A Novel Combined Therapy for Refractory Vernal Keratoconjunctivitis

NCT03464435 | Completed Phase 4

• 1 other identifier: ZOC2017001123
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Vernal Keratoconjunctivitis

Keywords

Refractory Vernal Keratoconjunctivitis; 0.1% tacrolimus; loteprednol etabonate 0.5%/tobramycin 0.3%

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• the change of Best corrected visual acuity

  before treatment and 1, 2, 3 and 6 months after treatment

• the change of intraocular pressure

  before treatment and 1, 2, 3 and 6 months after treatment

• the change of subjective ocular symptoms

  before treatment and 1, 2, 3 and 6 months after treatment

Study Arms (1)

tacrolimus and loteprednol etabonate/tobramycin

EXPERIMENTAL

topical eye drops

Drug: Tacrolimus

Interventions

Tacrolimus DRUG

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.

Also known as: loteprednol etabonate 0.5%/tobramycin 0.3% (LE/T)

tacrolimus and loteprednol etabonate/tobramycin

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• vernal keratoconjunctivitis patients resistant to conventional treatments

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

Tacrolimus; Loteprednol Etabonate

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: March 14, 2018
• Study Start: November 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: February 1, 2018
• Last Updated: March 14, 2018

Record last verified: 2018-03