title: Topical Fluorometholone Protects the Ocular Surface of Dry Eye Patients from Desiccating Stress: A Randomized Controlled Clinical Trial.
abstract: OBJECTIVE
  To assess the efficacy of topical 0.1% fluorometholone in dry eye disease (DED) patients for ameliorating the worsening of the ocular surface when exposed to adverse environments.
  
  
  METHODS
  Single-center, double-masked, randomized, vehicle-controlled clinical trial.
  
  
  METHODS
  Forty-one patients showing moderate to severe DED.
  
  
  METHODS
  Patients randomly received 1 drop 4 times daily of either topical 0.1% fluorometholone (FML group) or topical polyvinyl alcohol (PA group) for 22 days. Corneal and conjunctival staining, conjunctival hyperemia, tear film breakup time (TBUT), tear osmolarity, and the Symptom Assessment in Dry Eye (SANDE) questionnaire scores were determined at baseline. Variables were reassessed on day 21 before and after undergoing a 2-hour controlled adverse environment exposure and again on day 22.
  
  
  METHODS
  Percentage of patients showing an increase 1 point or more in corneal staining and a reduction of 2 points or more (0-10 scale) in SANDE score, after the controlled adverse environment exposure and 24 hours later.
  
  
  RESULTS
  After 21 days of treatment, the FML group showed greater improvements in corneal and conjunctival staining, hyperemia, and TBUT than the PA group (P≤0.03). After the adverse exposure, the percentage of patients having a 1-grade or more increase in corneal staining was significantly (P = 0.03) higher in the PA group (63.1% vs. 23.8%, respectively). Additionally, the FML group showed no significant changes in corneal staining (mean, 0.86; 95% confidence interval [CI], 0.47-1.25; vs. mean, 1.05; 95% CI, 0.59-1.51, for visit 2 and 3, respectively), conjunctival staining (mean, 0.95; 95% CI, 0.54-1.37 vs. mean, 1.19; 95% CI, 0.75-1.63), and hyperemia (mean, 0.71; 95% CI, 0.41-1.02 vs. 1.14; 95% CI, 0.71-1.58) after the exposure, whereas for the PA group, there was significant worsening (P≤0.009) in these variables (corneal staining: mean, 1.95; 95% CI, 1.57-2.33 vs. mean, 2.58; 95% CI, 2.17-2.98; conjunctival staining: mean, 1.68; 95% CI, 1.29-2.08 vs. mean, 2.47; 95% CI, 2.07-2.88; hyperemia: mean, 1.95; 95% CI, 1.63-2.26 vs. mean, 2.84; 95% CI, 2.62-3.07).
  
  
  CONCLUSIONS
  Three-week topical 0.1% fluorometholone therapy is effective not only in reducing ocular surface signs in DED patients, but also especially in preventing exacerbation caused by exposure to a desiccating stress.
authors.affiliation: Instituto Universitario de Oftalmobiología Aplicada, University of Valladolid, Valladolid, Spain; Biomedical Research Networking Center on Bioengineering, Biomaterials and Nanomedicine, Zaragoza, Spain.
authors.forename: José
authors.initials: J
authors.lastname: Pinto-Fraga
authors.affiliation: Instituto Universitario de Oftalmobiología Aplicada, University of Valladolid, Valladolid, Spain; VISIÓN I+D, SL, Valladolid, Spain.
authors.forename: Alberto
authors.initials: A
authors.lastname: López-Miguel
authors.affiliation: Instituto Universitario de Oftalmobiología Aplicada, University of Valladolid, Valladolid, Spain; Biomedical Research Networking Center on Bioengineering, Biomaterials and Nanomedicine, Zaragoza, Spain.
authors.forename: María J
authors.initials: MJ
authors.lastname: González-García
authors.affiliation: Instituto Universitario de Oftalmobiología Aplicada, University of Valladolid, Valladolid, Spain; Biomedical Research Networking Center on Bioengineering, Biomaterials and Nanomedicine, Zaragoza, Spain.
authors.forename: Itziar
authors.initials: I
authors.lastname: Fernández
authors.affiliation: Instituto Universitario de Oftalmobiología Aplicada, University of Valladolid, Valladolid, Spain.
authors.forename: Alberto
authors.initials: A
authors.lastname: López-de-la-Rosa
authors.affiliation: Instituto Universitario de Oftalmobiología Aplicada, University of Valladolid, Valladolid, Spain; Biomedical Research Networking Center on Bioengineering, Biomaterials and Nanomedicine, Zaragoza, Spain.
authors.forename: Amalia
authors.initials: A
authors.lastname: Enríquez-de-Salamanca
authors.affiliation: Allergan, Inc., Irvine, California.
authors.forename: Michael E
authors.initials: ME
authors.lastname: Stern
authors.affiliation: Instituto Universitario de Oftalmobiología Aplicada, University of Valladolid, Valladolid, Spain; Biomedical Research Networking Center on Bioengineering, Biomaterials and Nanomedicine, Zaragoza, Spain. Electronic address: calonge@ioba.med.uva.es.
authors.forename: Margarita
authors.initials: M
authors.lastname: Calonge
mesh_terms: D000287:Administration, Topical; D003228:Conjunctiva / Q000187:drug effects* / Q000473:pathology; D003315:Cornea / Q000187:drug effects* / Q000473:pathology; D003681:Dehydration / Q000150:complications* / Q000473:pathology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D015352:Dry Eye Syndromes / Q000188:drug therapy* / Q000209:etiology / Q000473:pathology; D005260:Female; D005469:Fluorometholone / Q000008:administration & dosage*; D005938:Glucocorticoids / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D005938:Glucocorticoids; D005469:Fluorometholone