Glaucoma
Conditions
Keywords
Glaucoma, Adherence, Teaching
Brief summary
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.
Interventions
DEVICETDA adherence monitor for travoprost therapy
monitoring adherence to travoprost therapy
DEVICETDA and travoprost monotherapy
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
Sponsors
Alcon Research
Aristotle University Of Thessaloniki
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adherence rate between intervention and control groups | 1,3,6,12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IOP control | 12 months | Monitoring of morning IOP control between the active and the control groups |
Outcome results
None listed