Vigamox Treatment for Ocular Graft-Versus-Host Disease

The Washington University

Status and phase: Withdrawn; Phase 2

Conditions: Ocular Graft-versus-host Disease

Treatments: Drug: Placebo; Drug: Vigamox

Study type: Interventional

Funder types: Other

Identifiers

NCT04204122

202003066

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No 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

Exclusion criteria

• Treated with antibiotic eye drops in the month prior to enrollment
• History of fluoroquinolone allergy
• Asymmetric ocular disease
• Pregnant
• Nursing

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

Arm 1: Eye treated with Vigamox

Experimental group

Description:

-The participant will be instructed to use one drop from each bottle four times per day for 7 days

Treatment:

Drug: Vigamox

Arm 2: Eye treated with placebo

Placebo Comparator group

Description:

-The participant will be instructed to use one drop from each bottle four times per day for 7 days

Treatment:

Drug: Placebo