A Novel Combined Therapy for Refractory Vernal Keratoconjunctivitis

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of 0.1% tacrolimus combined with loteprednol etabonate 0.5%/tobramycin 0.3% (LE/T) in vernal keratoconjunctivitis (VKC) patients resistant to conventional treatment. This prospective 6-mouth period study aims to include 20 severe VKC patients who were not responding to conventional treatments. All the patients will be treated with 0.1% tacrolimus suspension two times daily, LE/T eye drops four times daily for 1 month. Additionally, 0.1% olopatadine two times daily and preservative-free artificial tears four times daily will be used. After the first month, LE/T will be stopped, with other treatments continued for the last 5 months. Visual acuity and intraocular pressure (IOP) will be measured at enrollment and 1, 2, 3 and 6 months after treatment. Besides, 6 subjective symptoms and 6 clinical signs will be graded at each visit based on a 4-point scale. The primary endpoints are the change in symptoms and objective signs. Treatment failure will be recorded if extra corticosteroids were required.

Official Title
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A Novel Combined Therapy for Refractory Vernal Keratoconjunctivitis

Conditions
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Vernal Keratoconjunctivitis

Intervention / Treatment
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* Drug: Tacrolimus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: vernal keratoconjunctivitis patients resistant to conventional treatments Exclusion Criteria: Patients diagnosed with other coexisting eye disease; with a confirmed or possible pregnancy; younger than 5 years old; had presence of systemic diseases other than coexisting allergic rhinitis, asthma, and atopic dermatitis; reported hypersensitivity to tacrolimus

Ages Eligible for Study
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Minimum Age: 5 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tacrolimus and loteprednol etabonate/tobramycin<br>topical eye drops | Drug: Tacrolimus<br>* All the patients will be treated with 0.1% tacrolimus suspension two times daily, LE/T eye drops four times daily for 1 month. 0.1% tacrolimus will be continued for the last 5 months.<br>* Other names: loteprednol etabonate 0.5%/tobramycin 0.3% (LE/T);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change of objective ocular signs | doctors judge the change of conjunctival injection, conjunctival edema, papillae, cobblestone papillae, limbal inflammation and corneal epithelial staining | before treatment and 1, 2, 3 and 6 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change of Best corrected visual acuity | doctors measure the change of BCVA | before treatment and 1, 2, 3 and 6 months after treatment | 
| the change of intraocular pressure | doctors measure the change of BCVA | before treatment and 1, 2, 3 and 6 months after treatment | 
| the change of subjective ocular symptoms | patients report the change of itching, redness, burning, photophobia, grittiness, and mucus discharge | before treatment and 1, 2, 3 and 6 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Refractory Vernal Keratoconjunctivitis, 0.1% tacrolimus, loteprednol etabonate 0.5%/tobramycin 0.3%