A Novel Combined Therapy for Refractory Vernal Keratoconjunctivitis

Vernal Keratoconjunctivitis Clinical Trial

Official title:

A Novel Combined Therapy for Refractory Vernal Keratoconjunctivitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03464435
• Other study ID #: ZOC2017001123
• Status: Completed
• Phase: Phase 4
• First received: March 7, 2018
• Last updated: March 7, 2018
• Start date: November 1, 2016
• Est. completion date: February 1, 2018

Study information

• Verified date: March 2018
• Source: Zhongshan Ophthalmic Center, Sun Yet-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 1, 2018
• Est. primary completion date: November 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Conjunctivitis, Allergic
• Keratoconjunctivitis
• Vernal Keratoconjunctivitis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhongshan Ophthalmic Center, Sun Yet-sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	the change of Best corrected visual acuity	doctors measure the change of BCVA	before treatment and 1, 2, 3 and 6 months after treatment
Secondary	the change of intraocular pressure	doctors measure the change of BCVA	before treatment and 1, 2, 3 and 6 months after treatment
Secondary	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