A Phase 4 interventional study of TDA adherence monitor for travoprost therapy and TDA and travoprost monotherapy in Glaucoma, sponsored by Aristotle University Of Thessaloniki. Completed. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2011-09-28.
Sponsored by Aristotle University Of Thessaloniki · Phase 4, Interventional, and Health services research
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.
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's enrollment of 107 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →Aristotle University Of Thessaloniki is the lead sponsor of 274 studies on the registry; 56 are open to participants now.
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Exclusion Criteria:
Intervention will consist of intensive teaching on the nature of glaucoma, value of IOP control, need to adhere to medical therapy and counseling on the proper use of travoprost eye drops.
Device: TDA adherence monitor for travoprost therapy
Intervention with travoprost therapy and TDA monitoring. Patients of this arm will also be prescribed travoprost and will be followed up in a standard clinical fashion. This group will receive a comparable amount of personal physician attention, but will not be given adherence, or glaucoma education and will not be told that their adherence will be monitored. Their attention placebo intervention will discuss the importance and techniques of good "eye health" (sunglasses, vitamins, cataract development, etc but no details, or discussion of either glaucoma or adherence) will insure that the study results are not a result of a change in physician attention to a patient, per se, rather than adherence training.
Device: TDA and travoprost monotherapy
monitoring adherence to travoprost therapy
Also known as: Adherence and IOP control after 12 months of therapy
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
Adherence rate between intervention and control groups
Time frame: 1,3,6,12 months
IOP control
Monitoring of morning IOP control between the active and the control groups
Time frame: 12 months
No study locations are listed for this record.
This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.
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Aristotle University Of Thessaloniki