Área Técnica: Glaucoma
TRIPLE FIXED COMBINATION BIMATOPROST/BRIMONIDINE/TIMOLOL VERSUS DUAL FIXED COMBINATION BRIMONIDINE/TIMOLOL OPHTHALMIC SOLUTIONS IN GLAUCOMA: A MULTICENTER, RANDOMIZED, DOUBLE-MASKED STUDY
To assess the efficacy/safety of triple fixed-combination bimatoprost 0.01%/brimonidine 0.15%/timolol 0.5% (TFC) vs dual fixed-combination brimonidine 0.2%/timolol 0.5% (DFC; Combigan®, Allergan plc) in primary open-angle glaucoma (POAG) and ocular hypertension (OHT).
Patients with baseline intraocular pressure (IOP) ≥23 and ≤34 mm Hg were randomized after washout to TFC or DFC twice daily in both eyes for a primary treatment period of 12 weeks and a 9-month masked extension. Primary efficacy variable: mean worse eye IOP change from baseline (mean IOP change) at week 12 in the modified intent-to-treat (mITT) population. Superiority of TFC over DFC was declared if the treatment difference favored TFC (p≤.05, 2-sample t test). Secondary (mean IOP change and mean IOP at all visits by mixed-model repeated measure), patient/investigator-reported outcomes at week 12) and sensitivity analyses were conducted. Safety was assessed at all visits.
Baseline demographics were similar between the TFC (N=90) and DFC (N=95) groups. Superiority (2.17 mm Hg; p≤.001) of TFC over DFC was demonstrated at week 12, at all visits in all analyses in the primary treatment period (p<.001), and in the masked extension (p≤.007; N=140). At week 12, >77% of respondents in both groups were very willing/extremely willing to continue their study-assigned treatment. While as expected the incidence of treatment-related conjunctival hyperemia was greater with TFC than DFC (p=.001), TFC did not cause unexpected adverse events or raise any new safety concerns.
TFC provides a clinically and statistically significantly greater IOP lowering than DFC, and has an acceptable tolerability profile in patients with POAG or OHT and high IOP.