Overview

A Novel Combined Therapy for Refractory Vernal Keratoconjunctivitis

Status:
Completed

Trial end date:
2018-02-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Zhongshan Ophthalmic Center, Sun Yat-sen University

Treatments:

Loteprednol Etabonate
Tacrolimus
Tobramycin

Criteria

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