Official 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”

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.

Study Type: Interventional

Study Design: Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: June 2009

Intervention(s) in this Clinical Trial

• Device: TDA monitor for adherence, 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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A
  • 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.
• Placebo Comparator: B
  • 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.

Primary Measures

• Comparison between IOP control in the adherence intervention group compared to the control group(attention placebo) Rate of adherence between the two groups measured by the TDA
  • Time Frame: 1,3,6,12 months
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Aristotle University Of Thessaloniki

Overall Clinical Trial Officials and Contacts

Anastasios G Konstas, MD, PhD Principal Investigator Glaucoma Unit, 1st University Dept AUT  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00756184

Study ID Number: A5133

ClinicalTrials.gov Identifier: NCT00756184

Health Authority: Greece: National Organization of Medicines