Comparison of Latanoprostene Bunod 0.024% and Timolol Maleate 0.5% in Open-Angle Glaucoma or Ocular Hypertension: The LUNAR Study.

Published

Journal Article

PURPOSE: To compare the intraocular pressure (IOP)-lowering effect of latanoprostene bunod (LBN) 0.024% with timolol maleate 0.5% in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT). DESIGN: Prospective, randomized, double-masked, parallel-group, noninferiority clinical trial. METHODS: Adults with OAG or OHT from 46 clinical sites (United States and European Union) were randomized 2:1 to LBN instilled once daily (QD) in the evening and vehicle in the morning or timolol instilled twice a day (BID) for 3 months. IOP was measured at week 2, week 6, and month 3 (8 AM, 12 PM, and 4 PM each visit). RESULTS: A total of 387 subjects (LBN, n = 259; timolol, n = 128) completed the study. Analysis of covariance showed that mean IOP reduction with LBN was not only noninferior to timolol but significantly greater (P ≤ .025) than timolol at all but the first time point in this study (week 2, 8 AM). Of LBN- and timolol-treated subjects, respectively, 31.0% and 18.5% (P = .007) had their IOP reduced ≥25% from baseline, and 17.7% and 11.1% (P = .084) had their IOP reduced to ≤18 mm Hg over all time points/visits in this study. Ocular treatment-emergent adverse events, while uncommon, appeared more frequently in the LBN group (all mild-moderate except 1 case of severe hyperemia). CONCLUSIONS: LBN 0.024% QD in the evening was noninferior to timolol 0.5% BID over 3 months of treatment, with significantly greater IOP lowering in subjects with OAG or OHT at all but the earliest time point evaluated, and demonstrated a good safety profile.

Full Text

Duke Authors

Cited Authors

  • Medeiros, FA; Martin, KR; Peace, J; Scassellati Sforzolini, B; Vittitow, JL; Weinreb, RN

Published Date

  • August 2016

Published In

Volume / Issue

  • 168 /

Start / End Page

  • 250 - 259

PubMed ID

  • 27210275

Pubmed Central ID

  • 27210275

Electronic International Standard Serial Number (EISSN)

  • 1879-1891

Digital Object Identifier (DOI)

  • 10.1016/j.ajo.2016.05.012

Language

  • eng

Conference Location

  • United States