Glaucoma Adherence Study

NCT00676637 | Completed

• 2 other identifiers: EMD-07-01EMD-07-02
• Study Type: observational
• Target: 55
• Locations: 4 countries
• Sites: 4

Brief Summary

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

Conditions

Ocular Hypertension; Primary Open Angle Glaucoma

Keywords

Adherence; Compliance; Glaucoma; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• Mean Change from Baseline in Intraocular Pressure at 4 months

  As measured by Goldmann applanation tonometry

  Baseline, 4 months

Study Arms (1)

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); Device: Travalert Dosing Aid

Interventions

Travoprost 0.004%/timolol 0.05% fixed combination eye drops (DuoTrav) DRUG

One drop in study eye(s) once daily in the evening for four months

Also known as: DuoTrav

Travalert with DuoTrav

Travalert Dosing Aid DEVICE

Approved device used with DuoTrav and intended to provide an objective system for quantifying dosing and improving patient adherence

Travalert with DuoTrav

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients were selected from five study sites in the European Union.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (4)

France

Paris, APE 000Z, France

Location

Milan

Milan, 20132, Italy

Location

Maastricht

Maastricht, 6229, Netherlands

Location

London

London, Ec1V2PD, United Kingdom

Location

MeSH Terms

Conditions

Ocular Hypertension; Glaucoma, Open-Angle; Patient Compliance; Glaucoma

Interventions

Travoprost; Timolol; Duotrav

Condition Hierarchy (Ancestors)

Eye Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines

Study Officials

• Anna Grau

  Alcon Research

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2008
• First Posted: May 13, 2008
• Study Start: May 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: May 31, 2012

Record last verified: 2012-05

Locations

IT (1); GB (1); NL (1); FR (1)