search
Back to results

A Novel Combined Therapy for Refractory Vernal Keratoconjunctivitis

Primary Purpose

Vernal Keratoconjunctivitis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Tacrolimus
Sponsored by
Zhongshan Ophthalmic Center, Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vernal Keratoconjunctivitis focused on measuring Refractory Vernal Keratoconjunctivitis, 0.1% tacrolimus, loteprednol etabonate 0.5%/tobramycin 0.3%

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    tacrolimus and loteprednol etabonate/tobramycin

    Arm Description

    topical eye drops

    Outcomes

    Primary Outcome Measures

    the change of objective ocular signs
    doctors judge the change of conjunctival injection, conjunctival edema, papillae, cobblestone papillae, limbal inflammation and corneal epithelial staining

    Secondary Outcome Measures

    the change of Best corrected visual acuity
    doctors measure the change of BCVA
    the change of intraocular pressure
    doctors measure the change of BCVA
    the change of subjective ocular symptoms
    patients report the change of itching, redness, burning, photophobia, grittiness, and mucus discharge

    Full Information

    First Posted
    March 7, 2018
    Last Updated
    March 7, 2018
    Sponsor
    Zhongshan Ophthalmic Center, Sun Yat-sen University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03464435
    Brief Title
    A Novel Combined Therapy for Refractory Vernal Keratoconjunctivitis
    Official Title
    A Novel Combined Therapy for Refractory Vernal Keratoconjunctivitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    November 1, 2016 (Actual)
    Primary Completion Date
    November 1, 2017 (Actual)
    Study Completion Date
    February 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Zhongshan Ophthalmic Center, Sun Yat-sen University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vernal Keratoconjunctivitis
    Keywords
    Refractory Vernal Keratoconjunctivitis, 0.1% tacrolimus, loteprednol etabonate 0.5%/tobramycin 0.3%

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    tacrolimus and loteprednol etabonate/tobramycin
    Arm Type
    Experimental
    Arm Description
    topical eye drops
    Intervention Type
    Drug
    Intervention Name(s)
    Tacrolimus
    Other Intervention Name(s)
    loteprednol etabonate 0.5%/tobramycin 0.3% (LE/T)
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    the change of objective ocular signs
    Description
    doctors judge the change of conjunctival injection, conjunctival edema, papillae, cobblestone papillae, limbal inflammation and corneal epithelial staining
    Time Frame
    before treatment and 1, 2, 3 and 6 months after treatment
    Secondary Outcome Measure Information:
    Title
    the change of Best corrected visual acuity
    Description
    doctors measure the change of BCVA
    Time Frame
    before treatment and 1, 2, 3 and 6 months after treatment
    Title
    the change of intraocular pressure
    Description
    doctors measure the change of BCVA
    Time Frame
    before treatment and 1, 2, 3 and 6 months after treatment
    Title
    the change of subjective ocular symptoms
    Description
    patients report the change of itching, redness, burning, photophobia, grittiness, and mucus discharge
    Time Frame
    before treatment and 1, 2, 3 and 6 months after treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Learn more about this trial

    A Novel Combined Therapy for Refractory Vernal Keratoconjunctivitis

    We'll reach out to this number within 24 hrs