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Antibiotic

Vigamox for Graft Versus Host Disease of the Eye

Phase 2

Waitlist Available

Led By Todd Margolis, M.D., Ph.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first clinic visit through second clinic visit (estimated to be 9-14 days)

Awards & highlights

Study Summary

This trial is testing whether the antibiotic Vigamox can treat ocular GVHD. One eye of each patient will be treated with Vigamox, while the other eye will be treated with a placebo. The results will help determine if Vigamox can be used to treat ocular GVHD.

Eligible Conditions

Graft Versus Host Disease (GVHD) of the Eye

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

You are an adult who has received a special type of stem cell transplant from another person and are currently experiencing eye problems related to the transplant. These eye problems started within the past 4 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first clinic visit through second clinic visit (estimated to be 9-14 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first clinic visit through second clinic visit (estimated to be 9-14 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and first clinic visit through second clinic visit (estimated to be 9-14 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Ocular comfort

Secondary outcome measures

Change in Corneal/conjunctival punctate epithelial erosions

Change in Culture results

Change in Ocular Surface Disease Index (OSDI) score

+2 more

Side effects data

From 2017 Phase 2 trial • 150 Patients • NCT02980523

Irritant conjunctivitis

stomachache

urinary tract infection (ITU)

Dysgeusia

100%

80%

60%

40%

20%

Study treatment Arm

Moxifloxacin (Vigamox®)

Gatifloxacin (Zymar®)

PRO-157 BID (2 Times Per Day)

PRO-157 TID (3 Times Per Day)

PRO-157 QID (4 Times Per Day)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm 1: Eye treated with VigamoxExperimental Treatment1 Intervention

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

Group II: Arm 2: Eye treated with placeboPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vigamox

2008

Completed Phase 4

~180

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,929 Previous Clinical Trials

2,297,959 Total Patients Enrolled

Todd Margolis, M.D., Ph.D.Principal InvestigatorWashington University School of Medicine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any similar investigations to the Vigamox study?

"As of right now, there are 26 Vigamox trials underway with 13 of them being in Phase 3. The hub for these studies appears to be Redwood City, California; however, there are 488 total study sites for Vigamox."

Answered by AI

Are participants still being enrolled for this experiment?

"Presently, this clinical trial is seeking participants, as noted on clinicaltrials.gov. This research was initially posted on 6/15/2020, with the most recent update taking place on 1/12/2022."

Answered by AI

What is the Vigamox FDA status?

"While Vigamox has not yet been proven effective, it has shown some promise in terms of safety, and thus received a score of 2."

Answered by AI

Which eye conditions does Vigamox help to treat?

"Vigamox is most often prescribed to treat bacterial pink eye. Additionally, it can also be used as an ocular antibacterial, to prevent the plague, and to manage postoperative infections."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Vigamox Treatment for Ocular Graft-Versus-Host Disease

2020. "Vigamox Treatment for Ocular Graft-Versus-Host Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04204122.