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Parasitic Ulcer Treatment Trial

RecruitingPhase 3Ages 8 Years - anyAllJeremy Keenan, MD, MPH
NCT06213649 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Polyhexamethylene biguanide (PHMB)
  • Topical corticosteroid
  • Topical placebo
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Where

22 sites
University of California Irvine
Irvine, United States
University of California Los Angeles
Los Angeles, United States
University of California, San Francisco
San Francisco, United States
University of Colorado Anschutz
Aurora, United States
University of Florida
Gainesville, United States
University of Miami
Miami, United States
University of South Florida
Orlando, United States
University of Illinois, Chicago
Chicago, United States

…and 14 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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