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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04204122
Other study ID # 202003066
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date June 15, 2020
Est. completion date March 31, 2025

Study information

Verified date August 2023
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn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

Study Design


Intervention

Drug:
Vigamox
-FDA approved medication
Placebo
-The placebo is artificial tear drops

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Washington University School of Medicine

Outcome

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)
See also
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Not yet recruiting NCT06412718 - Validation of Human Drugs Target of Repurposed Drugs and Novel Therapies
Recruiting NCT06348602 - Evaluation of Safety & Efficacy for the Prevention of Ocular GVHD With Ophthalmic Tacrolimus vs Cyclosporine in Allo-HSCT Phase 1/Phase 2
Active, not recruiting NCT04769648 - Safety and Efficacy of Pro-ocular™ 1% in Daily Scleral Lens Wearing Patients With Ocular Graft-versus-Host Disease Phase 2/Phase 3
Recruiting NCT05311514 - Allogeneic Platelet Lysate Eye Drops for the Treatment of Severe Chronic Ocular Graft-versus-host Disease Phase 2