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Investigator decided to close study
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Eye treated with Vigamox | Experimental | -The participant will be instructed to use one drop from each bottle four times per day for 7 days |
|
| Arm 2: Eye treated with placebo | Placebo Comparator | -The participant will be instructed to use one drop from each bottle four times per day for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vigamox | Drug | -FDA approved medication |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Ocular comfort |
| First clinic visit through second clinic visit (estimated to be 9-14 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Ocular Surface Disease Index (OSDI) score |
| First clinic visit through second clinic visit (estimated to be 9-14 days) |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Todd Margolis, M.D., Ph.D. | Washington University School of Medicine | Principal Investigator |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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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.
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| Placebo | Drug | -The placebo is artificial tear drops |
|
| Change in Visual acuity | First clinic visit through second clinic visit (estimated to be 9-14 days) |
| 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) |
| Change in Corneal/conjunctival punctate epithelial erosions |
| First clinic visit through second clinic visit (estimated to be 9-14 days) |
| 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) |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |