A Study of Intraocular Pressure (IOP) Reduction in Newly Diagnosed Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)

August 2, 2012 updated by: Allergan
This is an observational study and will evaluate IOP reduction in newly diagnosed patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

4812

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:

  • Newly diagnosed with primary open angle glaucoma or ocular hypertension

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. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.
Other: Standard of Care
Patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients With a Reduction in Intraocular Pressure (IOP) ≥ 5mmHg From Baseline
Time Frame: Baseline, 14 Weeks
Percentage of patients with a reduction in IOP≥5 mmHg from baseline. IOP is a measurement of the fluid pressure inside the eye. The minimum reduction of 5 mmHg was evaluated in the eye with the highest pressure at the baseline visit.
Baseline, 14 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients With an IOP Reduction ≥10% From Baseline
Time Frame: Baseline, 14 Weeks
Percentage of patients with an IOP reduction ≥10% from baseline. IOP is a measurement of the fluid pressure inside the eye. The minimum reduction of 10% was evaluated in the eye with the highest pressure at the baseline visit.
Baseline, 14 Weeks
Percentage of Patients With an IOP Reduction ≥20% From Baseline
Time Frame: Baseline, 14 Weeks
Percentage of patients with an IOP reduction ≥20% from baseline. IOP is a measurement of the fluid pressure inside the eye. The minimum reduction of 20% was evaluated in the eye with the highest pressure at the baseline visit.
Baseline, 14 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

November 1, 2010

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

June 25, 2012

First Submitted That Met QC Criteria

June 25, 2012

First Posted (Estimate)

June 27, 2012

Study Record Updates

Last Update Posted (Estimate)

September 5, 2012

Last Update Submitted That Met QC Criteria

August 2, 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/028
  • AGN-EPI-2010-01 (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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