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Recruiting NCT06213649

Parasitic Ulcer Treatment Trial

Phase III Interventional Acanthamoeba Keratitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Polyhexamethylene biguanide (PHMB), Topical corticosteroid, Topical placebo.
Who it may be relevant to
Registry conditions: Acanthamoeba Keratitis. Basic parameters: from 8 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Brazil, India, United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Drug Polyhexamethylene biguanide (PHMB)
    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.
  • Drug Topical corticosteroid
    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.
  • Other Topical placebo
    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.

Primary outcome measures

  • Vision [Time frame: 6 Months]
Secondary outcome measures (3)
  • Self-reported eye pain [Time frame: 2 months]
  • Clinical Resolution [Time frame: 12 months]
  • Multivariate Analysis [Time frame: 6 Months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 13 centers
  • University of California, San Francisco — San Francisco
  • University of Colorado Anschutz — Aurora
  • University of Florida — Gainesville
  • University of Miami — Miami
  • University of Illinois, Chicago — Chicago
  • University of Iowa — Iowa City
  • Johns Hopkins University — Baltimore
  • Columbia University — New York
  • … and 5 more centers
India · 2 centers
  • Aravind Eye Hospital — Coimbatore
  • Aravind Eye Hospital — Madurai
Brazil · 1 center
  • Federal University of São Paulo — São Paulo
United Kingdom · 1 center
  • Moorfields Eye Hospital — London

Identifiers

NCT: NCT06213649 · 23-39559 · UG1EY033284

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗