Glaucoma Adherence Study (GAS)

May 29, 2012 updated by: Alcon Research

A Pilot Study of Adherence Assessment With the Travalert™ Dosing Aid in Patients With Ocular Hypertension or Primary Open-Angle Glaucoma Who Are Treated With the Travoprost/Timolol Maleate Fixed Combination Every Evening

The purpose of this study is evaluate adherence to DuoTrav® when reinforced by the use of the Travalert™ Dosing Aid.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study was conducted in France, UK, Italy, and Netherlands. An identical study was conducted in Spain under Protocol ID EMD-07-02. A combined enrollment number is presented.

Study Type

Observational

Enrollment (Actual)

55

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 were selected from five study sites in the European Union.

Description

Inclusion:

  • Provide informed consent.
  • Able to follow instructions and be willing and able to attend required study visits.
  • Able to read and complete study questionnaires.
  • Clinical diagnosis of ocular hypertension, or primary open-angle, pigment dispersion or exfoliation glaucoma in at least one eye.
  • Intraocular pressure considered safe, in both eyes, assuring clinical stability of vision and the optic nerve throughout the trial.
  • Currently treated with DuoTrav alone, dosed in the evening for at least for 30 days, at Visit 1.
  • Best corrected visual acuity of 20/200 Snellen or better in each eye.
  • Intraocular pressure ≤ 30 mm Hg in both eyes.
  • Evidence causing the investigator to consider the patient to be non-adherent, at some level, to their glaucoma medication.
  • Agree that their adherence could be improved by the intervention with the dosing aid described in this study.
  • Other protocol-defined inclusion criteria may apply.

Exclusion:

  • Presence of other primary or secondary glaucoma not listed in inclusion criterion.
  • Any abnormality preventing reliable applanation tonometry in the study eye(s).
  • Any known opacity or patient uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber of the study eye(s).
  • Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye.
  • Intraocular conventional surgery or laser surgery in study eye(s) less than three months prior to Visit 1.
  • Risk of visual field or visual acuity worsening as a consequence of participation in the trial, in the investigator's best judgment.
  • Progressive retinal or optic nerve disease from any cause.
  • Women of childbearing potential not using reliable means of birth control.
  • Women who are pregnant or lactating.
  • A condition, which in the opinion of the Principal Investigator, would interfere with optimal participation in the study, or which would present a special risk to the patient.
  • Participation in any other investigational study within 30 days prior to Visit 1.
  • Known medical history of allergy, sensitivity or poor tolerance to any components of the preparations to be used in this trial that is deemed clinically significant in the opinion of the Principal Investigator.
  • Unwillingness to risk the possibility of darkened irides, eyelash changes or periocular pigmentation.
  • History of, or at risk for uveitis or cystoid macular edema (CME).
  • Any physical disability which prevents the accurate use of the Travalert™ dosing aid.
  • Unable to accurately instill the travoprost/timolol fixed combination in the evening.
  • Other protocol-defined exclusion criteria may apply.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Travalert with DuoTrav
One drop in study eye(s) once daily in the evening for four months
Drug: Travoprost 0.004%/timolol 0.05% fixed combination eye drops (DuoTrav)
One drop in study eye(s) once daily in the evening for four months
Other Names:
  • DuoTrav
Device: Travalert Dosing Aid
Approved device used with DuoTrav and intended to provide an objective system for quantifying dosing and improving patient adherence

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change from Baseline in Intraocular Pressure at 4 months
Time Frame: Baseline, 4 months
As measured by Goldmann applanation tonometry
Baseline, 4 months

Collaborators and Investigators

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

Sponsor

Alcon Research

Investigators

  • Study Director: Anna Grau, Alcon Research

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, 2008

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

May 12, 2008

First Submitted That Met QC Criteria

May 12, 2008

First Posted (Estimate)

May 13, 2008

Study Record Updates

Last Update Posted (Estimate)

May 31, 2012

Last Update Submitted That Met QC Criteria

May 29, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMD-07-01 (Other Identifier: Alcon)
  • EMD-07-02 (Alcon)

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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