Phase III Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Patients With Vernal Keratoconjunctivitis

Study Overview
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Brief Summary
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To investigate the efficacy and safety of FK506 ophthalmic suspension on eye symptoms in patients with vernal keratoconjunctivitis

Detailed Description
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0.1% FK506 ophthalmic suspension were administered twice-a-day to patients with vernal keratoconjunctivitis in whom treatment with topical anti-allergic agents had been ineffective. The primary efficacy endpoint was the mean change from the baseline (before the treatment)in total score for objective clinical signs at the final observation. The safety of FK506 ophthalmic suspension was also investigated.

Official Title
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A Randomized, Placebo-controlled, Double-masked Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Vernal Keratoconjunctivitis

Conditions
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Keratoconjunctivitis, Conjunctivitis

Intervention / Treatment
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* Drug: FK506
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Vernal keratoconjunctivitis patients diagnosed by Guideline of diagnosis and treatment of allergic conjunctival disease Patients with type I reactions defined by skin testing, antibody measurement, etc. Age over 6 years old Exclusion Criteria: Subjects receiving systemic administration or subconjunctival injection of corticosteroid or immunosuppressants(ophthalmic and systemic medications) within 2-weeks of initiation of the study Subjects needed to wear contact lenses during treatment period on a testing eye Subjects complicating an eye infection

Ages Eligible for Study
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Minimum Age: 6 Years

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>FK506 ophthalmic suspension | Drug: FK506<br>* Opthalmic suspension<br>* Other names: tacrolimius;|
| Placebo Comparator: 2<br>Base of eye drops | Drug: placebo<br>* placebo eye drops<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from the baseline (before the treatment) in total score for objective clinical signs at the final observation |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from the baseline in score for objective clinical signs and the score for each objective clinical sign |  | Week 1, 2 and 4 | 
| Subjective symptom score (Visual Analog Scale) |  | 4 weeks | 
| The improvement rate of subjective symptoms |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FK506, Keratoconjunctivitis, vernal keratoconjunctivitis, Tacrolimus