155
Views
36
CrossRef citations to date
0
Altmetric
Original Research

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

, , , , , & show all
Pages 1921-1929 | Published online: 02 Oct 2018

References

  • BronAJde PaivaCSChauhanSKTFOS DEWS II pathophysiology reportOcul Surf201715343851028736340
  • SternMESchaumburgCSPflugfelderSCDry eye as a mucosal autoimmune diseaseInt Rev Immunol2013321194123360156
  • CraigJPNicholsKKAkpekEKTFOS DEWS II Definition and Classification ReportOcul Surf201715327628328736335
  • StapletonFAlvesMBunyaVYTFOS DEWS II Epidemiology ReportOcul Surf201715333436528736337
  • SchaumbergDADanaRBuringJESullivanDAPrevalence of dry eye disease among US men: estimates from the Physicians’ Health StudiesArch Ophthalmol2009127676376819506195
  • SchaumbergDASullivanDABuringJEDanaMRPrevalence of dry eye syndrome among US womenAm J Ophthalmol2003136231832612888056
  • DingJSullivanDAAging and dry eye diseaseExp Gerontol201247748349022569356
  • JonesLDownieLEKorbDTFOS DEWS II Management and Therapy ReportOcul Surf201715357562828736343
  • PflugfelderSCAntiinflammatory therapy for dry eyeAm J Ophthalmol2004137233734214962426
  • FrumanDAKleeCBBiererBEBurakoffSJCalcineurin phosphatase activity in T lymphocytes is inhibited by FK 506 and cyclosporin AProc Natl Acad Sci U S A1992899368636901373887
  • SallKStevensonODMundorfTKReisBLTwo multicenter, randomized studies of the efficacy and safety of cyclosporine ophthalmic emulsion in moderate to severe dry eye disease. CsA Phase 3 Study GroupOphthalmology2000107463163910768324
  • BaudouinCFigueiredoFCMessmerEMA randomized study of the efficacy and safety of 0.1% cyclosporine A cationic emulsion in treatment of moderate to severe dry eyeEur J Ophthalmol201727552053028362054
  • LeonardiAvan SettenGAmraneMEfficacy and safety of 0.1% cyclosporine A cationic emulsion in the treatment of severe dry eye disease: a multicenter randomized trialEur J Ophthalmol201626428729627055414
  • KunertKSTisdaleASSternMESmithJAGipsonIKAnalysis of topical cyclosporine treatment of patients with dry eye syndrome: effect on conjunctival lymphocytesArch Ophthalmol2000118111489149611074805
  • KunertKSTisdaleASGipsonIKGoblet cell numbers and epithelial proliferation in the conjunctiva of patients with dry eye syndrome treated with cyclosporineArch Ophthalmol2002120333033711879137
  • Restasis [package insert]Irvine, CAAllergan2013
  • SchaumbergDAGulatiAMathersWDDevelopment and validation of a short global dry eye symptom indexOcul Surf200751505717252166
  • LempMAReport of the National Eye Institute/Industry workshop on Clinical Trials in Dry EyesClao J19952142212328565190
  • RolandoMBarabinoSMingariCDistribution of conjunctival HLA-DR expression and the pathogenesis of damage in early dry eyesCornea200524895195416227839
  • BegleyCGChalmersRLAbetzLThe relationship between habitual patient-reported symptoms and clinical signs among patients with dry eye of varying severityInvest Ophthalmol Vis Sci200344114753476114578396
  • LallemandFSchmittMBourgesJLCyclosporine A delivery to the eye: A comprehensive review of academic and industrial effortsEur J Pharm Biopharm2017117142828315447
  • VaishyaRDKhuranaVPatelSMitraAKControlled ocular drug delivery with nanomicellesWiley Interdiscip Rev Nanomed Nanobiotechnol20146542243724888969