title: Safety and Efficacy of Cortisol Phosphate in Hyaluronic Acid Vehicle in the Treatment of Dry Eye in Sjogren Syndrome.
abstract: Evaluation of 0.3% cortisol phosphate eye drops in hyaluronic acid vehicle in the treatment of dry eye in Sjogren Syndrome.
  
  
  
  This prospective, single-center, masked (single blind), randomized controlled study included 40 female patients divided into 2 groups, group 1 treated with Idracemi, 0.3% cortisol phosphate eye drops twice a day, and group 2 treated with Cortivis, 0.3% cortisol phosphate in hyaluronic acid vehicle, with the same posology. Screening (day -7), randomization (day 0), follow-up (day 7), and termination (day 28) visits were conducted. Symptoms (VAS) questionnaire, tear film breakup time, corneo-conjunctival stain, intraocular pressure (IOP) measurement, and fundus examination were performed at each visit. Conjunctival impression cytology for human leukocyte antigen-DR (HLA-DR) expression at visit 1 and 4 was also performed.
  
  
  
  No changes in IOP or fundus examination were observed in either group at each time point. Group 1 showed at day 28 a statistically significant amelioration of symptoms and reduction of HLA-DR expression. Group 2 showed at day 7 statistically significant improvement of corneal and conjunctival stain versus baseline and versus group 1; the symptom score was statistically significantly better than baseline and versus group 1 after 28 days too. The HLA-DR expression and the epithelial cell area were statistically significantly reduced versus baseline and versus group 1 at the same time.
  
  
  
  Cortisol phosphate proved to be safe and effective in treating dry eye in Sjogren Syndrome patients in both formulations. However, the formula with hyaluronic acid vehicle proved to be more effective. Both formulations were very well tolerated.
authors.affiliation: 1 ISPRE Oftalmica , Genova, Italy .|2 Dipartimento di Scienze Neurologiche, Oftalmologia, Genetica e Scienze Materno Infantili, Università di Genova , Genova, Italy .
authors.forename: Maurizio
authors.initials: M
authors.lastname: Rolando
authors.affiliation: 2 Dipartimento di Scienze Neurologiche, Oftalmologia, Genetica e Scienze Materno Infantili, Università di Genova , Genova, Italy .
authors.forename: Aldo
authors.initials: A
authors.lastname: Vagge
mesh_terms: D004311:Double-Blind Method; D015352:Dry Eye Syndromes / Q000150:complications* / Q000188:drug therapy*; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage*; D006854:Hydrocortisone / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions / Q000008:administration & dosage / Q000627:therapeutic use*; D010710:Phosphates / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D011446:Prospective Studies; D012859:Sjogren's Syndrome / Q000150:complications*
chemical_list: D009883:Ophthalmic Solutions; D010710:Phosphates; D006820:Hyaluronic Acid; D006854:Hydrocortisone
keywords: Sjogren syndrome; corticosteroids; cortisol; dry eye; hyaluronic acid; inflammation