A Study Comparing IOP-Lowering Treatments to Bimatoprost in Patients With Primary Open Angle Glaucoma or Ocular Hypertension

May 15, 2014 updated by: Allergan
An observational study comparing changing from an IOP-lowering treatment to a bimatoprost-containing IOP treatment in primary open-angle glaucoma (POAG) or ocular hypertension (OHT). Visits and treatment are per normal clinical practice.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2580

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

Subjects with POAG and OHT

Description

Inclusion Criteria:

  • Diagnosis of POAG or OHT
  • Previous use of IOP-lowering medication

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
Bimatoprost
Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
Drug: Bimatoprost
Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
Other Names:
  • LUMIGAN®
  • GANFORT®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocular Pressure (IOP) at Baseline
Time Frame: Baseline
IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Baseline.
Baseline
IOP at Week 12
Time Frame: Week 12
IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Week 12.
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physician Evaluation of IOP Lowering in the Study Eye(s)
Time Frame: Week 12
IOP is a measurement of the fluid pressure inside the eye. Physicians evaluated IOP compared to the target IOP for each patient's study eye(s). The numbers of eyes in each category are presented.
Week 12
Patient Assessment of Tolerability on a 4-Point Scale
Time Frame: Week 12
Patient assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.
Week 12
Physician Assessment of Tolerability on a 4-Point Scale
Time Frame: Week 12
Physician assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.
Week 12
Physician Assessment of Patient Compliance Compared to Previous Therapy
Time Frame: Week 12
Physician assessment of patient compliance compared to previous therapy was assessed on a 3-point scale (better, equal, and worse). The numbers of patients in each category are presented.
Week 12
Percentage of Patients Who Discontinue Treatment With Bimatoprost-Containing Eye Drops Prior to 12 Weeks of Treatment
Time Frame: 12 Weeks
Patients who discontinue treatment with bimatoprost-containing eye drops prior to 12 weeks of treatment was assessed as Yes or No.
12 Weeks
Percentage of Patients Who Continue Treatment With Bimatoprost-Containing Eye Drops
Time Frame: Week 12
Patients who will continue treatment with bimatoprost-containing eye drops after 12 weeks of treatment was assessed as Yes or No.
Week 12

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

May 1, 2012

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

July 18, 2012

First Submitted That Met QC Criteria

July 18, 2012

First Posted (Estimate)

July 20, 2012

Study Record Updates

Last Update Posted (Estimate)

June 13, 2014

Last Update Submitted That Met QC Criteria

May 15, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAF/AGN/OPH/GLA/033

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.

Clinical Trials on Ocular Hypertension

Clinical Trials on Bimatoprost

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe