title: A randomised, controlled comparison of latanoprostene bunod and latanoprost 0.005% in the treatment of ocular hypertension and open angle glaucoma: the VOYAGER study.
abstract: OBJECTIVE
  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.
  
  
  BACKGROUND
  NCT01223378.
authors.affiliation: Hamilton Glaucoma Center and Department of Ophthalmology, Shiley Eye Center University of California San Diego, La Jolla, California, USA.
authors.forename: Robert N
authors.initials: RN
authors.lastname: Weinreb
authors.affiliation: Bausch + Lomb, Bridgewater, New Jersey, USA.
authors.forename: Tuyen
authors.initials: T
authors.lastname: Ong
authors.affiliation: Bausch + Lomb, Bridgewater, New Jersey, USA.
authors.forename: Baldo
authors.initials: B
authors.lastname: Scassellati Sforzolini
authors.affiliation: Bausch + Lomb, Bridgewater, New Jersey, USA.
authors.forename: Jason L
authors.initials: JL
authors.lastname: Vittitow
authors.affiliation: Department of Ophthalmology, Stanford University School of Medicine, Palo Alto, California, USA.
authors.forename: Kuldev
authors.initials: K
authors.lastname: Singh
authors.affiliation: Department of Ophthalmology and Visual Sciences, University of Wisconsin, Madison, Wisconsin, USA.
authors.forename: Paul L
authors.initials: PL
authors.lastname: Kaufman
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000959:Antihypertensive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005902:Glaucoma, Open-Angle / Q000188:drug therapy*; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects*; D000077338:Latanoprost; D008297:Male; D008875:Middle Aged; D009798:Ocular Hypertension / Q000188:drug therapy*; D009883:Ophthalmic Solutions; D011461:Prostaglandins F, Synthetic / Q000008:administration & dosage* / Q000009:adverse effects; D014065:Tonometry, Ocular; D014792:Visual Acuity / Q000502:physiology; D055815:Young Adult
chemical_list: D000959:Antihypertensive Agents; C568859:BOL 303259-X; D009883:Ophthalmic Solutions; D011461:Prostaglandins F, Synthetic; D000077338:Latanoprost
keywords: Clinical Trial; Drugs; Glaucoma; Intraocular pressure; Treatment Medical