Efficacy Study of FK-506 and Cyclosporine in Vernal Keratoconjunctivits (VKC)
Efficacy Study of FK-506 and Cyclosporine in Vernal Keratoconjunctivits (VKC)
The study was a double-blind, parallel study to compare efficacy of 0.1% tacrolimus
 ophthalmic ointment vs 2% cyclosporine eye drops in children with vernal
 keratoconjunctivitis. The duration of the blinded period was 8 weeks followed with 4 weeks of
 open-period of tacrolimus ointment. The hypothesis was that tacrolimus was as effective as
 cyclosporine for the treatment of this condition.
Background: Vernal keratoconjunctivitis (VKC) is a serious, sight-threatening ocular disease,
 occurring mainly in children. Prolonged use of ophthalmic corticosteroids is usually required
 in severe cases which could lead to serious complications such as glaucoma and cataract.
 Cyclosporine and tacrolimus are among newer treatments for VKC.

 Objective: To compare the efficacy of 0.1% tacrolimus (FK-506) ophthalmic ointment with 2%
 cyclosporine eye drops in the treatment of VKC.

 Methods: Twenty-four patients with VKC were recruited. After a 2 week-washout period, they
 were randomized into 2 groups in a double-blinded, parallel fashion. The first group received
 0.1% FK-506 eye ointment with placebo eye drops and the second group received 2% cyclosporine
 eye drops with placebo ointment for 8 weeks. Thereafter, all patients received an
 open-treatment with 0.1% FK-506 eye ointment for another 4 weeks. Subjective ocular symptoms
 and side effects were scored by patients at the entry, and at the end of the 1st, 4th, 8th
 and 12th weeks. Objective ocular signs were evaluated by an ophthalmologist (PK) at all
 follow up visits.
Inclusion Criteria:

 -  patients with clinical diagnosis of vernal keratoconjunctivitis

 Exclusion Criteria:

 -  coexisting ocular diseases such as glaucoma, other corneal disease, ocular infections,
 other coexisting systemic diseases