Parasitic Ulcer Treatment Trial

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

Conditions

• Acanthamoeba Keratitis

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.

Sponsors & Collaborators

• Johns Hopkins University

  collaborator OTHER

• Oregon Health and Science University

  collaborator OTHER

• University of Illinois at Chicago

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• University of Pennsylvania

  collaborator OTHER

• Columbia University

  collaborator OTHER

• University of Iowa

  collaborator OTHER

• University of Florida

  collaborator OTHER

• Aravind Eye Care System

  collaborator OTHER

• Moorfields Eye Hospital NHS Foundation Trust

  collaborator OTHER

• Federal University of São Paulo

  collaborator OTHER

• National Eye Institute (NEI)

  collaborator NIH

• University of Miami

  collaborator OTHER

• Baylor College of Medicine

  collaborator OTHER

• University of Colorado Denver - Anschutz Medical Campus (UCD-AMC)

  collaborator UNKNOWN

• Jeremy Keenan, MD, MPH

  lead OTHER

Principal Investigators

• Jeremy Keenan, MD, MPH · Proctor Foundation, UCSF

• Gerami Seitzman, MD · Proctor Foundation, UCSF

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

8 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-07-01

Primary Completion

2029-07-31

Completion

2029-07-31

FDA Drug

Yes

Countries

• United States
• Brazil
• India
• United Kingdom

Study Locations