Parasitic Ulcer Treatment Trial Pilot

Phase 2 Completed 49 enrolled University of California, San Francisco Research to Prevent Blindness · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

This is a study of optimal treatments for acanthamoeba keratitis. In the first part of the study, participants will be randomized to chlorhexidine monotherapy or chlorhexidine plus povidone iodine. After four weeks of therapy, participants will be re-randomized to early corticosteroids, later corticosteroids, or placebo.

Timeline

Start: 2018-01-01
Primary completion: 2022-11-15
Completion: 2022-11-15

Outcome

Missed primary endpoint

paper The proportion of participants with a positive culture during the initial 4 weeks of antiamoebic treatment was not significantly different in the povidone-iodine group (6/18 [33%] at 4 weeks) and control group (5/16 [31%] at 4 weeks) (RR 0.90, 95%CI: 0.35-2.29; P = 0.82). PMID 41914638 ↗

Publications

Rajaraman R, Kassaye I, Sharma SS, Prajna NV, Lalitha P, Panigrahi A, Rammohan R, Aromin KM, Cook C, Porco TC, Lietman TM, Seitzman GD, Keenan JD. Adjunctive povidone-iodine for Acanthamoeba keratitis: a randomized trial. Antimicrob Agents Chemother. 2026 May 6;70(5):e0151225. doi: 10.1128/aac.01512-25. Epub 2026 Mar 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Chlorhexidine	Small molecule	0.04 %	Topical
Subject	Povidone-Iodine	Other / unclassified	2.5 %	Topical
Subject	Prednisolone	Other / unclassified	1 %	Topical