A Novel Combined Therapy for Refractory Vernal Keratoconjunctivitis

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.

Study Overview

• Status: Completed
• Conditions: Vernal Keratoconjunctivitis
• Intervention / Treatment: Drug: Tacrolimus

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tacrolimus and loteprednol etabonate/tobramycin; topical eye drops	Drug: Tacrolimus; 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.; Other Names: loteprednol etabonate 0.5%/tobramycin 0.3% (LE/T)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: March 7, 2018
• First Submitted That Met QC Criteria: March 7, 2018
• First Posted (Actual): March 14, 2018

Study Record Updates

• Last Update Posted (Actual): March 14, 2018
• Last Update Submitted That Met QC Criteria: March 7, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Refractory Vernal Keratoconjunctivitis; 0.1% tacrolimus; loteprednol etabonate 0.5%/tobramycin 0.3%
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Hypersensitivity; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Conjunctivitis, Allergic; Keratoconjunctivitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Anti-Allergic Agents; Calcineurin Inhibitors; Loteprednol Etabonate; Tacrolimus; Tobramycin
• Other Study ID Numbers: ZOC2017001123

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No