Purpose: To compare the therapeutic efficacy and safety of brimonidine/timolol fixed-combination (BTFC) and 0.5 % timolol ophthalmic solution in normal-tension glaucoma (NTG) patients. Methods: This was a multi-institution, randomized, active-controlled, open-label, parallel-group study. After a full ophthalmic and glaucoma examination, a total of 110 NTG patients—55 undergoing therapy with BTFC and 55 0.5 %, with timolol—participated in this study. Among them, 1 failed to meet the inclusion/exclusion criteria, 10 revoked their consent to participate in the study, 3 had adverse reactions, and 1 had a drug adherence rate of less than 70 %. Ultimately, a total of 95 patients—48 in the BTFC group and 47 in the 0.5 % timolol group—completed the study. The study visits took place at baseline and at 4 and 12 weeks. Diurnal IOP was measured at 9 a.m., 11 a.m., and 5 p.m. during the baseline visit and the visit at 12 weeks after eye-drop instillation. At each follow-up visit, compliance was assessed. Throughout the study, all adverse events were recorded and monitored by the investigators. Results: The average difference in IOP change measured at 11 a.m. 12 weeks after administration between the two groups was 2.10 ± 2.59 mmHg. The BTFC group had a better IOP-lowering effect at all time points than did the 0.5 % timolol group. The ratio of patients whose average IOP had decreased by >20 % after 4 and 12 weeks was 50 and 56 % in the BTFC group, respectively, whereas it was 29.41 and 23.53 % in the 0.5 % timolol group, respectively (p = 0.034, <0.001). Conclusions: BTFC has a superior IOP-lowering effect than 0.5 % timolol in NTG patients.
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© 2015, Japanese Ophthalmological Society.
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