title: An evaluation of the efficacy of a cyclosporine-based dry eye therapy when used with marketed artificial tears as supportive therapy in dry eye.
abstract: OBJECTIVE
  To evaluate the efficacy of marketed artificial tears in relieving the signs and symptoms of dry eye when used as supportive therapy to a cyclosporine-based ophthalmic emulsion.
  
  
  METHODS
  Sixty-one patients were enrolled in this randomized, investigator-masked, parallel study of 6 months' duration. Eligible patients needed a Schirmer I score without anesthesia of 7 mm or less at day -7 and to answer that they needed artificial tears at least "some of the time." Corneal staining of 3 or more (National Eye Institute grid, 15 points) at day -7 and day 0 in the same eye was also required. Patients were randomized to one of three regimens: Restasis (0.05% cyclosporine) twice per day with Systane used a minimum of once per day (Restasis + Systane); Restasis twice per day with Refresh Tears used a minimum of once per day (Restasis + Refresh); and Systane alone used four times per day. Signs and symptoms were measured at days -7, 0, 7, 14, 28, 42, 120, and 180.
  
  
  RESULTS
  A statistical difference was seen in favor of Restasis + Systane versus Restasis + Refresh for corneal staining (P = 0.0048) change from baseline and a trend (P = 0.0725) for increased tear film breakup time at 6 months. There were no differences between treatment groups for Schirmer score, conjunctival staining, or conjunctival injection. Significant differences were seen in favor of Restasis + Systane versus Restasis + Refresh for less ocular burning (P = 0.0210), stinging (P = 0.0314), grittiness (P = 0.0128), and dryness (P = 0.0132). Systane was better than Restasis + Refresh for less burning (P = 0.0288), dryness (P = 0.0480), and scratchiness (P = 0.0294).
  
  
  CONCLUSIONS
  Results indicate that the choice of concomitant therapy used with Restasis has significant effects on outcome measures. Both supportive therapies were compatible with Restasis.
authors.affiliation: Sall Eye Care, Bellflower, CA, USA.
authors.forename: Ken N
authors.initials: KN
authors.lastname: Sall
authors.forename: Stephen M
authors.initials: SM
authors.lastname: Cohen
authors.forename: Mike T
authors.initials: MT
authors.lastname: Christensen
authors.forename: Jerry M
authors.initials: JM
authors.lastname: Stein
mesh_terms: D000328:Adult; D016572:Cyclosporine / Q000008:administration & dosage / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D015352:Dry Eye Syndromes / Q000188:drug therapy*; D004655:Emulsions; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions / Q000008:administration & dosage / Q000627:therapeutic use*; D017060:Patient Satisfaction; D016037:Single-Blind Method; D016896:Treatment Outcome
chemical_list: D004655:Emulsions; D007166:Immunosuppressive Agents; D009883:Ophthalmic Solutions; D016572:Cyclosporine