Clinical Study
Eye (2007) 21, 968–975; doi:10.1038/sj.eye.6702367; published online 5 May 2006
Tacrolimus ointment vs steroid ointment for eyelid dermatitis in patients with atopic keratoconjunctivitis
E Nivenius1, I van der Ploeg1, K Jung2, E Chryssanthou2, M van Hage3 and P G Montan1
- 1Department of Clinical Neuroscience, Karolinska Institutet, Division of Ophthalmology, St Erik's Eye Hospital, Stockholm, Sweden
- 2Microbiology and Tumor Biology Center, Division of Clinical Microbiology, Stockholm, Sweden
- 3Department of Medicine, Clinical Immunology and Allergy Unit, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden
Correspondence: Dr E Nivenius, Department of Clinical Neuroscience, Karolinska Institutet, Division of Ophthalmology, St Erik's Eye Hospital, Polhemsgatan 50, Stockholm SE-112 82, Sweden. Tel: +46 867 23000; Fax: +46 867 23352; E-mail: emma.nivenius@sankterik.se
Received 17 November 2005; Revised 16 March 2006; Accepted 16 March 2006; Published online 5 May 2006.
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.
Keywords:
atopic keratoconjunctivitis, steroids, cytokine, eyelid eczema, intraocular pressure, tacrolimus
