Clinical Research Directory
Browse clinical research sites, groups, and studies.
Parasitic Ulcer Treatment Trial
Sponsor: Jeremy Keenan, MD, MPH
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
Key Details
Gender
All
Age Range
8 Years - Any
Study Type
INTERVENTIONAL
Enrollment
232
Start Date
2024-07-01
Completion Date
2028-07
Last Updated
2026-01-28
Healthy Volunteers
No
Conditions
Interventions
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.
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.
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.
Locations (16)
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
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Baylor College of Medicine
Houston, Texas, United States
University of Washington
Seattle, Washington, United States
Federal University of São Paulo
São Paulo, Brazil
Aravind Eye Hospital
Coimbatore, Tamil Nadu, India
Aravind Eye Hospital
Madurai, Tamil Nadu, India
Moorfields Eye Hospital
London, United Kingdom