PT - JOURNAL ARTICLE AU - Robert N Weinreb AU - Tuyen Ong AU - Baldo Scassellati Sforzolini AU - Jason L Vittitow AU - Kuldev Singh AU - Paul L Kaufman TI - A randomised, controlled comparison of latanoprostene bunod and latanoprost 0.005% in the treatment of ocular hypertension and open angle glaucoma: the VOYAGER study AID - 10.1136/bjophthalmol-2014-305908 DP - 2015 Jun 01 TA - British Journal of Ophthalmology PG - 738--745 VI - 99 IP - 6 4099 - http://bjo.bmj.com/content/99/6/738.short 4100 - http://bjo.bmj.com/content/99/6/738.full SO - Br J Ophthalmol2015 Jun 01; 99 AB - Aim To assess the efficacy and safety of latanoprostene bunod (LBN) compared with latanoprost 0.005%, and to determine the optimum drug concentration(s) of LBN in reducing intraocular pressure (IOP) in subjects with open angle glaucoma or ocular hypertension.Methods Randomised, investigator-masked, parallel-group, dose-ranging study. Subjects instilled one drop of study medication in the study eye once daily each evening for 28 days and completed five study visits. The primary efficacy endpoint was the reduction in mean diurnal IOP at Day 28.Results Of the 413 subjects randomised (LBN 0.006%, n=82; LBN 0.012%, n=85; LBN 0.024%, n=83; LBN 0.040%, n=81; latanoprost, n=82), 396 subjects completed the study. Efficacy for LBN was dose-dependent reaching a plateau at 0.024%–0.040%. LBN 0.024% led to significantly greater reductions in diurnal IOP compared with latanoprost at the primary endpoint, Day 28 (p=0.005), as well as Days 7 (p=0.033) and 14 (p=0.015). The incidence of adverse events, mostly mild and transient, was numerically higher in the LBN treatment groups compared with the latanoprost group. Hyperaemia was similar across treatments.Conclusions LBN 0.024% dosed once daily was the lower of the two most effective concentrations evaluated, with significantly greater IOP lowering and comparable side effects relative to latanoprost 0.005%. LBN dosed once daily for 28 days was well tolerated.Clinical trial number NCT01223378.