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OpenTrials
Completed

NCT Number: NCT00756184

Value of an Intervention to Enhance Adherence in Glaucoma Patients

A one-year, randomized, attention placebo-controlled trial investigating the value of comprehensive adherence specific interventions, over the course of one year, to enhance adherence in both (a) newly diagnosed open-angle glaucoma, or ocular hypertension patients, naive to medical therapy and (b) those who have failed monotherapy with any prostaglandin analogue (and are therefore candidates for adjunctive therapy) who then are randomized to receive only travoprost monotherapy. Subjects will be randomized to two different interventions involving direct physician education, each of which will take approximately the same amount of physician time: The first will be intensive adherence education that will continue throughout the year. The second will be intensive eye care education, but without any direct adherence education. All patients participating in the study will be monitored for adherence by the TDA. The study will demonstrate for the first time the role of adherence-specific training in improving patient adherence and will validate the TDA in monitoring and improving adherence in glaucoma. This will correlate with prior work that has documented that greater adherence is associated with marked improvement in intraocular pressure (IOP) control. A second goal will be seeing whether improving adherence will change the course of glaucoma therapy by making therapeutic failures into therapeutic successes by reducing the need for adjunctive therapy using only monotherapy with travoprost.

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Key information

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Newly diagnosed patients with glaucoma
  • Suboptimally controlled patients with glaucoma
  • Untreated baseline IOP greater than 21 mm Hg but less than 32 mm Hg
  • Patients who have not responded satisfactorily to PGA therapy
  • Patients who are about to have adjunctive therapy administered
  • Patients who consent to participate in this trial

Exclusion criteria

  • Glaucoma patients with high pressure
  • Advanced glaucoma
  • Patients with side effects to PGA therapy
  • Unwilling to participate

Treatment and study plan

TDA adherence monitor for travoprost therapy

Device

monitoring adherence to travoprost therapy

Other names: Adherence and IOP control after 12 months of therapy

TDA and travoprost monotherapy

Device

Patients will be prescribed travoprost therapy and will be followed up in a standard clinical fashion with a attention placebo at both baseline and 6 months

Primary outcomes

  1. Adherence rate between intervention and control groups

    Time frame: 1,3,6,12 months

Secondary outcomes

  1. IOP control

    Time frame: 12 months

    Monitoring of morning IOP control between the active and the control groups

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Collaborators

  • Alcon Research

Registry information

Official study title

1-year Randomized Control Trial Investigating the Value of an Intervention to Enhance Adherence in Glaucoma Patients Receiving Prostaglandin Monotherapy and in Patients Who Are Candidates for Adjunctive Therapy

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Sep 22, 2008
Registry last updated
Sep 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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