Introduction:The purpose of this study was to compare the efficacy of tacrolimus,fluorometholone,and saline in the treatment of mild to moderate contact lens-induced papillary conjunctivitis (CLPC).Methods:This was a double-masked,randomized pilot study.A total of 18 soft contact lens users(n =36 eyes) with mild to moderate papillary conjunctivitis were enrolled.Subjects were randomly assigned into three groups to receive tacrolimus 0.05%,fluorometholone 0.1%,or saline (sodium chloride 0.9%).Drugs were prescribed at the baseline visit (visit 1) and instilled twice daily for 4 weeks.Follow-up visits were taken at week 1 (visit 2),week 2 (visit 3),week 4 (visit 4,drug usage suspended at this visit),and week 6 (visit 5,2 weeks after interrupting eye drops).Contact lens use was discontinued during the 6 weeks of the study,and variables assessed were symptoms and signs,tear film status,and intraocular pressures.Conjunctival impression cytology was performed at baseline and visit 5 to assess ocular surface status.Results:Mean roughness and redness scores decreased significantly from visit 1 to visit 5,but the variation tendency was comparable in all groups (P =0.180 and 0.889,respectively).Subjective symptom parameters were improved in all CLPC patients at visit 5,and there was no remarkable difference in symptom reduction in three groups.The mean Schirmer value and mean break-up time (BUT) did not change significantly in the three groups during the study.Ocular surface findings by impression cytology improved significantly after three treatments.Intraocular pressure fluctuation from baseline to 6-week follow-up was not statistically significant in all subjects.No adverse treatment-related event was observed in any study group.Conclusions:Tacrolimus 0.05% may be a safe and effective treatment for mild to moderate CLPC and is comparable with fluorometholone 0.1% in efficacy.Contact lens cessation accompanied with saline may also be effective in treating mild to moderate CLPC.