Aims: To evaluate the safety and IOP-lowering efficacy of Brinzolamide 1% twice daily (b.i.d.) compared to Dorzolamide 2.0% b.i.d., when used as added treatment to Timolol 0.5% b.i.d. in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OH).
Methods: 241 patients with
POAG or OH were randomized in double-blind fashion and 238 received treatment
for up to 3 months: Brinzolamide 1% b.i.d. plus Timolol 0.5% b.i.d. (n=116), or
Dorzolamide 2.0% b.i.d. plus Timolol 0.5% b.i.d. (n=122). IOPs at two visits were between 23 and
36 mmHg at 9 am, and between 21 and 36 mmHg at 11 am. On therapy, IOPs were measured at 9 am (trough effect, 12
hours post-dose) and 11 am (peak effect, 2 hours post-dose) at months 1, 2, and
3.
Results: Brinzolamide 1%
produced clinically relevant and statistically significant changes in IOP (-3.6
to -5.3 mmHg) which were equivalent to Dorzolamide 2.0% (-3.6 to –5.1 mmHg),
when used in addition to Timolol 0.5%.
Brinzolamide 1% is safe and well tolerated producing a lower incidence
of ocular discomfort than Dorzolamide 2.0%.
Conclusions: IOP reductions with Brinzolamide 1%
b.i.d. and Dorzolamide 2.0% b.i.d. were both clinically and statistically
equivalent when used with Timolol b.i.d.
Brinzolamide 1% is a safe, well tolerated and efficacious topical ocular
therapy when used in addition to Timolol for the reduction of elevated IOP
associated with POAG and OH.