Ocular Graft-versus-host Disease
Conditions
Keywords
GVHD, Graft-Versus-Host Disease, Ocular Surface, Ocular Surface Microbiome, Vigamox
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.
Interventions
DRUGVigamox
-FDA approved medication
DRUGPlacebo
-The placebo is artificial tear drops
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed