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

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).