A randomised, controlled comparison of latanoprostene bunod and latanoprost 0.005% in the treatment of ocular hypertension and open angle glaucoma: the VOYAGER study.

Published

Journal Article

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.

Full Text

Duke Authors

Cited Authors

  • Weinreb, RN; Ong, T; Scassellati Sforzolini, B; Vittitow, JL; Singh, K; Kaufman, PL; VOYAGER study group,

Published Date

  • June 2015

Published In

Volume / Issue

  • 99 / 6

Start / End Page

  • 738 - 745

PubMed ID

  • 25488946

Pubmed Central ID

  • 25488946

Electronic International Standard Serial Number (EISSN)

  • 1468-2079

Digital Object Identifier (DOI)

  • 10.1136/bjophthalmol-2014-305908

Language

  • eng

Conference Location

  • England