Abstract
Aims
The main objective of this explorative study was to evaluate if tacrolimus ointment could be safer than corticosteroid ointment, with special reference to the intraocular pressure in the treatment of eyelid eczema in patients with atopic keratoconjunctivitis (AKC). Secondary aims were to compare the effects of the treatments on eyelid eczema and their potential impact on ocular surface inflammation.
Methods
Tacrolimus 0.1% ointment and clobetasone butyrate 0.05% ointment were compared in a double-masked explorative crossover study. In total, 25 AKC patients were included. Each ointment was applied twice daily for 3 weeks, with 2 weeks of washout before, between, and after treatments. Efficacy was determined by eye examination and the patients' own symptom scoring. Cytology and cytokine measurements were performed on tear samples. Safety parameters were intraocular pressure, presence of bacteria and fungi, and the patients' reports of adverse events. The validity of the crossover design was explored with analysis of variance, and the effect of each medication was calculated with paired t-test and Wilcoxon paired test.
Results
A total of 20 patients completed the study. Both treatments were effective in reducing signs and symptoms of eyelid eczema, with a near superior benefit for tacrolimus in terms of eczema (total skin score) signs (P=0.05). No serious adverse events occurred and interestingly, intraocular pressure was not evidently affected by either treatment.
Conclusion
Tacrolimus 0.1% ointment is a promising alternative therapy for eyelid eczema in AKC patients. Long-term studies are needed to further determine the value of tacrolimus in this patient group.
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Acknowledgements
We thank Professor K Nordlind, dermatologist at Karolinska University Hospital for accepting the task to be the monitor of the study, research nurse Mikaela Taube for assistance and help with the double-masked design, Berit Spångberg and Margareta Oscarsson for valuable technical support, Rodica Lenkei for help and advise concerning cytokine analysis, and Bo Nilsson for important statistical help. Grants from Crown Princess Margareta's Foundation for the Visually Impaired (KMA), Stiftelsen Synfrämjandets Forskningsfond, the Swedish Research Council, the Swedish Asthma and Allergy Association, the Swedish Cancer and Allergy Fund, the Hesselman Foundation, the Mieczislaw Hubaczs Foundation for Eye Research and from the Karolinska Institute supported this work. No sponsor was involved in the study.
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Nivenius, E., van der Ploeg, I., Jung, K. et al. Tacrolimus ointment vs steroid ointment for eyelid dermatitis in patients with atopic keratoconjunctivitis. Eye 21, 968–975 (2007). https://doi.org/10.1038/sj.eye.6702367
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DOI: https://doi.org/10.1038/sj.eye.6702367
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