title: Safety and Efficacy of an Artificial Tear Containing 0.3% Hyaluronic Acid in the Management of Moderate-to-Severe Dry Eye Disease.
abstract: OBJECTIVE
  To evaluate the safety and efficacy of a new 0.3% hyaluronic acid artificial tear compared with 0.9% saline solution (0.9% NaCl) in moderate-to-severe dry eye patients after 1 month's use.
  
  
  METHODS
  A total of 16 patients with moderate-to-severe dry eye were included in this crossover study. After a 1-week washout period, patients used the experimental (Visaid 0.3%) or control solution (0.9% NaCl), selected randomly, applying three to eight drops daily for a month. After another washout period, patients used the other solution in the same way. Percentage of change (ΔY) was calculated and analyzed for (1) safety variables: visual acuity, intraocular pressure, and ophthalmoscopy evaluation; (2) efficacy variable: Ocular Surface Disease Index (OSDI) questionnaire; and (3) secondary variables: biomicroscopy findings, fluorescein corneal staining, lissamine green conjunctival staining, tear breakup time (TBUT), contrast sensitivity, Schirmer test, and subject satisfaction.
  
  
  RESULTS
  There were no significant differences in the safety parameters for either solution. After using Visaid 0.3%, patients showed significant improvements in OSDI score (ΔY: -9.66%±10.90), tarsal hyperemia (ΔY: -16.67%±27.89), corneal staining extension (ΔY: -34.90%±42.41), TBUT (ΔY: 13.98%±26.19), and subjective satisfaction (ΔY: 38.06%±47.06). When using 0.9% NaCl, Schirmer test results were significantly worse (ΔY: -11.47%±19.27). A significant difference between the 2 solutions was found in TBUT (ΔY: 13.98%±26.19 vs. 10.15%±42.34, respectively; P=0.0214).
  
  
  CONCLUSIONS
  Visaid 0.3% is a safe product with some benefits over 0.9% NaCl in reducing ocular symptoms and improving some ocular signs in patients with moderate-to-severe dry eye.
authors.affiliation: Instituto de Oftalmobiología Aplicada (A.L.-d.l.R., J.P.-F., F.B.A., M.J.G.-G.), Universidad de Valladolid, Valladolid, Spain; CIBER-BNN (J.P.-F., M.J.G.-G.), Valladolid, Spain; and Research and Development Department (R.U.R.), Avizor S.A., Madrid, Spain.
authors.forename: Alberto
authors.initials: A
authors.lastname: López-de la Rosa
authors.forename: José
authors.initials: J
authors.lastname: Pinto-Fraga
authors.forename: Francisco
authors.initials: F
authors.lastname: Blázquez Arauzo
authors.forename: Rubén
authors.initials: R
authors.lastname: Urbano Rodríguez
authors.forename: María J
authors.initials: MJ
authors.lastname: González-García
mesh_terms: D000328:Adult; D000368:Aged; D015350:Contrast Sensitivity / Q000502:physiology; D003315:Cornea / Q000378:metabolism; D018592:Cross-Over Studies; D004311:Double-Blind Method; D015352:Dry Eye Syndromes / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D007429:Intraocular Pressure / Q000502:physiology; D065346:Lubricant Eye Drops / Q000009:adverse effects / Q000737:chemistry / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D014792:Visual Acuity / Q000502:physiology
chemical_list: D065346:Lubricant Eye Drops; D006820:Hyaluronic Acid