Randomized trial comparing three fixed combinations of prostaglandins/prostamide with timolol maleate

Abstract

Jaime Pablo Kelly Rigollet, Joan Anton Ondategui, Angels Pasto, Laura Lop, Institut Català de la Salut, Centre de Atenció Primària MANSO, Eixample esquerra, Barcelona, Spain, The results of this were first presented in the World Glaucoma Congress, Boston (8–11 July 2009)Introduction: To evaluate the long-term efficacy and safety of 3 commercially available fixed combinations of prostaglandin analogs or a prostamide with timolol maleate in patients with primary open angle glaucoma or ocular hypertension.Methods: In this randomized, prospective, single-blind study, intraocular pressure (IOP) was measured after a 1-month washout period and pachymetry was performed before randomizing patients to latanoprost 50 µg/timolol 5 mg/1 mL (L/T), bimatoprost 300 µg/timolol 5 mg/1 mL (B/T), or travoprost 40 µg/timolol 5 mg/1 mL (T/T). IOP was measured monthly for 6 months and then at 12 months by an investigator blinded to the study drug. Adverse reactions were recorded.Results: 128 cases were included in the study. The 3 treatment groups had similar baseline characteristics and comparable IOP. All 3 combinations decreased IOP by at least 6 mmHg and IOP remained below 21 mmHg throughout the study. At 12 months L/T achieved greater reduction in IOP than the other 2 fixed combinations, but the difference between L/T and B/T was not statistically significant. At 6 months, more B/T-treated patients reported red eye (P < 0.05 vs L/T and T/T). At 12 months, fewer adverse reactions were reported, with no cases of red eye reported for L/T (P = 0.03 vs B/T).Conclusions: All 3 combinations are effective at lowering IOP but at 12 months L/T and B/T were found to be more effective than T/T. Treatments were well tolerated after 12 months but L/T showed less hyperemia than B/T throughout the study (P < 0.05).Keywords: bimatoprost/timolol, fixed combinations, intraocular pressure, latanoprost/timolol, ocular hypertension, primary open angle glaucoma, travoprost/timolol.