A Study of Simbrinza™ Therapy in Patients With Open-Angle Glaucoma or Ocular Hypertension

September 17, 2015 updated by: Allergan
This study is a retrospective chart review to assess the tolerability and efficacy of treatment with Simbrinza™ used for patients with Open-Angle Glaucoma or Ocular Hypertension.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

150

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

Patients with Open-Angle Glaucoma or Ocular Hypertension treated in clinical practice.

Description

Inclusion Criteria:

  • Participants treated with Simbrinza™ for Intra-Ocular Pressure (IOP) lowering in at least one eye
  • Participants who had at least one-follow-up visit with tolerablity and efficacy data after Simbrinza™ treatment initiation.

Exclusion criteria:

  • Active ocular disease other than glaucoma or ocular hypertension
  • History of any intraocular surgery or glaucoma laser surgery within 3 months.

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
Simbrinza™
Patients treated with Simbrinza™ (brinzolamide 1%/brimonidine 0.2%) as standard of care in clinical practice. No study drug is administered in this study.
Other: No Intervention
No study drug is administered in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The time to first glaucoma therapy escalation occurrence or discontinuation of Simbrinza®
Time Frame: 2 Years
2 Years

Secondary Outcome Measures

Outcome Measure
Time Frame
The time to first glaucoma therapy escalation occurrence
Time Frame: 2 Years
2 Years
The time(s) to additional glaucoma therapy escalation occurrence(s)
Time Frame: 2 Years
2 Years
Specific AEs and SAEs occurring with a frequency of ≥5%
Time Frame: 2 Years
2 Years

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, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

January 22, 2015

First Submitted That Met QC Criteria

January 22, 2015

First Posted (Estimate)

January 28, 2015

Study Record Updates

Last Update Posted (Estimate)

September 21, 2015

Last Update Submitted That Met QC Criteria

September 17, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GMA-SIM-14-024

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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