title: Reversibility of dry eye deceleration after topical cyclosporine 0.05% withdrawal.
abstract: OBJECTIVE
  To assess the reversibility of clinical benefits of cyclosporine 0.05% (Restasis(®); Allergan, Inc., Irvine, CA) therapy and the therapeutic gain after its delayed use by switching treatment modalities in patients with dry eyes who completed a 1-year course of therapy with artificial tears (Refresh Endura(®); Allergan, Inc., Irvine, CA) or cyclosporine 0.05%.
  
  
  METHODS
  This was a single-center, prospective, investigator-masked, longitudinal extension trial. Patients who had been treated with cyclosporine 0.05% in the first year of study were randomized in a 2:1 ratio to either cyclosporine 0.05% (Cs-Cs; n=20) or artificial tears (Cs-At; n=8), and those who had been originally randomized to artificial tears were switched to cyclosporine 0.05% (At-Cs; n=20) in the second year of study. Patients received study drugs twice daily for 12 months. Disease severity was assessed according to the International Task Force consensus guideline at months 0 and 12. Signs and symptoms were evaluated at baseline (month 0) and months 4, 8, and 12.
  
  
  RESULTS
  At baseline, most patients with Cs-Cs and Cs-At (>90%) had level 2 disease severity, whereas almost half of the patients with At-Cs had level 3 disease severity. At month 12, a significantly higher percentage of patients with Cs-Cs and At-Cs than patients with Cs-At had the same or lower disease severity (P<0.001); whereas half of patients with Cs-At, compared with patients with no Cs-Cs and At-Cs, had disease progression at month 12. Throughout the study, dry eye signs and symptoms continuously improved in patients with Cs-Cs and At-Cs, whereas they constantly worsened in patients with Cs-At. At month 12, patients with Cs-Cs and At-Cs had significantly greater mean percentage improvement from baseline than did patients with Cs-At in Schirmer test scores, tear breakup time, Oxford staining scores, Ocular Surface Disease Index scores, and conjunctival goblet cell density (P<0.001). Overall, sign and symptom scores of patients with At-Cs did not improve as much as they did for patients with Cs-Cs.
  
  
  CONCLUSIONS
  Cyclosporine 0.05% withdrawal led to disease progression, thus indicating the necessity for maintenance therapy. Earlier treatment with cyclosporine 0.05% may result in improved outcomes.
authors: Lakeside Eye Group, SC, Chicago, Illinois 60601, USA. sanjayrao@pol.net
authors: Sanjay N
authors: SN
authors: Rao
mesh_terms: D002452:Cell Count; D016572:Cyclosporine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018450:Disease Progression; D004334:Drug Administration Schedule; D015352:Dry Eye Syndromes / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D020397:Goblet Cells / Q000473:pathology; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D011446:Prospective Studies; D012720:Severity of Illness Index; D016037:Single-Blind Method; D013375:Substance Withdrawal Syndrome
chemical_list: D007166:Immunosuppressive Agents; D009883:Ophthalmic Solutions; D016572:Cyclosporine