223
Views
0
CrossRef citations to date
0
Altmetric
CLINICAL TRIAL REPORT

Preservative-Free versus Benzalkonium Chloride–Preserved Latanoprost Ophthalmic Solution in Patients with Primary Open-Angle Glaucoma or Ocular Hypertension: A Phase 3 US Clinical Trial

, , , ORCID Icon, & ORCID Icon
Pages 2575-2588 | Received 29 Mar 2023, Accepted 18 Aug 2023, Published online: 01 Sep 2023

References

  • Tham Y-C, Li X, Wong TY, Quigley HA, Aung T, Cheng C-Y. Global prevalence of glaucoma and projections of glaucoma burden through 2040: a systematic review and meta-analysis. Ophthalmology. 2014;121(11):2081–2090. doi:10.1016/j.ophtha.2014.05.013
  • Allison K, Patel D, Alabi O. Epidemiology of glaucoma: the past, present, and predictions for the future. Cureus. 2020;12(11):e11686. doi:10.7759/cureus.11686
  • Weinreb RN, Aung T, Medeiros FA. The pathophysiology and treatment of glaucoma: a review. JAMA. 2014;311(18):1901–1911. doi:10.1001/jama.2014.3192
  • Musch DC, Gillespie BW, Lichter PR, Niziol LM, Janz NK, CIGTS Study Investigators. Visual field progression in the Collaborative Initial Glaucoma Treatment Study: The impact of treatment and other baseline factors. Ophthalmology. 2009;116(2):200–207. doi:10.1016/j.ophtha.2008.08.051
  • Nouri-Mahdavi K, Hoffman D, Coleman AL, et al. Predictive factors for glaucomatous visual field progression in the Advanced Glaucoma Intervention Study. Ophthalmology. 2004;111(9):1627–1635. doi:10.1016/j.ophtha.2004.02.017
  • Leske MC, Heijl A, Hussein M, et al. Factors for glaucoma progression and the effect of treatment: the early manifest glaucoma trial. Arch Ophthalmol. 2003;121(1):48–56. doi:10.1001/archopht.121.1.48
  • Gedde SJ, Vinod K, Wright MM, et al. Primary Open-Angle Glaucoma Preferred Practice Pattern®. Ophthalmology. 2021;128(1):71–P150. doi:10.1016/j.ophtha.2020.10.022
  • Baudouin C, Labbe A, Liang H, Pauly A, Brignole-Baudouin F. Preservatives in eyedrops: the good, the bad and the ugly. Prog Retin Eye Res. 2010;29(4):312–334. doi:10.1016/j.preteyeres.2010.03.001
  • Brunner J, Ragupathy S, Borchard G. Target specific tight junction modulators. Adv Drug Deliv Rev. 2021;171:266–288. doi:10.1016/j.addr.2021.02.008
  • Burstein NL. Preservative alteration of corneal permeability in humans and rabbits. Invest Ophthalmol Vis Sci. 1984;25(12):1453–1457.
  • Majumdar S, Hippalgaonkar K, Repka MA. Effect of chitosan, benzalkonium chloride and ethylenediaminetetraacetic acid on permeation of acyclovir across isolated rabbit cornea. Int J Pharm. 2008;348(1–2):175–178. doi:10.1016/j.ijpharm.2007.08.017
  • Okabe K, Kimura H, Okabe J, et al. Effect of benzalkonium chloride on transscleral drug delivery. Invest Ophthalmol Vis Sci. 2005;46(2):703–708. doi:10.1167/iovs.03-0934
  • Leung EW, Medeiros FA, Weinreb RN. Prevalence of ocular surface disease in glaucoma patients. J Glaucoma. 2008;17(5):350–355. doi:10.1097/IJG.0b013e31815c5f4f
  • Harasymowycz P, Hutnik C, Rouland JF, et al. Preserved versus preservative-free latanoprost for the treatment of glaucoma and ocular hypertension: a post hoc pooled analysis. Adv Ther. 2021;38(6):3019–3031. doi:10.1007/s12325-021-01731-9
  • Thygesen J. Glaucoma therapy: preservative-free for all? Clin Ophthalmol. 2018;12:707–717. doi:10.2147/OPTH.S150816
  • Stalmans I, Lemij H, Clarke J, Baudouin C. Signs and symptoms of ocular surface disease: the reasons for patient dissatisfaction with glaucoma treatments. Clin Ophthalmol. 2020;14:3675–3680. doi:10.2147/opth.S269586
  • Alm A. Latanoprost in the treatment of glaucoma. Clin Ophthalmol. 2014;8:1967–1985. doi:10.2147/OPTH.S59162
  • Baudouin C, Renard JP, Nordmann JP, et al. Prevalence and risk factors for ocular surface disease among patients treated over the long term for glaucoma or ocular hypertension. Eur J Ophthalmol. 2012:1:56. doi:10.5301/ejo.5000181
  • Wolfram C, Stahlberg E, Pfeiffer N. Patient-reported nonadherence with glaucoma therapy. J Ocul Pharmacol Ther. 2019;35(4):223–228. doi:10.1089/jop.2018.0134
  • Kastelan S, Tomic M, Metez Soldo K, Salopek-Rabatic J. How ocular surface disease impacts the glaucoma treatment outcome. Biomed Res Int. 2013;2013:696328. doi:10.1155/2013/696328
  • Thea Pharmaceuticals Ltd. Summary of Product Characteristics. MONOPOST latanoprost 50 mcg/mL eye drops, solution in single-dose container. Available from: https://www.medicines.org.uk/emc/product/2978/smpc. Accessed January 7, 2023.
  • Rouland JF, Traverso CE, Stalmans I, et al. Efficacy and safety of preservative-free latanoprost eyedrops, compared with BAK-preserved latanoprost in patients with ocular hypertension or glaucoma. Br J Ophthalmol. 2013;97(2):196–200. doi:10.1136/bjophthalmol-2012-302121
  • Muñoz Negrete FJ, Lemij HG, Erb C. Switching to preservative-free latanoprost: impact on tolerability and patient satisfaction. Clin Ophthalmol. 2017;11:557–566. doi:10.2147/opthOPTH.S126042
  • Economou MA, Laukeland HK, Grabska-Liberek I, Rouland JF. Better tolerance of preservative-free latanoprost compared to preserved glaucoma eye drops: the 12-month real-life FREE study. Clin Ophthalmol. 2018;12:2399–2407. doi:10.2147/opthOPTH.S176605
  • Denis P. Unpreserved latanoprost in the treatment of open-angle glaucoma and ocular hypertension. A multicenter, randomized, controlled study. J Fr Ophtalmol. 2016;39(7):622–630. doi:10.1016/j.jfo.2016.05.006
  • Cucherat M, Stalmans I, Rouland JF. Relative efficacy and safety of preservative-free latanoprost (T2345) for the treatment of open-angle glaucoma and ocular hypertension: an adjusted Indirect comparison meta-analysis of randomized clinical trials. J Glaucoma. 2014;23(1):e69–75. doi:10.1097/IJG.0b013e3182a075e6
  • Misiuk-Hojlo M, Pomorska M, Mulak M, et al. The RELIEF study: tolerability and efficacy of preservative-free latanoprost in the treatment of glaucoma or ocular hypertension. Eur J Ophthalmol. 2019;29(2):210–215. doi:10.1177/1120672118785280
  • Shen Lee B, Malhotra R, Sall K, Mitchell B, Peace J. Open-label extension study comparing latanoprost 0.005% without vs with benzalkonium chloride in open-angle glaucoma or ocular hypertension. Clin Ophthalmol. 2022;16:2285–2293. doi:10.2147/opth.S367756
  • American Academy of Ophthalmology Glaucoma Panel. Preferred Practice Pattern Guidelines. Primary Open-Angle Glaucoma. San Francisco: American Academy of Ophthalmology; 2010.
  • Wirta D, Malhotra R, Peace J, et al. Noninferiority study comparing latanoprost 0.005% without versus with benzalkonium chloride in open-angle glaucoma or ocular hypertension. Eye Contact Lens. 2022;48(4):149–154. doi:10.1097/ICL.0000000000000860
  • Camras CB. Comparison of latanoprost and timolol in patients with ocular hypertension and glaucoma: a six-month masked, multicenter trial in the United States. The United States Latanoprost Study Group. Ophthalmology. 1996;103(1):138–147. doi:10.1016/s0161-6420(96)30749-5
  • Aptel F, Choudhry R, Stalmans I. Preservative-free versus preserved latanoprost eye drops in patients with open-angle glaucoma or ocular hypertension. Curr Med Res Opin. 2016;32(8):1457–1463. doi:10.1080/03007995.2016.1202818
  • Aspberg J, Heijl A, Jóhannesson G, Lindén C, Andersson-Geimer S, Bengtsson B. Intraocular pressure lowering effect of latanoprost as first-line treatment for glaucoma. J Glaucoma. 2018;27(11):976–980. doi:10.1097/ijg.0000000000001055
  • Uusitalo H, Chen E, Pfeiffer N, et al. Switching from a preserved to a preservative-free prostaglandin preparation in topical glaucoma medication. Acta Ophthalmol. 2010;88(3):329–336. doi:10.1111/j.1755-3768.2010.01907.x
  • Fenwick EK, Man RE, Aung T, Ramulu P, Lamoureux EL. Beyond intraocular pressure: optimizing patient-reported outcomes in glaucoma. Prog Retin Eye Res. 2020;76:100801. doi:10.1016/j.preteyeres.2019.100801
  • Kardas P, Lewek P, Matyjaszczyk M. Determinants of patient adherence: a review of systematic reviews. Front Pharmacol. 2013;4:91. doi:10.3389/fphar.2013.00091
  • Skalicky SE, Goldberg I, McCluskey P. Ocular surface disease and quality of life in patients with glaucoma. Am J Ophthalmol. 2012;153(1):1–9 e2. doi:10.1016/j.ajo.2011.05.033
  • Quaranta L, Riva I, Gerardi C, Oddone F, Floriani I, Konstas AG. Quality of life in glaucoma: a review of the literature. Adv Ther. 2016;33(6):959–981. doi:10.1007/s12325-016-0333-6