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PURPOSE: To evaluate the efficacy and safety of the timolol maleate/latanoprost fixed combination (TLFC) given once each evening versus brimonidine and timolol solution given twice daily as concomitant therapy in primary open-angle glaucoma or ocular hypertension patients. METHODS: Qualified subjects were begun on timolol alone twice daily for one month and then randomized to either TLFC or brimonidine and timolol concomitant therapy for six weeks. Patients were then switched to the other treatment regimen. Intraocular pressure (IOP) was measured every two hours between 08:00 and 20:00 hours at baseline and at the end of periods 1 and 2. RESULTS: This study found that, in 32 subjects, the IOP diurnal curve on timolol alone (20.9 ± 2.8 mmHg) decreased to 17.9 ± 3.2 mmHg when patients were treated with TLFC and to 19.0 ± 2.4 mmHg when patients were treated with brimonidine and timolol (p = 0.02). IOPs at individual time-points were statistically similar between the groups at the 08:00 trough, and two and four hours after dosing. However, beyond four hours after dosing, TLFC-treated subjects demonstrated a trend towards a lower IOP at each two-hour time-point, which was not statistically significant after a Bonferroni correction (p ≤ 0.05). The incidence of both solicited and unsolicited side-effects was similar between groups. CONCLUSIONS: This study suggests that TLFC given in the evening reduces the mean daytime diurnal IOP more than brimonidine and timolol given concomitantly twice daily.
Dr. W.C. Stewart, Pharmaceutical Research Network, LLC, 1639 Tatum Street, Charleston, SC 29412-2464, USA
11.3.3 Apraclonidine, brimonidine (Part of: 11 Medical treatment > 11.3 Adrenergic drugs)
11.4 Prostaglandins (Part of: 11 Medical treatment)