NCT06213649

Parasitic Ulcer Treatment Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 232 (estimated)
• Sponsor: Jeremy Keenan, MD, MPH · Academic / Other
• Sex: All
• Age: 8 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-07-01
• Primary completion: 2028-07-01
• Completion: 2028-07-01
• First posted: 2024-01-19
• Last updated: 2026-01-28

Locations

16 sites across 4 countries: United States, Brazil, India, United Kingdom

Regulatory

• FDA-regulated drug study