Vigamox Treatment for Ocular Graft-Versus-Host Disease

Evaluation of Topical Vigamox in the Initial Management of Ocular Graft-Versus-Host Disease

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.

Study Overview

• Status: Withdrawn
• Conditions: Ocular Graft-versus-host Disease
• Intervention / Treatment: Drug: Vigamox; Drug: Placebo

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Todd Margolis, M.D., Ph.D.; Phone Number: 314-362-3724; Email: margolist@wustl.edu
• Study Contact Backup: Name: Christine Martinez, M.D.; Phone Number: 248-535-5420; Email: christine.martinez@wustl.edu

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine
      • Contact: Todd Margolis, M.D., Ph.D.; Phone Number: 314-362-3724; Email: margolist@wustl.edu
      • Contact: Christine Martinez, M.D.; Phone Number: 248-535-5420; Email: christine.martinez@wustl.edu
      • Principal Investigator: Todd Margolis, M.D., Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Eye treated with Vigamox; -The participant will be instructed to use one drop from each bottle four times per day for 7 days	Drug: Vigamox; -FDA approved medication; Other Names: Moxifloxacin
Placebo Comparator: Arm 2: Eye treated with placebo; -The participant will be instructed to use one drop from each bottle four times per day for 7 days	Drug: Placebo; -The placebo is artificial tear drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	First clinic visit through second clinic visit (estimated to be 9-14 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	First clinic visit through second clinic visit (estimated to be 9-14 days)
Change in Visual acuity		First clinic visit through second clinic visit (estimated to be 9-14 days)
Change in the Degree of Conjunctival injection	-The degree of conjunctival injection will be graded based on the Validated Bulbar Redness scale	First clinic visit through second clinic visit (estimated to be 9-14 days)
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.	First clinic visit through second clinic visit (estimated to be 9-14 days)
Change in Culture results	-Conjunctival bacterial cultures will be obtained via swab before and after treatment	First clinic visit through second clinic visit (estimated to be 9-14 days)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Todd Margolis, M.D., Ph.D., Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2020
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: December 10, 2019
• First Submitted That Met QC Criteria: December 16, 2019
• First Posted (Actual): December 18, 2019

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Graft-Versus-Host Disease; GVHD; Vigamox; Ocular Surface; Ocular Surface Microbiome
• Additional Relevant MeSH Terms: Immune System Diseases; Graft vs Host Disease; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Moxifloxacin
• Other Study ID Numbers: 202003066

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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