A Novel Combined Therapy for Refractory Vernal Keratoconjunctivitis

NCT03464435 PHASE4 COMPLETED

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.

Details

Lead sponsor	Zhongshan Ophthalmic Center, Sun Yat-sen University
Phase	PHASE4
Status	COMPLETED
Enrolment	20
Start date	Tue Nov 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Thu Feb 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Vernal Keratoconjunctivitis

Interventions

• Tacrolimus