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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

May 16, 2008
May 29, 2012
May 2008
July 2009   (final data collection date for primary outcome measure)
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
General compliance measures for once daily dosing with TravAlert [ Time Frame: Daily ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00680329 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Glaucoma Adherence Study, Spain
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 to evaluate adherence to DuoTrav® when reinforced by the use of the Travalert™ Dosing Aid.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients were selected from one study site in Spain.

  • Ocular Hypertension
  • Primary Open Angle Glaucoma
  • 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
Travalert with DuoTrav
One drop in study eye(s) once daily in the evening for four months
Interventions:
  • Drug: Travoprost 0.004%/timolol 0.05% fixed combination eye drops (DuoTrav)
  • Device: Travalert Dosing Aid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
July 2009
July 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00680329
EMD-07-02, EMD-07-01
No
Alcon Research
Alcon Research
Not Provided
Not Provided
Alcon Research
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP