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Clinical Trials/NCT00756184
NCT00756184CompletedPhase 4

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

Aristotle University Of Thessaloniki0 sites107 target enrollmentStarted: September 2007Last updated:
Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
107
Primary Endpoint
Adherence rate between intervention and control groups

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
21 Years to 80 Years (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

Adherence rate between intervention and control groups

Time Frame: 1,3,6,12 months

Secondary Outcomes

  • IOP control(12 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

AGP Konstas

Professor in Ophthalmology

Aristotle University Of Thessaloniki

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