Glaucoma Adherence Study, Spain (GAS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00680329
First received: May 16, 2008
Last updated: May 29, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention Phase
Ocular Hypertension
Primary Open Angle Glaucoma
Drug: Travoprost 0.004%/timolol 0.05% fixed combination eye drops (DuoTrav)
Device: Travalert Dosing Aid
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Change from Baseline in Intraocular Pressure at 4 months [ Time Frame: Baseline, 4 months ] [ Designated as safety issue: No ]
    As measured by Goldmann Applanation tonometry


Enrollment: 55
Study Start Date: May 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: DuoTrav
Device: Travalert Dosing Aid
Approved device used with DuoTrav and intended to provide an objective system for quantifying dosing and improving patient adherence
Other Name: Travalert Dosing Aid

Detailed Description:

This study was conducted in Spain. An identical study was conducted in France, UK, Italy, and Netherlands under Protocol ID EMD-07-01. A combined enrollment number is presented.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients were selected from one study site in Spain.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00680329

Locations
Spain
Spain
Madrid, Spain, 28040
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00680329     History of Changes
Other Study ID Numbers: EMD-07-02, EMD-07-01
Study First Received: May 16, 2008
Last Updated: May 29, 2012
Health Authority: Spain: Ministry of Health

Keywords provided by Alcon Research:
Adherence
Compliance
Glaucoma
Ocular Hypertension

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Timolol
Travoprost
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents

ClinicalTrials.gov processed this record on September 16, 2014