Abstract
Purpose::
The purpose of this study was to compare the IOP-lowering efficacy and clinical success rates of brimonidine Purite 0.15% with dorzolamide 2% as adjunctive therapy with latanoprost.
Methods::
Three month, investigator-masked, multi-center, randomized clinical trial. Patients (n=70) with open-angle glaucoma or ocular hypertension and an IOP ≥16 mm Hg after at least 6 weeks of latanoprost monotherapy were randomized to receive either brimonidine Purite 0.15% BID or dorzolamide 2% BID as adjunctive therapy for 3 months. Patients instilled study medications at 8AM and 8:15 PM. Latanoprost was instilled at 8PM. Patients did not instill their morning dose of study medication on the morning of their study visits. IOP was measured before instillation of the morning dose (trough effect) and 2 hours after instillation (peak effect). At the final study visit, the investigator completed a clinical success evaluation. Patients were judged to be clinically successful if the investigator recommended that the patient continue their assigned adjunctive treatment regimen.
Results::
In an interim analysis of 40 patients, there was no significant between- group difference in IOP at the latanoprost-treated baseline (20.7 mm Hg with brimonidine Purite and 21.2 mm Hg with dorzolamide, P=.557). After 3 months, the additional mean IOP lowering provided by brimonidine Purite at peak effect was 6.0 mm Hg (28.4%), compared with 4.6 mm Hg (21.9%) with dorzolamide (P=.167). Both regimens provided comparable additional IOP-lowering from the latanoprost-treated baseline at trough (2.7 mm Hg, 12.9% with brimonidine Purite and 2.9 mm Hg, 13.2% with dorzolamide, P=.810). As evaluated by the masked investigators, brimonidine Purite-treated patients were more likely to be clinically successful than dorzolamide-treated patients (79% versus 50%, respectively, P=.070).
Conclusions::
The addition of brimonidine Purite to latanoprost provided greater additional IOP lowering than dorzolamide. Brimonidine Purite-treated patients were more likely to be clinically successful than dorzolamide-treated patients.
Clinical Trial::
www.clinicaltrials.gov NCT00348400
Keywords: clinical (human) or epidemiologic studies: biostatistics/epidemiology methodology • clinical (human) or epidemiologic studies: outcomes/complications • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials