A Novel Combined Therapy for Refractory Vernal Keratoconjunctivitis

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03464435
Study type	Interventional
Source	Zhongshan Ophthalmic Center, Sun Yet-sen University
Contact
Status	Completed
Phase	Phase 4
Start date	November 1, 2016
Completion date	February 1, 2018

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05076084` - Evaluation of the Efficacy and Safety of Tacrolimus Drops in Children With Vernal Keratoconjunctivitis
Recruiting	`NCT02057822` - Cytokine Assay in Tears of Healthy Children and With Vernal Keratoconjunctivitis: Case Control Study and Monitoring of Cases at 6 Months	N/A
Completed	`NCT00445120` - Lactobacillus Rhamnosus GG Oral Treatment Efficacy on Vernal Keratoconjunctivitis Treatment	Phase 2/Phase 3
Recruiting	`NCT03557203` - Dermatologic Tacrolimus Ointment on Eyelids in the Treatment of Refractory Vernal Keratoconjunctivitis and Atopic Keratoconjunctivitis
Completed	`NCT01211327` - Topical Cyclosporine for Vernal Keratoconjunctivitis (VKC) in Rwanda	Phase 4
Completed	`NCT05353101` - Cyclosporine 0.05% Eye Drops for Vernal Keratoconjunctivitis Trial	Phase 1
Not yet recruiting	`NCT04705584` - Topical Immuonosuppressant Drugs in Spring Catarrh	N/A
Completed	`NCT03379311` - A Study of AK002 in Patients With Atopic Keratoconjunctivitis, Vernal Keratoconjunctivitis, and Perennial Allergic Conjunctivitis	Phase 1
Completed	`NCT00426023` - Cyclosporin A Eye Drop Treatment in Vernal Keratoconjunctivitis	Phase 3
Completed	`NCT01751126` - Double-Masked Trial of NOVA22007 (1mg/mL Ciclosporin/Cyclosporine) Versus Vehicle in Pediatric Patients With Active Severe Vernal Keratoconjunctivitis	Phase 3
Recruiting	`NCT02456025` - Topical Tacrolimus in Vernal Keratoconjunctivitis	Phase 4