title: Prospective Randomized Trial Comparing Efficacy of Topical Loteprednol Etabonate 0.5% Versus Cyclosporine-A 0.05% for Treatment of Dry Eye Syndrome Following Hematopoietic Stem Cell Transplantation.
abstract: OBJECTIVE
  To evaluate the safety and efficacy of topical loteprednol etabonate (LE) 0.5% compared with cyclosporine A (CsA) 0.05% for the prophylaxis and treatment of dry eye syndrome (DES) after hematopoietic stem cell transplantation (HSCT).
  
  
  METHODS
  Seventy-five patients were randomized to LE (n = 76 eyes of 38 patients) or CsA (n = 74 eyes of 37 patients) pre-HSCT. Lissamine green and fluorescein staining, tear break-up time, tear osmolarity (Osm), Schirmer score (Sch), intraocular pressure, visual acuity, and Ocular Surface Disease Index were assessed pre-HSCT, 3, 6, 9, and 12 months post-HSCT.
  
  
  RESULTS
  There were no differences in DES incidence (P = 0.22; log-rank test) or progression (P = 0.41; log-rank test) between the 2 treatment arms during the course of the study. Among eyes with no DES at enrollment, the Kaplan-Meier analysis yielded a 90% rate of DES development in cyclosporine-treated eyes and a 79% rate of DES development in LE-treated eyes by 12 months post-HSCT. The Kaplan-Meier analysis of eyes with DES at enrollment demonstrated a 38% rate of disease progression among cyclosporine-treated eyes and a 26% rate of disease progression among loteprednol-treated eyes by 12 months. No patient in either group had an elevation of 10 mm Hg or greater from baseline at any study visit, and no patients had their treatment discontinued for elevation in intraocular pressure.
  
  
  CONCLUSIONS
  Pre-HSCT initiation of LE 0.5% appears to be safe and may be as effective as CsA 0.5% for the treatment and prophylaxis of DES following HSCT.
authors: *Department of Ophthalmology and Visual Sciences, University of Michigan, Ann Arbor, MI; and †Department of Ophthalmology, Massachusetts Eye and Ear Infirmary, Harvard Medical School, Boston, MA.
authors: Grace E
authors: GE
authors: Boynton
authors: Duna
authors: D
authors: Raoof
authors: Leslie M
authors: LM
authors: Niziol
authors: Munira
authors: M
authors: Hussain
authors: Shahzad I
authors: SI
authors: Mian
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000368:Aged; D018926:Anti-Allergic Agents / Q000008:administration & dosage*; D016572:Cyclosporine / Q000008:administration & dosage*; D015352:Dry Eye Syndromes / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects*; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D007429:Intraocular Pressure; D000069559:Loteprednol Etabonate / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions; D009994:Osmolar Concentration; D011446:Prospective Studies; D013666:Tears / Q000737:chemistry; D016896:Treatment Outcome; D014792:Visual Acuity; D055815:Young Adult
chemical_list: D018926:Anti-Allergic Agents; D007166:Immunosuppressive Agents; D009883:Ophthalmic Solutions; D016572:Cyclosporine; D000069559:Loteprednol Etabonate