Preference for a fixed combination of brinzolamide/timolol versus dorzolamide/ timolol among patients with open-angle glaucoma or ocular hypertension

Abstract

ObjectiveTo assess ocular discomfort upon instillation and patient preference for brinzolamide/timolol relative to dorzolamide/timolol, in patients with open-angle glaucoma or ocular hypertension.MethodsThis was a multicenter, prospective, patient-masked, randomized, crossover study. On day 0, patients received one drop of brinzolamide/timolol in one eye and one drop of dorzolamide/timolol in the contralateral eye. On day 1, patients were randomly assigned to receive one drop of either brinzolamide/timolol or dorzolamide/timolol in both eyes; on day 2, patients received one drop of the alternate treatment in both eyes. Measures included a patient preference question on day 2 (primary) and mean ocular discomfort scale scores on days 1 and 2 (secondary). Safety assessments included adverse events, visual acuity, and slit-lamp examinations.ResultsOf 120 patients who enrolled, 115 completed the study. Of these, 112 patients instilled both medications and expressed a study medication preference on day 2. A significantly greater percentage preferred brinzolamide/timolol to dorzolamide/timolol (67.0% versus 30.4%; P < 0.001). The ocular discomfort (expressed as mean [standard deviation]) with brinzolamide/timolol was significantly lower than with dorzolamide/timolol (day 2:1.9 [2.3] versus 3.7 [2.8], respectively [P = 0.0003]; both days combined: 2.1 [2.5] versus 3.5 [2.9], respectively [P = 0.00014]). On day 1, five patients receiving brinzolamide/timolol reported five nonserious adverse events (AEs): flu (n = 1), bitter taste (n = 2), and headache (n = 2). Four events, bitter taste (two events) and headache (two events), were considered related to brinzolamide/timolol. Events were mild in intensity, except bitter taste of moderate intensity reported by one patient. No AEs were reported at day 2. All AEs resolved without additional treatment. No clinically relevant changes from baseline were observed in best-corrected visual acuity or slit-lamp examinations of ocular signs.ConclusionPatients had less discomfort with brinzolamide/timolol than with dorzolamide/timolol, and more expressed a preference for brinzolamide/timolol. Both treatments were generally safe and well tolerated.

Efficacy and safety of brinzolamide/timolol fixed combination compared with timolol in Japanese patients with open-angle glaucoma or ocular hypertension

“…BRINZ/TIM-FC therapy was associated with significantly greater reductions in IOP compared with TIM monotherapy at the estimated peak (primary endpoint) and trough (secondary endpoint) time points, and it was well tolerated in this study population. Overall, the efficacy and safety profiles of BRINZ/TIM-FC observed in the present study were consistent with those reported in previous investigations of BRINZ/TIM-FC, BRINZ monotherapy, or concomitant BRINZ and TIM therapy in other patient populations 8,21,23,24,27,34,35. The double-masked, randomized design of this study increases the confidence in the findings presented here.…”

Safety and efficacy of a fixed versus unfixed brinzolamide/timolol combination in Japanese patients with open-angle glaucoma or ocular hypertension

“…The safety and efficacy of BRINZ/TIM-FC and BRINZ + TIM in this study were consistent with those reported in previous studies of these agents as combination therapy and monotherapy in other patient populations 10,11,18,19,21,22,30,31. Similar to the current study, which demonstrated comparable efficacy of BRINZ/TIM-FC and unfixed concomitant BRINZ + TIM, other clinical assessments of fixed-combination therapies have demonstrated that fixed-combination pharmacotherapies containing TIM and dorzolamide, a carbonic anhydrase inhibitor, or latanoprost, a prostaglandin analog, have efficacy similar to that of concomitant treatment with their active components 32–35.…”

“…However, in a previous multinational noninferiority study conducted in Europe, BRINZ/TIM-FC produced IOP reductions similar to those achieved with fixed-combination dorzolamide 2%/TIM 20. Further, studies conducted in the US and South America indicate that among patients with a treatment preference, BRINZ/TIM-FC was favored by patients over fixed-combination dorzolamide 2%/TIM 21,31. This result may be attributable to the increased severity and duration of ocular discomfort with dorzolamide 2%/TIM compared with BRINZ/TIM-FC 18,21,31,36.…”

Efficiency, safety, and patient preference of switching from dorzolamide 1%/timolol 0.5% to brinzolamide 1%/timolol 0.5% while maintaining the prostaglandin F2&alpha; analog

“…Several previous reports have compared the efficiency and safety of fixed combination therapy, including dorzolamide 2%/timolol 0.5% and brinzolamide 1%/timolol 0.5%, 10 – 17 with many authors reporting similar intraocular pressure (IOP)-lowering efficacy for these treatments. 11 , 15 , 16 …”

“…Regarding patient preferences, some reports have shown that patients prefer brinzolamide 1%/timolol 0.5% when asked an alternative question. 10 , 13 , 16 , 17 However, in clinical practice, we often hesitate over which eye drop to choose because some patients cannot tolerate brinzolamide 1%/timolol 0.5% but can tolerate dorzolamide 1%/timolol 0.5%. We suspect that patients’ real preferences cannot be judged by two selections, and in actuality some patients may be tolerant to both.…”