Parasitic Ulcer Treatment Trial

Phase 3

Recruiting

• Conditions: Acanthamoeba Keratitis
• Interventions: Drug: Polyhexamethylene biguanide (PHMB); Drug: Topical corticosteroid; Other: Topical placebo

• Registration Number: NCT06213649
• Lead Sponsor: Jeremy Keenan, MD, MPH

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-09
• Study First Submitted QC: 2024-01-09
• Study First Posted: 2024-01-19
• Study Start: 2024-07-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Primary Completion: 2028-07
• Study Completion: 2028-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 232

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Topical steroids	Polyhexamethylene biguanide (PHMB)	Participants in this arm will receive anti-amoebic therapy plus topical steroids.
Topical placebo	Polyhexamethylene biguanide (PHMB)	Participants in this arm will receive anti-amoebic therapy plus topical placebo.
Topical steroids	Topical corticosteroid	Participants in this arm will receive anti-amoebic therapy plus topical steroids.
Topical placebo	Topical placebo	Participants in this arm will receive anti-amoebic therapy plus topical placebo.

Primary Outcome Measures

Name	Time	Method
Vision	6 Months	Best corrected visual acuity

Secondary Outcome Measures

Name	Time	Method
Self-reported eye pain	2 months	Pain visual analog scale (Likert scale from 0 to 10; 0=no pain, 10=worst pain)
Clinical Resolution	12 months	Time until clinical resolution (i.e., healed ocular surface and absence of inflammation)
Multivariate Analysis	6 Months	The multivariate analysis will include the following outcomes measured at 6 months: best corrected visual acuity, corneal thinning on optical coherence tomography (OCT), scar density on Scheimpflug imaging, irregular astigmatism, glare, microbial clearance on confocal microscopy, pain score, time until clinical resolution

Trial Locations

Locations (13)

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

University of Miami; 🇺🇸 Miami, Florida, United States

University of Illinois, Chicago; 🇺🇸 Chicago, Illinois, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Columbia University; 🇺🇸 New York, New York, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Federal University of São Paulo; 🇧🇷 São Paulo, Brazil

Aravind Eye Hospital; 🇮🇳 Madurai, Tamil Nadu, India

Moorfields Eye Hospital; 🇬🇧 London, United Kingdom