/GLA/017
  • AGN-EPI-2009-02 (Other Identifier: Allergan)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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