Vigamox Treatment for Ocular Graft-Versus-Host Disease

Sponsor

Washington University School of Medicine (Other)

Overall Status

Recruiting

CT.gov ID

NCT04204122

Collaborator

(none)

Enrollment

Location

Arms

49.5

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ocular Graft-versus-host Disease	Drug: Vigamox Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 15, 2020

Anticipated Primary Completion Date :

Jul 31, 2024

Anticipated Study Completion Date :

Jul 31, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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