Vigamox Treatment for Ocular Graft-Versus-Host Disease

NCT04204122 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 202003066
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ocular Graft-versus-host Disease

Keywords

GVHD; Graft-Versus-Host Disease; Ocular Surface; Ocular Surface Microbiome; Vigamox

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in Ocular Surface Disease Index (OSDI) score

  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

  First clinic visit through second clinic visit (estimated to be 9-14 days)

• Change in Corneal/conjunctival punctate epithelial erosions

  First clinic visit through second clinic visit (estimated to be 9-14 days)

• Change in Culture results

  First clinic visit through second clinic visit (estimated to be 9-14 days)

Study Arms (2)

Arm 1: Eye treated with Vigamox

EXPERIMENTAL

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

Drug: Vigamox

Arm 2: Eye treated with placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Vigamox DRUG

-FDA approved medication

Also known as: Moxifloxacin

Arm 1: Eye treated with Vigamox

Placebo DRUG

-The placebo is artificial tear drops

Arm 2: Eye treated with placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Related Links

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

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Todd Margolis, M.D., Ph.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 18, 2019
• Study Start: June 15, 2020
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: August 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share