title: Effect of loteprednol etabonate 0.5% on initiation of dry eye treatment with topical cyclosporine 0.05%.
abstract: OBJECTIVE
  The purpose of this work was to evaluate the effect of loteprednol etabonate (LE) before the initiation of topical cyclosporine A (tCsA) therapy in patients with mild-to-moderate dry eye disease. Prospective, multicenter randomized double-masked parallel group clinical study (NCT00407043).
  
  
  METHODS
  Hundred and eighteen patients with dry eye disease were randomized to receive either LE and tCsA (n=61) or artificial tears (AT) and tCsA (n=57). Hundred and twelve patients completed the study (LE: n=57, AT: n=55) and are included in the data analysis. Patients self-administered either LE or AT for 2 weeks 4 times per day, followed by tCsA twice per day accompanied by either LE twice per day or AT twice per day for an additional 6 weeks of treatment. Primary outcome measures included the Ocular Surface Disease Index (OSDI) questionnaire, the Likert scale using standardized facial expressions, lissamine green staining, fluorescein staining, and the Schirmer test. Additional measures included global self-assessment, and safety outcomes included slitlamp examination, intraocular pressure, and assessment of visual acuity.
  
  
  RESULTS
  Loteprednol etabonate pretreatment significantly reduced tCsA stinging (P<0.05). Both groups showed significantly improved OSDI scores at the 14-, 30-, and 60-day visits. Loteprednol etabonate showed significantly more OSDI improvement than AT. Both pretreatment strategies improved global self-assessment scores, Schirmer test, fluorescein staining, lissamine staining, and adjunctive AT use. Loteprednol etabonate showed superior improvement in Schirmer test, fluorescein staining, and lissamine staining. Intraocular pressure did not increase in either group.
  
  
  CONCLUSIONS
  Loteprednol etabonate induction therapy 2 weeks before the initiation of long-term tCsA treatment for chronic dry eye disease provides more rapid relief of dry eye signs and symptoms with greater efficacy than tCsA and AT alone.
authors.affiliation: Department of Ophthalmology, Microbiology, and Molecular Biology (J.D.S), Eastern Virginia Medical School, Norfolk, VA; Department of Ophthalmology (E.D.D), New York University School of Medicine, New York, NY; Department of Ophthalmology (E.J.H.), University of Cincinnati, Cincinnati, OH; Departments of Ophthalmology and Plastic Surgery (C.B.S.), University of South Florida College of Medicine, Tampa, FL; Department of Ophthalmology (C.B.S.) University of Florida College of Medicine, Gainesville, FL; Department of Ophthalmology (R.S.), New York University School of Medicine, New York, NY; Medical University of South Carolina (K.D.S.), Charleston, SC; Department of Ophthalmology (M.B.M.), New York University School of Medicine, New York, NY; Department of Ophthalmology (M.B.M.), Tulane University Health Sciences Center, New Orleans, LA; Department of Ophthalmology (H.D.P), Weill Cornell Medical College, New York, NY; Department of Ophthalmology (S.S.L.), University of Minnesota, Minneapolis, MN; Department of Ophthalmology (S.C.P), Cullen Eye Institute, Baylor College of Medicine, Houston, TX; and Department of Pharmacology (S.S.), Eastern Virginia Medical School, Norfolk, VA.
authors.forename: John D
authors.initials: JD
authors.lastname: Sheppard
authors.forename: Eric D
authors.initials: ED
authors.lastname: Donnenfeld
authors.forename: Edward J
authors.initials: EJ
authors.lastname: Holland
authors.forename: Charles B
authors.initials: CB
authors.lastname: Slonim
authors.forename: Renée
authors.initials: R
authors.lastname: Solomon
authors.forename: Kerry D
authors.initials: KD
authors.lastname: Solomon
authors.forename: Marguerite B
authors.initials: MB
authors.lastname: McDonald
authors.forename: Henry D
authors.initials: HD
authors.lastname: Perry
authors.forename: Stephen S
authors.initials: SS
authors.lastname: Lane
authors.forename: Stephen C
authors.initials: SC
authors.lastname: Pflugfelder
authors.forename: Sandeep S
authors.initials: SS
authors.lastname: Samudre
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D000730:Androstadienes / Q000627:therapeutic use*; D018926:Anti-Allergic Agents / Q000627:therapeutic use*; D016572:Cyclosporine / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D015352:Dry Eye Syndromes / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D000069559:Loteprednol Etabonate; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions / Q000627:therapeutic use; D011446:Prospective Studies; D014792:Visual Acuity
chemical_list: D000730:Androstadienes; D018926:Anti-Allergic Agents; D007166:Immunosuppressive Agents; D009883:Ophthalmic Solutions; D016572:Cyclosporine; D000069559:Loteprednol Etabonate