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M. Y. Su, H. D. Perry, E. D. Donnenfeld, J. R. Wittpenn; The Effect of Decreasing Cyclosporine 0.05% on Dry Eye Disease After One Year of Therapy. Invest. Ophthalmol. Vis. Sci. 2007;48(13):374.
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Evaluate the efficacy of once-daily (QD) vs. twice-daily (BID) topical cyclosporine 0.05% (Restasis®; Allergan Inc., Irvine, CA) in patients who have already completed 12 months of BID Restasis therapy.
Prospective, randomized, single-masked, parallel group comparison of 100 patients who have already been treated with Restasis for at least twelve months for dry eye. Patients were randomized either to continue Restasis BID (n = 50) or decrease to Restasis QD (n = 50) over a 6 month period. Principal outcome measures: fluorescein tear break-up time (TBUT), corneal fluorescein staining score (FSS), ocular surface lissamine-green staining score (LISS), Schirmer’s tear test, and Ocular Surface Disease Index (OSDI). All patients were evaluated at baseline, 3 & 6 months.
At 6 months, patients on Restasis QD demonstrated statistically significant improvement in TBUT (4.13 seconds [n = 37] vs. 3.11 seconds at baseline [n=50]; P = 0.0003) and LISS (4.42 [n = 37] vs. 6.51 at baseline [n = 50]; P = 0.024). FSS, Schirmer’s, and OSDI were not significantly different at 6 months compared to baseline (P > 0.05). At the conclusion of the study, OSDI was significantly superior in the QD group compared to the BID group (15.91 [n = 37] vs. 22.62 [n = 48], P < 0.05). The other outcome measures between QD and BID were not significantly different (P > 0.05). 7 out of 50 patients (14%) in the QD group (versus 0% in the BID group) ended the study early due to lack of efficacy (P < 0.05). These 7 failure patients in the QD group went back to BID dosing.
The majority of dry eye patients who are already controlled on Restasis BID for at least a year can maintain suppression of disease and show improvement after decreasing to Restasis QD.
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