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Corticosteroid

PHMB + Topical Corticosteroids for Acanthamoeba Keratitis (PUTT Trial)

Phase 3
Recruiting
Research Sponsored by Jeremy Keenan, MD, MPH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ocular inflammation after 1 month of anti-amoebic treatment, defined as conjunctival, corneal, episcleral, or anterior chamber inflammation
Must not have
Concurrent treatment with systemic corticosteroids
Corneal perforation or impending corneal perforation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Pivotal Trial

Summary

This trial is called the Parasitic Ulcer Treatment Trial (PUTT) and it aims to find out if adding a specific type of medication called topical corticosteroids to the treatment for a condition

Who is the study for?
This trial is for patients with a parasitic eye infection called Acanthamoeba Keratitis, who still have inflammation after 4 weeks of initial treatment. They must not have other types of keratitis, corneal perforation, previous eye surgery for this condition, severe vision loss in the affected eye, steroid allergies or reactions, or be on systemic steroids.
What is being tested?
The PUTT aims to see if adding topical corticosteroids to the usual treatment improves vision in those with Acanthamoeba Keratitis and persistent inflammation. Participants will be randomly assigned to either receive a corticosteroid or a placebo eyedrop.
What are the potential side effects?
Topical corticosteroids may cause increased pressure inside the eye, cataracts over time, delayed healing of infections or injuries in the eye area and could potentially worsen existing infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have eye inflammation after a month of treatment for an amoeba infection.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking corticosteroids.
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My eye's cornea is at risk of or has a hole.
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I have a brain infection caused by amoebas.
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I have had a cornea transplant for acanthamoeba keratitis.
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I have had interstitial keratitis.
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I have been diagnosed with herpetic keratitis.
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I have been diagnosed with fungal keratitis from corneal scrapings.
Select...
I am unable to commit to follow-up visits.
Select...
I cannot see any light with my affected eye.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Vision
Secondary study objectives
Clinical Resolution
Multivariate Analysis
Self-reported eye pain

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Topical steroidsExperimental Treatment2 Interventions
Participants in this arm will receive anti-amoebic therapy plus topical steroids.
Group II: Topical placeboPlacebo Group2 Interventions
Participants in this arm will receive anti-amoebic therapy plus topical placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Topical corticosteroid
2018
Completed Phase 4
~1350

Find a Location

Who is running the clinical trial?

Jeremy Keenan, MD, MPHLead Sponsor
Johns Hopkins UniversityOTHER
2,331 Previous Clinical Trials
14,874,226 Total Patients Enrolled
University of MiamiOTHER
950 Previous Clinical Trials
428,168 Total Patients Enrolled
~155 spots leftby Jul 2028
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