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NCT06213649PHASE3Recruiting

Parasitic Ulcer Treatment Trial

Jeremy Keenan, MD, MPH

Start Date

7/1/2024

Completion Date

7/1/2029

Summary

The Parasitic Ulcer Treatment Trial (PUTT) is a multi-center, parallel-group, randomized clinical trial. The purpose of this study is to determine whether including topical corticosteroids in a regimen for acanthamoeba keratitis (AK) will improve vision. Patients presenting to all enrollment centers with evidence of acanthamoeba keratitis will be eligible for the trial if there is evidence of ocular inflammation after 4 weeks of anti-amoebic therapy. Those who agree to participate will be randomized to one of two treatment groups: * Group 1: Topical corticosteroid * Group 2: Topical placebo

Eligibility Criteria

Age Range: 8 years to No maximum

Inclusion Criteria: * AK on at least one of the following: culture, smear, PCR, shotgun sequencing, biopsy, or confocal microscopy * Ocular inflammation after 1 month of anti-amoebic treatment, defined as conjunctival, corneal, episcleral, or anterior chamber inflammation Exclusion Criteria: * Evidence or history of interstitial keratitis * Known herpetic keratitis, as determined from history, exam, or microbiological testing * Known fungal keratitis, as demonstrated from corneal scrapings * Corneal perforation or impending corneal perforation * Prior therapeutic keratoplasty for acanthamoeba keratitis * Unwillingness or inability to follow-up * No light perception in the affected eye * Known hypertensive response to steroids * Corticosteroid allergy * Concurrent treatment with systemic corticosteroids * Concurrent granulomatous amoebic encephalitis

Interventions

DRUG

Polyhexamethylene biguanide (PHMB)

DRUG

Topical corticosteroid

OTHER

Topical placebo

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Conditions

Acanthamoeba Keratitis

Locations

University of California, San Francisco

San Francisco, California 94158

United States

University of Colorado Anschutz

Aurora, Colorado 80045

United States

University of Florida

Gainesville, Florida 32605

United States

University of Miami

Miami, Florida 33136

United States

University of Illinois, Chicago

Chicago, Illinois 60612

United States

University of Iowa

Iowa City, Iowa 52242

United States

Johns Hopkins University

Baltimore, Maryland 21287

United States

Columbia University

New York, New York 10032

United States

Oregon Health and Science University

Portland, Oregon 97239

United States

University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania 15219

United States

Baylor College of Medicine

Houston, Texas 77030

United States

University of Washington

Seattle, Washington 98104

United States

Federal University of São Paulo

São Paulo,

Brazil

Aravind Eye Hospital

Coimbatore, Tamil Nadu

India

Aravind Eye Hospital

Madurai, Tamil Nadu

India

Moorfields Eye Hospital

London,

United Kingdom