Abstract:
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.
*unstratified / baseline stratified CMH–test
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.
Keywords: clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled • cornea: tears/tear film/dry eye