Topical Tacrolimus in Vernal Keratoconjunctivitis

Study Overview
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Brief Summary
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The main aim of this study is to evaluate the efficacy and safety of topical tacrolimus 0.01% eyedrops in patients with vernal keratoconjunctivitis.

Detailed Description
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A total of 20 patients with bilateral symmetrical vernal keratoconjunctivitis will be included. Each patient will undergo a complete ophthalmologic evaluation. Patient will be placed at random on topical Tacrolimus 0.01% ophthalmic solution in one eye and placebo eyedrops in the fellow eye. Patients will undergo ophthalmologic examination at one week and after one month. Photos will be taken. The outcome measures include graded symptoms, graded signs, and laboratory investigations. Symptoms of itching, redness, foreign body sensation, tearing and discharge following will be recorded before and after treatment. The grading of clinical signs of conjunctival hyperemia, conjunctival papillary hypertrophy, perilimbal infiltrates, Trantas dots, superficial punctate keratopathy will be recorded before and after treatment. Conjunctival surface temperature will be determined before and after treatment. Conjunctival scrapings will be stained with Giemsa and will be assessed before and after therapy and number of eosinophils per hpf will be determined and recorded.

Official Title
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Topical Tacrolimus in Vernal Keratoconjunctivitis

Conditions
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Vernal Keratoconjunctivitis

Intervention / Treatment
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* Drug: Topical tacrolimus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: with bilateral symmetrical palpebral and limbal vernal keratoconjunctivitis Patients 6-18 years of age Exclusion Criteria: Pregnant patients Patients on systemic therapy for other allergic disorders Patients who cannot come for follow-up Patients who are on other topical medications for other comorbid ocular conditions

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Topical tacrolimus<br>20 eyes with active Vernal Keratoconjunctivitis | Drug: Topical tacrolimus<br>* Topical tacrolimus 0.01% twice daily for one month<br>* Other names: Tacrolimus eye drops;|
| Placebo Comparator: Placebo<br>20 eyes with active Vernal Keratoconjunctivitis | Drug: Topical tacrolimus<br>* Topical tacrolimus 0.01% twice daily for one month<br>* Other names: Tacrolimus eye drops;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy of Topical Tacrolimus in Vernal Keratoconjunctivitis | To evaluate the efficacy of topical tacrolimus 0.01 eye drops in patients with vernal keratoconjunctivitis in symptoms of redness, itching, foreign body sensation and discharge and signs of conjunctival hyperemia,perlimbal infiltrates, Trantas dots and papillary reaction | Five months |