Felipe A Medeiros1, Keith R Martin2, James Peace3, Baldo Scassellati Sforzolini4, Jason L Vittitow5, Robert N Weinreb6. 1. Hamilton Glaucoma Center and Shiley Eye Institute and Department of Ophthalmology, University of California San Diego, La Jolla, California. Electronic address: fmedeiros@ucsd.edu. 2. Eye Department, Addenbrooke's Hospital and Cambridge NIHR Biomedical Research Centre, Cambridge, United Kingdom. 3. United Medical Research Institute, Inglewood, California. 4. Medical Affairs, Bausch & Lomb Incorporated, Bridgewater, New Jersey. 5. Clinical Affairs, Bausch & Lomb Incorporated, Bridgewater, New Jersey. 6. Hamilton Glaucoma Center and Shiley Eye Institute and Department of Ophthalmology, University of California San Diego, La Jolla, California.
Abstract
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.
RCT Entities:
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.
Authors: Francesco Impagnatiello; Elena Bastia; Nicoletta Almirante; Stefania Brambilla; Brigitte Duquesroix; Angela C Kothe; Michael V W Bergamini Journal: Br J Pharmacol Date: 2018-05-24 Impact factor: 8.739
Authors: Ester Reina-Torres; Michael L De Ieso; Louis R Pasquale; Michael Madekurozwa; Joseph van Batenburg-Sherwood; Darryl R Overby; W Daniel Stamer Journal: Prog Retin Eye Res Date: 2020-11-28 Impact factor: 21.198
Authors: Thomas R Walters; Angela C Kothe; José L Boyer; Dale W Usner; Krisol Lopez; Brigitte Duquesroix; Robert D Fechtner; Tomas Navratil Journal: J Glaucoma Date: 2022-04-06 Impact factor: 2.290