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G.W. Ousler, R. Haque, A. Weichselberger, N.C. Yannoulis, M.B. Abelson; Comparison of Pimecrolimus 1%, 0.3% and 0.1% With Vehicle for the Treatment of Dry Eye in the Controlled Adverse Environment (CAE) Model . Invest. Ophthalmol. Vis. Sci. 2005;46(13):2031.
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To compare safety & efficacy of pimecrolimus 1%,0.3% and 0.1% ophthalmic suspensions with vehicle for treatingdry eye in the CAE model. Randomized, double–masked,parallel group, 16–week, single–center study. Dryeye patients entered a 4–week run–in period withvehicle treatment and underwent screening in the CAE, an environmentallyregulated room that standardizes humidity, temperature, airflow,and visual tasking. Subjects with worsened dry eye symptoms& corneal staining post CAE were randomized to dose BIDwith pimecrolimus or vehicle for 12 weeks. Follow–up CAEexposure and pre & post exposure exams occurred at weeks2, 4, 8, 12. 105 (1%: 26, 0.3%: 28, 0.1%: 24, vehicle:27) patients completed per protocol. Mean differences betweenpimecrolimus & vehicle for inferior corneal staining (0–4scale) after 12 weeks of treatment (primary efficacy variable– inferior corneal staining post CAE) are shown. Negativevalues favor pimecrolimus.
Pimecrolimus 1% results suggested a treatment effect on cornealstaining pre & post CAE. The maximum effect of pimecrolimus1% occurred after 4 weeks and was sustained for the study. Similartrends were observed for sum corneal and conjunctival stainingpre & post CAE. All treatments were well tolerated. The data suggest a treatment effect for pimecrolimus in thereduction of corneal staining under both environmental and adverseconditions. Further evaluation of safety & efficacy of pimecrolimusfor dry eye therapy is warranted.
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