A One-Year Randomized Trial Investigating the Value Of an Intervention to Enhance Adherence in Newly-Diagnosed Glaucoma Patients Receiving Prostaglandin Monotherapy and in Patients Who Are Candidates for Adjunctive Therapy

Abstract

Purpose: : To evaluate the extent to which intensive directed adherence education and associated interventions influence the rate of adherence in medical glaucoma therapy.

Methods: : A one-year, randomized, attention placebo-controlled trial investigating the value of comprehensive adherence specific interventions in both 1) newly diagnosed open-angle glaucoma or ocular hypertensive subjects naive to medical therapy and 2) those who have failed monotherapy with any prostaglandin analogue. Subjects were randomized into two different interventions involving either intensive adherence and glaucoma education for one year; or intensive, equal-time eye care education without any direct adherence or glaucoma specific education. Patients then received travoprost monotherapy to enable adherence monitoring with a dosing aid electronic device (TDA). Morning IOP control, rate of adherence (% of days when the patient used of the medication), and persistency to therapy was compared between groups at 1, 3, 6, 9 and 12 months.

Results: : One hundred-seven patients have been recruited and evaluated to date. There were no baseline differences between the two groups with regard to age, vision, IOP, corneal thickness, vertical CD or mean visual field loss. Adherence rate as monitored by the TDA device was significantly better in the intervention group after 1 month (86.3% vs 69.4%), 3 months (87.2% vs 69.9%) and 6 months (87.7% vs 63.9%); (P<0.001)

Conclusions: : This is the first controlled ophthalmic study with a sufficient sample size in glaucoma to document the impact of a specific adherence intervention. It demonstrates a positive clinically significant impact of intensive teaching upon improving the rate of adherence to medical glaucoma therapy.

Clinical Trial: : www.clinicaltrials.gov NCT00756184

Keywords: intraocular pressure • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials