An Observational Study of Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) Who Switched IOP-lowering Treatments

April 9, 2019 updated by: Allergan
This study is a prospective, observational study of changing from any IOP-lowering treatment to a prostaglandin analogue-containing IOP-lowering medication for patients with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT). The decision to change medications lies with the physician according to their standard practice.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

358

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

POAG or OHT

Description

Inclusion Criteria:

  • Diagnosis of primary open angle glaucoma (POAG) or ocular hypertension (OHT)
  • Previously prescribed any IOP-lowering therapy which has been stopped and a new prostaglandin analogue -containing IOP-lowering therapy started

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
Patients with POAG or OHT
Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
Drug: Prostaglandin Analogue -Containing IOP-Lowering Therapy
Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Intraocular Pressure (IOP) in the Right Eye
Time Frame: Baseline, Week 12
IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement.
Baseline, Week 12
Change From Baseline in Intraocular Pressure (IOP) in the Left Eye
Time Frame: Baseline, Week 12
IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement.
Baseline, Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Assessment of Overall Tolerability With New Treatment Using a 4-Point Scale
Time Frame: 12 Weeks
The patient evaluated the tolerability of IOP-lowering medication therapy using a 4-Point Scale: Very good, Good, Moderate or Poor. Percentage of participants in each category is reported.
12 Weeks
Physician Assessment of Tolerability With New Treatment Using a 4-Point Scale
Time Frame: 12 Weeks
The physician evaluated the patient's tolerability of IOP-lowering medication therapy using a 4-Point Scale: Very good, Good, Moderate or Poor. Percentage of participants in each category is reported.
12 Weeks
Percentage of Participants Who Discontinue the Use of New Treatment Prior to 12 Weeks
Time Frame: 12 Weeks
12 Weeks
Percentage of Participants Who Continue the New Treatment After 12 Weeks
Time Frame: 12 Weeks
12 Weeks
Physician Assessment of Adherence to New Treatment Using a 4-Point Scale
Time Frame: 12 Weeks
The physician assessed the participant's adherence to new treatment using the following scale: Not Applicable, Worse, Equal or Better. The percentage of participants in each category is reported.
12 Weeks
Physician Assessment of Efficacy Using a 5-Point Scale
Time Frame: 12 Weeks
The physician evaluated efficacy (IOP lowering) using a 5-Point Scale: IOP lower than target, Reached Target IOP, IOP decreased but target not reached, No change or IOP increased. The percentage of participants in each category is reported.
12 Weeks
Percentage of Participants Reaching Individual IOP Target After 12 Weeks
Time Frame: 12 Weeks
12 Weeks

Collaborators and Investigators

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

Sponsor

Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

March 7, 2013

Primary Completion (Actual)

April 10, 2014

Study Completion (Actual)

April 10, 2014

Study Registration Dates

First Submitted

November 26, 2012

First Submitted That Met QC Criteria

November 26, 2012

First Posted (Estimate)

November 28, 2012

Study Record Updates

Last Update Posted (Actual)

April 18, 2019

Last Update Submitted That Met QC Criteria

April 9, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAF/AGN/OPH/GLA/037

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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