Vigamox Treatment for Ocular Graft-Versus-Host Disease

Phase 2

Withdrawn

• Conditions: Ocular Graft-versus-host Disease
• Interventions: Drug: Placebo; Drug: Vigamox

• Registration Number: NCT04204122
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-10
• Study First Submitted QC: 2019-12-16
• Study First Posted: 2019-12-18
• Study Start: 2020-06-15
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-03
• Last Update Posted: 2023-08-08
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2: Eye treated with placebo	Placebo	-The participant will be instructed to use one drop from each bottle four times per day for 7 days
Arm 1: Eye treated with Vigamox	Vigamox	-The participant will be instructed to use one drop from each bottle four times per day for 7 days

Primary Outcome Measures

Name	Time	Method
Change in Ocular comfort	First clinic visit through second clinic visit (estimated to be 9-14 days)	* 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

Name	Time	Method
Change in Ocular Surface Disease Index (OSDI) score	First clinic visit through second clinic visit (estimated to be 9-14 days)	* 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	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)	-The degree of conjunctival injection will be graded based on the Validated Bulbar Redness scale
Change in Corneal/conjunctival punctate epithelial erosions	First clinic visit through second clinic visit (estimated to be 9-14 days)	* 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	First clinic visit through second clinic visit (estimated to be 9-14 days)	-Conjunctival bacterial cultures will be obtained via swab before and after treatment