Vigamox Treatment for Ocular Graft-Versus-Host Disease

Ocular Graft-versus-host Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04204122
• Other study ID #: 202003066
• Status: Withdrawn
• Phase: Phase 2
• Start date: June 15, 2020
• Est. completion date: March 31, 2025

Study information

• Verified date: August 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Graft vs Host Disease
• Ocular Graft-versus-host Disease

Intervention

Drug:
• Vigamox
-FDA approved medication
• Placebo
-The placebo is artificial tear drops

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Change in Visual acuity		First clinic visit through second clinic visit (estimated to be 9-14 days)
Secondary	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)
Secondary	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)
Secondary	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)

External Links

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