NCT00756184

Value of an Intervention to Enhance Adherence in Glaucoma Patients

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Aristotle University Of Thessaloniki · Academic / Other
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glaucoma

Interventions

Type	Name	Description
DEVICE	TDA adherence monitor for travoprost therapy	monitoring adherence to travoprost therapy
DEVICE	TDA 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

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-07-01
• Completion: 2009-09-01
• First posted: 2008-09-22
• Last updated: 2011-09-28