title: Comparison of Latanoprostene Bunod 0.024% and Timolol Maleate 0.5% in Open-Angle Glaucoma or Ocular Hypertension: The LUNAR Study.
abstract: OBJECTIVE
  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).
  
  
  METHODS
  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.
authors.affiliation: Hamilton Glaucoma Center and Shiley Eye Institute and Department of Ophthalmology, University of California San Diego, La Jolla, California. Electronic address: fmedeiros@ucsd.edu.
authors.forename: Felipe A
authors.initials: FA
authors.lastname: Medeiros
authors.affiliation: Eye Department, Addenbrooke's Hospital and Cambridge NIHR Biomedical Research Centre, Cambridge, United Kingdom.
authors.forename: Keith R
authors.initials: KR
authors.lastname: Martin
authors.affiliation: United Medical Research Institute, Inglewood, California.
authors.forename: James
authors.initials: J
authors.lastname: Peace
authors.affiliation: Medical Affairs, Bausch & Lomb Incorporated, Bridgewater, New Jersey.
authors.forename: Baldo
authors.initials: B
authors.lastname: Scassellati Sforzolini
authors.affiliation: Clinical Affairs, Bausch & Lomb Incorporated, Bridgewater, New Jersey.
authors.forename: Jason L
authors.initials: JL
authors.lastname: Vittitow
authors.affiliation: Hamilton Glaucoma Center and Shiley Eye Institute and Department of Ophthalmology, University of California San Diego, La Jolla, California.
authors.forename: Robert N
authors.initials: RN
authors.lastname: Weinreb
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005902:Glaucoma, Open-Angle / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D007429:Intraocular Pressure / Q000502:physiology; D008297:Male; D008875:Middle Aged; D009798:Ocular Hypertension / Q000188:drug therapy* / Q000503:physiopathology; D009883:Ophthalmic Solutions / Q000627:therapeutic use; D011446:Prospective Studies; D011461:Prostaglandins F, Synthetic / Q000627:therapeutic use*; D013999:Timolol; D014792:Visual Acuity / Q000502:physiology; D055815:Young Adult
chemical_list: D000959:Antihypertensive Agents; C568859:BOL 303259-X; D009883:Ophthalmic Solutions; D011461:Prostaglandins F, Synthetic; D013999:Timolol