Ocular Graft-versus-host Disease Clinical Trial
Official title:
Evaluation of Topical Vigamox in the Initial Management of Ocular Graft-Versus-Host Disease
Verified date | August 2023 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Washington University School of Medicine |
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) |
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