Efficacy Study of FK-506 and Cyclosporine in Vernal Keratoconjunctivits (VKC)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Double-blind Comparison of 0.1% Tacrolimus Ophthalmic Ointment and 2% Cyclosporine Eye Drops in the Treatment of Vernal Keratoconjunctivits (VKC)

Conditions
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Keratoconjunctivitis, Vernal

Intervention / Treatment
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* Drug: tacrolimus
* Drug: cyclosporins


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: tacrolimus<br>Tacrolimus arm: active 0.1% tacrolimus eye ointment BID + placebo eye drops QID | Drug: tacrolimus<br>* 0.1% ointment,apply bid, 8 weeks<br>|
| Active Comparator: cyclosporine<br>2% cyclosporine eye drops apply QID + placebo eye ointment apply bid | Drug: cyclosporins<br>* 2% eyclosporine eye drops apply 1 drop to each eye QID<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall subjective ocular symptom scores |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall objective ocular signs |  | 8 weeks | 
| overall side-effect scores |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vernal keratoconjunctivitis, FK-506, tacrolimus, cyclosporine, children