Parasitic Ulcer Treatment Trial (PUTT)

Jeremy Keenan, MD, MPH

Status and phase: Enrolling; Phase 3

Conditions: Acanthamoeba Keratitis

Treatments: Drug: Polyhexamethylene biguanide (PHMB); Other: Topical placebo; Drug: Topical corticosteroid

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06213649

UG1EY033284 (U.S. NIH Grant/Contract)

23-39559

Details and patient eligibility

About

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

Enrollment: 232 estimated patients

Sex: All

Ages: 8+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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232 participants in 2 patient groups, including a placebo group

Topical steroids

Experimental group

Description:

Participants in this arm will receive anti-amoebic therapy plus topical steroids.

Treatment:

Drug: Topical corticosteroid

Drug: Polyhexamethylene biguanide (PHMB)

Topical placebo

Placebo Comparator group

Description:

Participants in this arm will receive anti-amoebic therapy plus topical placebo.

Treatment:

Other: Topical placebo

Drug: Polyhexamethylene biguanide (PHMB)