Value of an Intervention to Enhance Adherence in Glaucoma Patients

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00756184
• Other study ID #: A5133
• Status: Completed
• Phase: Phase 4
• First received: September 19, 2008
• Last updated: September 27, 2011
• Start date: September 2007
• Est. completion date: September 2009

Study information

• Verified date: September 2011
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: September 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Glaucoma

Intervention

Device:
• TDA adherence monitor for travoprost therapy
monitoring adherence to travoprost therapy
• 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki	Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence rate between intervention and control groups		1,3,6,12 months	No
Secondary	IOP control	Monitoring of morning IOP control between the active and the control groups	12 months	No