title: The effect of decreasing the dosage of cyclosporine A 0.05% on dry eye disease after 1 year of twice-daily therapy.
abstract: OBJECTIVE
  To evaluate the effect of decreasing topical cyclosporine 0.05% (tCSA) (Restasis; Allergan, Irvine, CA) from twice-daily dosing to once-daily dosing in patients who have already completed 12 months of twice-daily therapy for dry eye disease.
  
  
  METHODS
  Prospective, randomized, single-masked, parallel group comparison.
  
  
  METHODS
  One hundred patients who had already been treated with tCSA twice daily for more than 1 year were randomized either to continue tCSA twice daily (n = 50) or to decrease tCSA once daily (n = 50).
  
  
  METHODS
  Clinical measurement of dry eye variables was performed for all patients at baseline, 3 months, and 6 months. Mean data were used for within-group (longitudinal analysis) and between-group comparisons (once daily vs. twice daily).
  
  
  METHODS
  Fluorescein tear break-up time, corneal fluorescein staining score, lissamine green staining score, Schirmer tear test, and ocular surface disease index.
  
  
  RESULTS
  At the end of the study, patients whose treatment dose was decreased to once daily demonstrated statistically significant improvement in tear break-up time [4.13 seconds (n = 37) vs. 3.11 seconds at baseline (n = 50); P = 0.0003] and lissamine green staining score [4.42 (n = 37) vs. 6.51 at baseline (n = 50); P = 0.024]; fluorescein staining score, Schirmer test results, and ocular surface disease index did not change significantly (P > 0.05). Furthermore, the once-daily group demonstrated significantly superior ocular surface disease index compared with the twice daily group [15.91 (n = 37) vs. 22.62 (n = 48); P = 0.0496]. The remaining outcome measures between once daily and twice daily were not significantly different (P > 0.05). Seven of 50 patients (14%) in the once-daily group (vs. 0% in the twice-daily group) ended the study early because of worsening dry eye symptoms (P < 0.05) and went back to twice-daily dosing.
  
  
  CONCLUSIONS
  For patients with dry eye that has been controlled with tCSA twice daily for at least 1 year, decreasing to tCSA once daily may still allow suppression of the dry eye disease.
authors.affiliation: Nassau University, Rockville Centre, NY, USA.
authors.forename: Michael Y
authors.initials: MY
authors.lastname: Su
authors.forename: Henry D
authors.initials: HD
authors.lastname: Perry
authors.forename: Allon
authors.initials: A
authors.lastname: Barsam
authors.forename: Alicia R
authors.initials: AR
authors.lastname: Perry
authors.forename: Eric D
authors.initials: ED
authors.lastname: Donnenfeld
authors.forename: John R
authors.initials: JR
authors.lastname: Wittpenn
authors.forename: Gerard
authors.initials: G
authors.lastname: D'Aversa
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016572:Cyclosporine / Q000008:administration & dosage*; D015352:Dry Eye Syndromes / Q000188:drug therapy* / Q000378:metabolism; D004655:Emulsions; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016037:Single-Blind Method; D013666:Tears / Q000737:chemistry / Q000378:metabolism; D016896:Treatment Outcome
chemical_list: D004655:Emulsions; D007166:Immunosuppressive Agents; D016572:Cyclosporine