Parasitic Ulcer Treatment Trial

PHASE3RecruitingINTERVENTIONAL
Enrollment

232

Participants

Timeline

Start Date

July 1, 2024

Primary Completion Date

July 31, 2028

Study Completion Date

July 31, 2028

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.

Trial Locations (14)

10032

NOT_YET_RECRUITING

Columbia University, New York

19104

NOT_YET_RECRUITING

University of Pennsylvania, Philadelphia

21287

NOT_YET_RECRUITING

Johns Hopkins University, Baltimore

32605

RECRUITING

University of Florida, Gainesville

33136

RECRUITING

University of Miami, Miami

52242

RECRUITING

University of Iowa, Iowa City

60612

RECRUITING

University of Illinois, Chicago, Chicago

90095

NOT_YET_RECRUITING

University of California, Los Angeles, Los Angeles

94158

RECRUITING

University of California, San Francisco, San Francisco

97239

RECRUITING

Oregon Health and Science University, Portland

Unknown

RECRUITING

Federal University of São Paulo, São Paulo

RECRUITING

Aravind Eye Hospital, Coimbatore

RECRUITING

Aravind Eye Hospital, Madurai

NOT_YET_RECRUITING

Moorfields Eye Hospital, London

All Listed Sponsors
collaborator

Johns Hopkins University

OTHER

collaborator

Oregon Health and Science University

OTHER

collaborator

University of Illinois at Chicago

OTHER

collaborator

University of California, Los Angeles

OTHER

collaborator

University of Pittsburgh

OTHER

collaborator

University of Pennsylvania

OTHER

collaborator

Columbia University

OTHER

collaborator

University of Iowa

OTHER

collaborator

University of Florida

OTHER

collaborator

Aravind Eye Care System

OTHER

collaborator

Moorfields Eye Hospital NHS Foundation Trust

OTHER

collaborator

Federal University of São Paulo

OTHER

collaborator

National Eye Institute (NEI)

NIH

collaborator

University of Miami

OTHER

lead

Jeremy Keenan, MD, MPH

OTHER