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The effect of decreasing the dosage of cyclosporine A 0.05% on dry eye disease after 1 year of twice-daily therapy.

AbstractPURPOSE:
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.
DESIGN:
Prospective, randomized, single-masked, parallel group comparison.
PARTICIPANTS:
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).
MAIN OUTCOME MEASURES:
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.
AuthorsMichael Y Su, Henry D Perry, Allon Barsam, Alicia R Perry, Eric D Donnenfeld, John R Wittpenn, Gerard D'Aversa
JournalCornea (Cornea) Vol. 30 Issue 10 Pg. 1098-104 (Oct 2011) ISSN: 1536-4798 [Electronic] United States
PMID21407074 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial)
Chemical References
  • Emulsions
  • Immunosuppressive Agents
  • Cyclosporine
Topics
  • Administration, Topical
  • Adult
  • Aged
  • Aged, 80 and over
  • Cyclosporine (administration & dosage)
  • Dry Eye Syndromes (drug therapy, metabolism)
  • Emulsions
  • Female
  • Humans
  • Immunosuppressive Agents (administration & dosage)
  • Male
  • Middle Aged
  • Prospective Studies
  • Single-Blind Method
  • Tears (chemistry, metabolism)
  • Treatment Outcome

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