Therapeutic effect of 0.03% tacrolimus ointment for ocular graft versus host disease and vernal keratoconjunctivitis.

PURPOSE: To determine whether topical tacrolimus might prove effective in the treatment of refractory anterior segment inflammatory diseases, and to evaluate its efficacy in eyes with ocular graft versus host disease (GVHD), and vernal keratoconjunctivitis (VKC).
METHODS: Twenty-eight eyes of 14 patients with anterior segment inflammation refractory to steroid treatment were treated with 0.03% tacrolimus ointment at the Samsung Medical Center, Seoul, Korea from March 2008 through August 2009. Seven patients had ocular GVHD and seven had VKC. We evaluated the conjunctival and corneal inflammatory change at one, two, four, and eight weeks after treatment with a scoring system. Time to initial response of treatment and therapeutic effect between GVHD and VKC was also analyzed. After the eight-week treatment period, patients were divided into two groups (maintenance group and discontinuance group). Eight patients maintained the treatment for an additional four months, and six patients discontinued the treatments. Therapeutic effect was also compared between the groups at eight weeks and six months after treatment.
RESULTS: The mean conjunctival and corneal inflammation score was reduced significantly at eight weeks after treatment (p < 0.0001). The therapeutic effect in conjunctival inflammation was first noted at week two after the initial treatment (p = 0.002); reduction in corneal inflammation was first noted at one week (p = 0.0009). When compared according to diagnosis, no therapeutic difference was detected between the groups (p > 0.05). Six months after treatment, we noted no therapeutic differences between the maintenance group and discontinuance group (p > 0.05).
CONCLUSIONS: 0.03% tacrolimus ointment was safe and effective for use in anterior segment inflammatory disease refractory to steroid.

RCT Entities:   Population Interventions Outcomes