PUTT (PUTT)

Investigating Treatments for an Eye Condition

Recruiting
8 years or above
All
Phase 3
232 participants needed
1 Location

Brief description of study

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

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Acanthamoeba Keratitis
  • Age: 8 years or above
  • Gender: All

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

The purpose of this study is to investigate acanthamoeba keratitis. It evaluates whether including topical corticosteroids can improve vision in patients with this condition.

This study focuses on evaluating the effectiveness of topical corticosteroids in treating acanthamoeba keratitis. It looks at how these medications might affect vision improvement.

  • Who can participate: Participants must have acanthamoeba keratitis confirmed by specific tests and show ocular inflammation after one month of anti-amoebic treatment. Individuals with other eye conditions or allergies to corticosteroids are not eligible.
  • Study details: Participants will be randomly assigned to receive either a topical corticosteroid or a topical placebo. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine.
Updated on 01 May 2026. Study ID: 25-0911

Pre-Screener

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Has an eye doctor diagnosed you with acanthamoeba keratitis (AK) in the past month?

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