Dry Eye Treatment with Topical Cyclosporine 0.1% in Chondroitin Sulfate Ophthalmic Emulsion

References

• Singla S, Sarkar L, Joshi M. Comparison of topical cyclosporine alone and topical loteprednol with cyclosporine in moderate dry eye in Indian population: a prospective study. Taiwan J Ophthalmol. 2019;9(3):173–178. doi:10.4103/tjo.tjo_15_18
   Google Scholar
• Findlay Q, Reid K. Dry eye disease: when to treat and when to refer. Aust Prescr. 2018;41(5):160–163. doi:10.18773/austprescr.2018.048
   PubMed Web of Science ®Google Scholar
• Baudouin C, Figueiredo FC, Messmer EM, et al. A randomized study of the efficacy and safety of 0.1% cyclosporine A cationic emulsion in treatment of moderate to severe dry eye. Eur J Ophthalmol. 2017;27(5):520–530. doi:10.5301/ejo.5000952
   PubMed Web of Science ®Google Scholar
• Sall K, Stevenson OD, Mundorf TK, Reis BL. Two multicenter, randomized studies of the efficacy and safety of cyclosporine ophthalmic emulsion in moderate to severe dry eye disease. CsA Phase 3 Study Group. Ophthalmology. 2000;107(4):631–639. doi:10.1016/S0161-6420(99)00176-1
   PubMed Web of Science ®Google Scholar
• Craig JP, Nichols KK, Akpek EK, et al. TFOS DEWS II definition and classification report. Ocul Surf. 2017;15(3):276–283. doi:10.1016/j.jtos.2017.05.008
   PubMed Web of Science ®Google Scholar
• Buckley RJ. Assessment and management of dry eye disease. Eye (Lond). 2018;32(2):200–203. doi:10.1038/eye.2017.289
   PubMed Web of Science ®Google Scholar
• Leonardi A, Van Setten G, Amrane M, et al. Efficacy and safety of 0.1% cyclosporine A cationic emulsion in the treatment of severe dry eye disease: a multicenter randomized trial. Eur J Ophthalmol. 2016;26(4):287–296. doi:10.5301/ejo.5000779
   PubMed Web of Science ®Google Scholar
• McGhee CN, Dean S, Danesh-Meyer H. Locally administered ocular corticosteroids: benefits and risks. Drug Saf. 2002;25(1):33–55. doi:10.2165/00002018-200225010-00004
   PubMed Web of Science ®Google Scholar
• Barber LD, Pflugfelder SC, Tauber J, Foulks GN. Phase III safety evaluation of cyclosporine 0.1% ophthalmic emulsion administered twice daily to dry eye disease patients for up to 3 years. Ophthalmology. 2005;112(10):1790–1794. doi:10.1016/j.ophtha.2005.05.013
   PubMed Web of Science ®Google Scholar
• Stevenson D, Tauber J, Reis BL. Efficacy and safety of cyclosporin A ophthalmic emulsion in the treatment of moderate-to-severe dry eye disease: a dose-ranging, randomized trial. The Cyclosporin A Phase 2 Study Group. Ophthalmology. 2000;107(5):967–974. doi:10.1016/S0161-6420(00)00035-X
   PubMed Web of Science ®Google Scholar
• Wirta DL, Torkildsen GL, Moreira HR, et al. A Clinical Phase II study to assess efficacy, safety, and tolerability of waterfree cyclosporine formulation for treatment of dry eye disease. Ophthalmology. 2019;126(6):792–800. doi:10.1016/j.ophtha.2019.01.024
   PubMed Web of Science ®Google Scholar
• Mandal A, Gote V, Pal D, Ogundele A, Mitra AK. Ocular pharmacokinetics of a topical ophthalmic nanomicellar solution of cyclosporine (Cequa(R)) for Dry Eye Disease. Pharm Res. 2019;36(2):36. doi:10.1007/s11095-018-2556-5
   PubMed Web of Science ®Google Scholar
• Pflugfelder SC. Antiinflammatory therapy for dry eye. Am J Ophthalmol. 2004;137(2):337–342. doi:10.1016/j.ajo.2003.10.036
   PubMed Web of Science ®Google Scholar
• Kim EC, Choi JS, Joo CK. A comparison of vitamin a and cyclosporine a 0.05% eye drops for treatment of dry eye syndrome. Am J Ophthalmol. 2009;147(2):206–213 e203. doi:10.1016/j.ajo.2008.08.015
   PubMed Web of Science ®Google Scholar
• Kunert KS, Tisdale AS, Gipson IK. Goblet cell numbers and epithelial proliferation in the conjunctiva of patients with dry eye syndrome treated with cyclosporine. Arch Ophthalmol. 2002;120(3):330–337. doi:10.1001/archopht.120.3.330
   PubMedGoogle Scholar
• Moon JW, Lee HJ, Shin KC, Wee WR, Lee JH, Kim MK. Short term effects of topical cyclosporine and viscoelastic on the ocular surfaces in patients with dry eye. Korean J Ophthalmol. 2007;21(4):189–194. doi:10.3341/kjo.2007.21.4.189
   PubMedGoogle Scholar
• Wilson SE, Perry HD. Long-term resolution of chronic dry eye symptoms and signs after topical cyclosporine treatment. Ophthalmology. 2007;114(1):76–79. doi:10.1016/j.ophtha.2006.05.077
   PubMed Web of Science ®Google Scholar
• Zhou XQ, Wei RL. Topical cyclosporine A in the treatment of dry eye: a systematic review and meta-analysis. Cornea. 2014;33(7):760–767. doi:10.1097/ICO.0000000000000123
   PubMed Web of Science ®Google Scholar
• Baiza-Duran L, Medrano-Palafox J, Hernandez-Quintela E, Lozano-Alcazar J, Alaniz-de la OJ. A comparative clinical trial of the efficacy of two different aqueous solutions of cyclosporine for the treatment of moderate-to-severe dry eye syndrome. Br J Ophthalmol. 2010;94(10):1312–1315. doi:10.1136/bjo.2008.150011
   PubMed Web of Science ®Google Scholar
• Lallemand F, Schmitt M, Bourges JL, Gurny R, Benita S, Garrigue JS. Cyclosporine A delivery to the eye: a comprehensive review of academic and industrial efforts. Eur J Pharm Biopharm. 2017;117:14–28. doi:10.1016/j.ejpb.2017.03.006
   PubMed Web of Science ®Google Scholar
• Schiffman RM, Christianson MD, Jacobsen G, Hirsch JD, Reis BL. Reliability and validity of the ocular surface disease index. Arch Ophthalmol. 2000;118(5):615–621. doi:10.1001/archopht.118.5.615
   PubMedGoogle Scholar
• Lemp MA. Report of the national eye institute/Industry workshop on clinical trials in dry eyes. CLAO J. 1995;21(4):221–232.
   PubMedGoogle Scholar
• Jones L, Downie LE, Korb D, et al. TFOS DEWS II management and therapy report. Ocul Surf. 2017;15(3):575–628.
   PubMed Web of Science ®Google Scholar
• Ridder III WH, Karsolia A. New drugs for the treatment of dry eye disease. Clin Optom (Auckl). 2015;7:91–102. doi:10.2147/OPTO.S68271
   Google Scholar
• Tatlipinar S, Akpek EK. Topical ciclosporin in the treatment of ocular surface disorders. Br J Ophthalmol. 2005;89(10):1363–1367. doi:10.1136/bjo.2005.070888
   PubMed Web of Science ®Google Scholar
• Stonecipher K, Perry HD, Gross RH, Kerney DL. The impact of topical cyclosporine A emulsion 0.05% on the outcomes of patients with keratoconjunctivitis sicca. Curr Med Res Opin. 2005;21(7):1057–1063. doi:10.1185/030079905X50615
   PubMed Web of Science ®Google Scholar
• Dastjerdi MH, Hamrah P, Dana R. High-frequency topical cyclosporine 0.05% in the treatment of severe dry eye refractory to twice-daily regimen. Cornea. 2009;28(10):1091–1096. doi:10.1097/ICO.0b013e3181a16472
   PubMed Web of Science ®Google Scholar
• Tauber J, Schechter BA, Bacharach J, et al. A Phase II/III, randomized, double-masked, vehicle-controlled, dose-ranging study of the safety and efficacy of OTX-101 in the treatment of dry eye disease. Clin Ophthalmol. 2018;12:1921–1929. doi:10.2147/OPTH.S175065
   PubMed Web of Science ®Google Scholar
• Baudouin C, de la Maza MS, Amrane M, et al. One-year efficacy and safety of 0.1% Cyclosporine a cationic emulsion in the treatment of severe dry eye disease. Eur J Ophthalmol. 2017;27(6):678–685. doi:10.5301/ejo.5001002
   PubMed Web of Science ®Google Scholar
• Luchs J. Phase 3 clinical results of cyclosporine 0.09% in a new nanomicellar ophthalmic solution to treatment keratoconjunctivitis sicca. Paper presented at: American society of cataract and refractive surgery (ASCRS) annual meeting; 2018.
   Google Scholar
• Ames P, Galor A. Cyclosporine ophthalmic emulsions for the treatment of dry eye: a review of the clinical evidence. Clin Investig (Lond). 2015;5(3):267–285. doi:10.4155/cli.14.135
   Google Scholar
• Mah F, Milner M, Yiu S, Donnenfeld E, Conway TM, Hollander DA. PERSIST: physician’s Evaluation of Restasis((R)) Satisfaction in Second Trial of topical cyclosporine ophthalmic emulsion 0.05% for dry eye: a retrospective review. Clin Ophthalmol. 2012;6:1971–1976. doi:10.2147/OPTH.S30261
   PubMedGoogle Scholar
• Coursey TG, Wassel RA, Quiambao AB, Farjo RA. Once-daily cyclosporine-A-MiDROPS for treatment of dry eye disease. Transl Vis Sci Technol. 2018;7(5):24. doi:10.1167/tvst.7.5.24
   Web of Science ®Google Scholar
• Gore A, Attar M, Pujara C, Neervannan S. Ocular emulsions and dry eye: a case study of a non-biological complex drug product delivered to a complex organ to treat a complex disease. Generic Biosimilar Initiative J. 2017;6(1):13–23. doi:10.5639/gabij.2017.0601.004
   Google Scholar
• Food and Drug Administration. Restasis (cyclosporine) ophthalmic label. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050790s020lbl.pdf. Accessed February 11, 2021.
   Google Scholar
• Limberg MB, McCaa C, Kissling GE, Kaufman HE. Topical application of hyaluronic acid and chondroitin sulfate in the treatment of dry eyes. Am J Ophthalmol. 1987;103(2):194–197. doi:10.1016/S0002-9394(14)74226-6
   PubMed Web of Science ®Google Scholar
• Llamas-Moreno JF, Baiza-Duran LM, Saucedo-Rodriguez LR, Alaniz-de la OJ. Efficacy and safety of chondroitin sulfate/xanthan gum versus polyethylene glycol/propylene glycol/hydroxypropyl guar in patients with dry eye. Clin Ophthalmol. 2013;7:995–999. doi:10.2147/OPTH.S46337
   PubMedGoogle Scholar
• Lindstrom RL, Kaufman HE, Skelnik DL, et al. Optisol corneal storage medium. Am J Ophthalmol. 1992;114(3):345–356. doi:10.1016/S0002-9394(14)71803-3
   Web of Science ®Google Scholar