The safety and efficacy of brinzolamide 1%/timolol 0.5% fixed combination versus dorzolamide 2%/timolol 0.5% in patients with open-angle glaucoma or ocular hypertension.

Purpose: The aim of this study was to compare the intraocular pressure (IOP) lowering efficacy and to determine patient preference based on ocular discomfort with fixed combination brinzolamide/timolol and fixed combination dorzolamide/timolol in patients with open-angle glaucoma or ocular hypertension who required a change in therapy due to elevated IOP while receiving IOP-lowering medication.

Methods: This was a 3-month, randomized, double-blinded, active-controlled, parallel-group trial. Patients had open-angle glaucoma or ocular hypertension, which could not be controlled with monotherapy and were randomized to twice daily therapy with either brinzolamide 1%/timolol 0.5% or dorzolamide 2%/timolol 0.5%. IOP assessments were taken at 8 AM, 10 AM, and 4 PM at week 2 as well as at months 1, 2, and 3. Patients completed ocular discomfort assessments (based on stinging, burning, feeling of heat or warmth, or sharp pain) on their current IOP lowering therapy at baseline.

Results: Of the 114 patients enrolled, 57 received Brinz/Tim and 57 received Dorz/Tim twice daily. Both medications produced statistically relevant IOP reductions, which were similar in both groups at each visit. The IOP reductions with Brinz/Tim ranged from 6.42 to 9.74 mmHg (26.09%-37.46%), whereas Dorz/Tim produced mean IOP reductions ranging from 8.16 to 12.41 mmHg (31.19%-41.44%) (P>0.05). Brinz/Tim showed significantly less ocular irritation (0.5% vs. 15.7%, respectively; P=0.0004) than Dorz/Tim.

Conclusions: Both Brinz/Tim and Dorz/Tim showed similar significant and clinically relevant IOP-lowering efficacy, whereas Brinz/Tim provided superior outcomes in terms of ocular comfort.