title: Treatment of Sjögren's syndrome dry eye using 0.03% tacrolimus eye drop: Prospective double-blind randomized study.
abstract: OBJECTIVE
  To describe the clinical efficacy of the treatment of Sjögren's syndrome dry eye using 0.03% tacrolimus eye drop.
  
  
  METHODS
  Prospective double-blind randomized study.
  
  
  METHODS
  Institutional outpatient clinic.
  
  
  METHODS
  Forty-eight eyes of twenty-four patients with dry eye related to Sjögren syndrome were enrolled in this study. The patients were randomized in 2 groups: tacrolimus (n=14) and vehicle (n=10) group.
  
  
  METHODS
  The tacrolimus group received a vial containing tacrolimus 0.03% (almond oil as vehicle) and the other group received the almond oil vehicle. All patients were instructed to use the eye drops every 12h in the lower conjunctival sac.
  
  
  METHODS
  Schirmer I test, break-up-time (BUT), corneal fluorescein and Rose Bengal staining scores were evaluated in all patients one day before the treatment (baseline), 7, 14, 28 and 90 days after treatment with the eye drops.
  
  
  RESULTS
  The average fluorescein and Rose Bengal scores improved statistically after 7 days of treatment and even more after 90 days. The average Schirmer I and BUT values were unchanged after 7, 14 and 21 days but did show an improvement relative to baseline after 28 days of treatment. Schirmer I, BUT, fluorescein and Rose Bengal did not show any statistical significance in the vehicle group.
  
  
  CONCLUSIONS
  Topical 0.03% tacrolimus eye drop improved tear stability and ocular surface status in cases of inflammatory or SS-related dry eye.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT01850979.
authors.affiliation: Department of Ophthalmology, University of São Paulo, School of Medicine (Hospital das Clínicas of da Universidade de São Paulo-São Paulo - HC-USP), Brazil; Department of Ophthalmology, Santa Casa de São Paulo, Brazil. Electronic address: bernardokaplan@yahoo.com.br.
authors.forename: Bernardo Kaplan
authors.initials: BK
authors.lastname: Moscovici
authors.affiliation: Department of Ophthalmology, University of São Paulo, School of Medicine (Hospital das Clínicas of da Universidade de São Paulo-São Paulo - HC-USP), Brazil; Department of Ophthalmology, Santa Casa de São Paulo, Brazil.
authors.forename: Ricardo
authors.initials: R
authors.lastname: Holzchuh
authors.affiliation: Department of Ophthalmology, University of São Paulo, School of Medicine (Hospital das Clínicas of da Universidade de São Paulo-São Paulo - HC-USP), Brazil; Department of Ophthalmology, Santa Casa de São Paulo, Brazil.
authors.forename: Fernando Eiji
authors.initials: FE
authors.lastname: Sakassegawa-Naves
authors.affiliation: Department of Ophthalmology, University of São Paulo, School of Medicine (Hospital das Clínicas of da Universidade de São Paulo-São Paulo - HC-USP), Brazil; Department of Ophthalmology, Santa Casa de São Paulo, Brazil.
authors.forename: Diego Ricardo
authors.initials: DR
authors.lastname: Hoshino-Ruiz
authors.affiliation: Department of Ophthalmology, University of São Paulo, School of Medicine (Hospital das Clínicas of da Universidade de São Paulo-São Paulo - HC-USP), Brazil; Department of Ophthalmology, Santa Casa de São Paulo, Brazil.
authors.forename: Marcos Bottene Villa
authors.initials: MB
authors.lastname: Albers
authors.affiliation: Department of Ophthalmology, University of São Paulo, School of Medicine (Hospital das Clínicas of da Universidade de São Paulo-São Paulo - HC-USP), Brazil.
authors.forename: Ruth Miyuki
authors.initials: RM
authors.lastname: Santo
authors.affiliation: Department of Ophthalmology, University of São Paulo, School of Medicine (Hospital das Clínicas of da Universidade de São Paulo-São Paulo - HC-USP), Brazil; Department of Ophthalmology, Santa Casa de São Paulo, Brazil.
authors.forename: Richard Yudi
authors.initials: RY
authors.lastname: Hida
mesh_terms: D060433:Administration, Ophthalmic; D004311:Double-Blind Method; D015352:Dry Eye Syndromes / Q000175:diagnosis* / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions / Q000008:administration & dosage; D011446:Prospective Studies; D012859:Sjogren's Syndrome / Q000175:diagnosis* / Q000188:drug therapy*; D016559:Tacrolimus / Q000008:administration & dosage*; D013666:Tears / Q000187:drug effects; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D009883:Ophthalmic Solutions; D016559:Tacrolimus
keywords: Keratoconjunctivitis sicca; Sjogren's syndrome; Tacrolimus