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Parasitic Ulcer Treatment Trial

Study acronym: PUTT
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Trial sites expanded: 17 → 22 locations
    • Eligibility criteria expanded, about 13 words
    • Collaborators revised (15)
  2. Primary and study completion pushed from Jul 2028 to Jul 2029
    • Study sites: 16 to 17
    • Collaborators: 14 to 15
    v10
  3. Secondary endpoints: details revised at 1 of 3 entriesv9
  4. Study sites: 14 to 16v8
  5. Collaborators revised (14)v7
Show 5 earlier versionsHide 5 earlier versions
  1. Site details revised at 3 of 14 sitesv6
  2. Site details revised at 1 of 14 sites
    • Collaborators revised (14)
    v5
  3. Study sites: 13 to 14v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Apr 2028 to Jul 2028
    • Start date changed from estimate of Apr 2024 to Jul 1, 2024
    • Site details revised at 13 of 13 sites
    v3
  5. Secondary endpoints: details revised at 1 of 3 entriesv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06213649
Lead Sponsor Jeremy Keenan, MD, MPH
Collaborators: Johns Hopkins University, Oregon Health and Science University, University of Illinois at Chicago, University of Pittsburgh, University of Pennsylvania, Columbia University, University of Iowa, University of Florida, Aravind Eye Care System, Moorfields Eye Hospital NHS Foundation Trust, Federal University of São Paulo, National Eye Institute (NEI), University of Miami, Baylor College of Medicine, University of Colorado, Denver
Conditions
(from sponsor)		 Acanthamoeba Keratitis
Related terms Acanthamoeba Keratitis, Corneal Ulcer
Enrollment 232 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov