Topical apraclonidine hydrochloride in eyes with poorly controlled glaucoma. The Apraclonidine Maximum Tolerated Medical Therapy Study Group.

OBJECT

We determined whether the addition of topical apraclonidine hydrochloride to eyes receiving maximal medical therapy, with inadequate intraocular pressure (IOP) control, and scheduled to undergo surgery, could adequately lower IOP, postponing the need for surgical intervention.

DESIGN

A prospective 90 day, multi-centered, placebo-controlled, doublemasked parallel study.

PATIENTS

We enrolled 174 glaucoma patients with inadequate IOP control on maximally tolerated medical therapy. All were candidates for either laser trabeculoplasty or invasive surgical intervention. We enrolled only one eye per patient.

INTERVENTIONS

We continued to administer maximum-tolerated medical therapy for glaucoma. Patients took the study medication every eight hours. Study medications were either apraclonidine hydrochloride 0.5% or placebo (apraclonidine's vehicle).

MAJOR OUTCOME MEASURES

We evaluated IOP, IOP change from baseline, and the number of eyes requiring surgery after the addition of study medication.

RESULTS

Sixty one percent of patients treated with apraclonidine maintained adequate IOP control throughout the study, avoiding additional surgery compared to 33.9% patients treated with placebo (P < .001). Apraclonidine treatment resulted in significantly more patients achieving either an additional > or = 20% reduction in IOP from baseline (resulting in an IOP < or = 20 mm Hg) (P < 0.05). The most common ocular complications were conjunctival hyperemia (12.6%), itching and foreign body sensation (6.8%), and tearing (4.5%). The most frequent non-ocular adverse events related to apraclonidine were dry mouth (4.5%) and unusual taste perception (2.2%).

CONCLUSIONS

Apraclonidine appears safe and efficacious. It significantly lowered IOP when used in combination with a patient's maximum tolerated medical therapy. This delayed or prevented further glaucoma surgery for at least 90 days in approximately 60% of treated patients.