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Vigamox Treatment for Ocular Graft-Versus-Host Disease

Primary Purpose

Ocular Graft-versus-host Disease

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Vigamox
Placebo
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ocular Graft-versus-host Disease focused on measuring GVHD, Graft-Versus-Host Disease, Ocular Surface, Ocular Surface Microbiome, Vigamox

Eligibility Criteria

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

Inclusion Criteria:

-Participants will be adults with a history of allogeneic hematopoietic stem cell transplantation, signs of either acute or chronic GVHD per the hematologist, signs and symptoms consistent with ocular GVHD + within 4 months of developing symptoms of ocular GVHD

Exclusion Criteria:

  • Treated with antibiotic eye drops in the month prior to enrollment
  • History of fluoroquinolone allergy
  • Asymmetric ocular disease
  • Pregnant
  • Nursing

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Arm 1: Eye treated with Vigamox

    Arm 2: Eye treated with placebo

    Arm Description

    -The participant will be instructed to use one drop from each bottle four times per day for 7 days

    -The participant will be instructed to use one drop from each bottle four times per day for 7 days

    Outcomes

    Primary Outcome Measures

    Change in Ocular comfort
    Ocular comfort will be rated by the participant for each eye on a 0-10 Visual Analog Scale 0=no discomfort and 10=worst discomfort

    Secondary Outcome Measures

    Change in Ocular Surface Disease Index (OSDI) score
    12 questions with answers ranging from 0=none of the time to 4=all of the time The OSDI©is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease.
    Change in Visual acuity
    Change in the Degree of Conjunctival injection
    -The degree of conjunctival injection will be graded based on the Validated Bulbar Redness scale
    Change in Corneal/conjunctival punctate epithelial erosions
    The clinical exam will be conducted using the National Eye Institute Fluorescein Staining Scale to grade the degree of corneal and conjunctival stain with a cobalt blue slit lamp filter This test divides the cornea into 5 sections. Staining is graded on a scale of 0-3, with 0 indicating absence of staining and 3 indicating severe staining.
    Change in Culture results
    -Conjunctival bacterial cultures will be obtained via swab before and after treatment

    Full Information

    First Posted
    December 10, 2019
    Last Updated
    August 3, 2023
    Sponsor
    Washington University School of Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04204122
    Brief Title
    Vigamox Treatment for Ocular Graft-Versus-Host Disease
    Official Title
    Evaluation of Topical Vigamox in the Initial Management of Ocular Graft-Versus-Host Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Investigator decided to close study
    Study Start Date
    June 15, 2020 (Actual)
    Primary Completion Date
    March 31, 2025 (Anticipated)
    Study Completion Date
    March 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Washington University School of Medicine

    4. Oversight

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

    5. Study Description

    Brief Summary
    In this study the investigators seek to prospectively measure the response of ocular graft-versus-host disease (GVHD) patients to treatment with topical Vigamox. The investigators will accomplish this by enrolling patients with bilateral ocular GVHD and treating one eye with topical Vigamox and the other eye with a placebo eye drop. By assessing the response to treatment with Vigamox, the investigators hope to identify a role for topical antibiotic treatment in ocular GVHD.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ocular Graft-versus-host Disease
    Keywords
    GVHD, Graft-Versus-Host Disease, Ocular Surface, Ocular Surface Microbiome, Vigamox

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    The eyes of each enrolled participant will be randomized such that one eye is treated with Vigamox and the other eye is treated with a placebo eye drop.
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm 1: Eye treated with Vigamox
    Arm Type
    Experimental
    Arm Description
    -The participant will be instructed to use one drop from each bottle four times per day for 7 days
    Arm Title
    Arm 2: Eye treated with placebo
    Arm Type
    Placebo Comparator
    Arm Description
    -The participant will be instructed to use one drop from each bottle four times per day for 7 days
    Intervention Type
    Drug
    Intervention Name(s)
    Vigamox
    Other Intervention Name(s)
    Moxifloxacin
    Intervention Description
    -FDA approved medication
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    -The placebo is artificial tear drops
    Primary Outcome Measure Information:
    Title
    Change in Ocular comfort
    Description
    Ocular comfort will be rated by the participant for each eye on a 0-10 Visual Analog Scale 0=no discomfort and 10=worst discomfort
    Time Frame
    First clinic visit through second clinic visit (estimated to be 9-14 days)
    Secondary Outcome Measure Information:
    Title
    Change in Ocular Surface Disease Index (OSDI) score
    Description
    12 questions with answers ranging from 0=none of the time to 4=all of the time The OSDI©is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease.
    Time Frame
    First clinic visit through second clinic visit (estimated to be 9-14 days)
    Title
    Change in Visual acuity
    Time Frame
    First clinic visit through second clinic visit (estimated to be 9-14 days)
    Title
    Change in the Degree of Conjunctival injection
    Description
    -The degree of conjunctival injection will be graded based on the Validated Bulbar Redness scale
    Time Frame
    First clinic visit through second clinic visit (estimated to be 9-14 days)
    Title
    Change in Corneal/conjunctival punctate epithelial erosions
    Description
    The clinical exam will be conducted using the National Eye Institute Fluorescein Staining Scale to grade the degree of corneal and conjunctival stain with a cobalt blue slit lamp filter This test divides the cornea into 5 sections. Staining is graded on a scale of 0-3, with 0 indicating absence of staining and 3 indicating severe staining.
    Time Frame
    First clinic visit through second clinic visit (estimated to be 9-14 days)
    Title
    Change in Culture results
    Description
    -Conjunctival bacterial cultures will be obtained via swab before and after treatment
    Time Frame
    First clinic visit through second clinic visit (estimated to be 9-14 days)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: -Participants will be adults with a history of allogeneic hematopoietic stem cell transplantation, signs of either acute or chronic GVHD per the hematologist, signs and symptoms consistent with ocular GVHD + within 4 months of developing symptoms of ocular GVHD Exclusion Criteria: Treated with antibiotic eye drops in the month prior to enrollment History of fluoroquinolone allergy Asymmetric ocular disease Pregnant Nursing
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Todd Margolis, M.D., Ph.D.
    Organizational Affiliation
    Washington University School of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Links:
    URL
    http://www.siteman.wustl.edu
    Description
    Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

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    Vigamox Treatment for Ocular Graft-Versus-Host Disease

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