RECRUITING Phase 3 ClinicalTrials.gov

Parasitic Ulcer Treatment Trial

Sponsor: Jeremy Keenan, MD, MPH • ClinicalTrials.gov ID: NCT06213649

Registry updated: 2026-10-01

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Description

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

Interventions

Polyhexamethylene biguanide (PHMB) (Drug)
PHMB is a cationic antiseptic agent used for topical treatment of acanthamoeba keratitis (AK). Both treatment groups will take PHMB at least 4 times daily while on the allocated study drug.
Topical corticosteroid (Drug)
Dexamethasone sodium phosphate, 0.1% ophthalmic solution will be administered 4 times daily for 4 weeks, then 2 times daily for 2 weeks, then 1 time daily for 2 weeks.
Topical placebo (Other)
An artificial tear ophthalmic solution will be administered 4 times daily for 4 weeks, then 2 times daily for 2 weeks, then 1 time daily for 2 weeks.

Eligibility criteria

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

Conditions

Acanthamoeba Keratitis

Locations

University of California Irvine — Irvine, California, United States
University of California Los Angeles — Los Angeles, California, United States
University of California, San Francisco — San Francisco, California, United States
University of Colorado Anschutz — Aurora, Colorado, United States
University of Florida — Gainesville, Florida, United States
University of Miami — Miami, Florida, United States
University of South Florida — Orlando, Florida, United States
University of Illinois, Chicago — Chicago, Illinois, United States
University of Iowa — Iowa City, Iowa, United States
Johns Hopkins University — Baltimore, Maryland, United States
New York Eye and Ear Infirmary — New York, New York, United States
Columbia University — New York, New York, United States
Devers Eye Institute — Portland, Oregon, United States
Oregon Health and Science University — Portland, Oregon, United States
University of Pennsylvania — Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
Baylor College of Medicine — Houston, Texas, United States
University of Washington — Seattle, Washington, 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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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