Value of an Intervention to Enhance Adherence in Glaucoma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00756184
Recruitment Status : Completed
First Posted : September 22, 2008
Last Update Posted : September 28, 2011
Alcon Research
Information provided by (Responsible Party):
AGP Konstas, Aristotle University Of Thessaloniki

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.

Condition or disease Intervention/treatment Phase
Glaucoma Device: TDA adherence monitor for travoprost therapy Device: TDA and travoprost monotherapy Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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
Study Start Date : September 2007
Actual Primary Completion Date : July 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Travoprost

Arm Intervention/treatment
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.
Device: TDA adherence monitor for travoprost therapy
monitoring adherence to travoprost therapy
Other Name: Adherence and IOP control after 12 months of therapy

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.
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

Primary Outcome Measures :
  1. Adherence rate between intervention and control groups [ Time Frame: 1,3,6,12 months ]

Secondary Outcome Measures :
  1. IOP control [ Time Frame: 12 months ]
    Monitoring of morning IOP control between the active and the control groups

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00756184

Sponsors and Collaborators
Aristotle University Of Thessaloniki
Alcon Research
Principal Investigator: Anastasios G Konstas, MD, PhD Glaucoma Unit, 1st University Dept AUT

Responsible Party: AGP Konstas, Professor in Ophthalmology, Aristotle University Of Thessaloniki Identifier: NCT00756184     History of Changes
Other Study ID Numbers: A5133
First Posted: September 22, 2008    Key Record Dates
Last Update Posted: September 28, 2011
Last Verified: September 2011

Keywords provided by AGP Konstas, Aristotle University Of Thessaloniki:

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases
Antihypertensive Agents