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NCT06213649 · ClinicalTrials.gov registry record · Phase 3

Parasitic Ulcer Treatment Trial

A Phase 3 study of Acanthamoeba Keratitis, sponsored by Jeremy Keenan, MD, MPH.

Recruiting
Registry status
Phase 3
Development phase
232
Enrollment target
16
Study locations

NCT06213649: Recruiting Phase 3 study of Acanthamoeba Keratitis, sponsored by Jeremy Keenan, MD, MPH.

NCT06213649 is a Phase 3 study of Acanthamoeba Keratitis that is actively recruiting participants, run by Jeremy Keenan, MD, MPH. The registered enrollment target is 232 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower). The trial reports 16 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06213649, a Phase 3 study of Acanthamoeba Keratitis, is actively recruiting participants, sponsored by Jeremy Keenan, MD, MPH.

RECRUITING
Registry status
Phase 3
Development phase
232 participants
Enrollment target
16
Study locations

Study 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

Primary Outcome

Best corrected visual acuity

Conditions Studied

Interventions

  • DRUG Polyhexamethylene biguanide (PHMB)
  • DRUG Topical corticosteroid
  • OTHER Topical placebo

Study Locations (16)

Florida

  • University of Florida - Gainesville
  • University of Miami - Miami

Pennsylvania

  • University of Pennsylvania - Philadelphia
  • University of Pittsburgh Medical Center - Pittsburgh

Other

  • Federal University of São Paulo - São Paulo
  • Moorfields Eye Hospital - London

Tamil Nadu

  • Aravind Eye Hospital - Coimbatore
  • Aravind Eye Hospital - Madurai

California

  • University of California, San Francisco - San Francisco

Illinois

  • University of Illinois, Chicago - Chicago

Iowa

  • University of Iowa - Iowa City

Maryland

  • Johns Hopkins University - Baltimore

Trial Details

FieldValue
Enrollment Target 232 participants
Start Date 2024-07-01
Est. Completion 2028-07
Phase Phase 3
Jeremy Keenan, MD, MPH

1 total trials

What NCT06213649 shows while recruiting

NCT06213649 is an interventional study that assigns participants to a tested intervention. The registered 232 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower).

The record links to 1 condition, with Acanthamoeba Keratitis appearing as the primary indexed condition, and to 3 interventions - of which Polyhexamethylene biguanide (PHMB) is the first listed.

NCT06213649 lists 16 locations in 12 states (Florida, Pennsylvania, Other).

Frequently Asked Questions

What is clinical trial NCT06213649 about?

NCT06213649 is a clinical study titled "Parasitic Ulcer Treatment Trial". 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...

What is the current status of trial NCT06213649?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 232 participants. The study started on 2024-07-01. Estimated completion is 2028-07.

What conditions does trial NCT06213649 study?

This clinical trial studies the following conditions: Acanthamoeba Keratitis.

What interventions are being tested in trial NCT06213649?

The interventions under investigation include: Polyhexamethylene biguanide (PHMB) (DRUG), Topical corticosteroid (DRUG), Topical placebo (OTHER).

Who is sponsoring clinical trial NCT06213649?

This trial is sponsored by Jeremy Keenan, MD, MPH, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06213649 being conducted?

This trial has 16 study locations across California, Florida, Illinois, Iowa, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT06213649's enrollment target sits among peer trials

232 1299th of 2000 higher than 701 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06213649, the US trial registry maintained by the National Library of Medicine. NCT06213649 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.