A Novel Combined Therapy for Refractory Vernal Keratoconjunctivitis

Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University (Other)

Overall Status

Completed

CT.gov ID

NCT03464435

Collaborator

(none)

Enrollment

Arm

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Vernal Keratoconjunctivitis	Drug: Tacrolimus	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Novel Combined Therapy for Refractory Vernal Keratoconjunctivitis

Actual Study Start Date :

Nov 1, 2016

Actual Primary Completion Date :

Nov 1, 2017

Actual Study Completion Date :

Feb 1, 2018

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

the change of objective ocular signs [before treatment and 1, 2, 3 and 6 months after treatment]
doctors judge the change of conjunctival injection, conjunctival edema, papillae, cobblestone papillae, limbal inflammation and corneal epithelial staining

Secondary Outcome Measures

the change of Best corrected visual acuity [before treatment and 1, 2, 3 and 6 months after treatment]
doctors measure the change of BCVA
the change of intraocular pressure [before treatment and 1, 2, 3 and 6 months after treatment]
doctors measure the change of BCVA
the change of subjective ocular symptoms [before treatment and 1, 2, 3 and 6 months after treatment]
patients report the change of itching, redness, burning, photophobia, grittiness, and mucus discharge

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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