Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction

PHASE3CompletedINTERVENTIONAL
Enrollment

330

Participants

Timeline

Start Date

August 3, 2022

Primary Completion Date

December 14, 2024

Study Completion Date

June 30, 2025

Conditions
Acanthamoeba KeratitisFungal Keratitis
Interventions
DRUG

Moxifloxacin Ophthalmic

Topical moxifloxacin 0.5% is a fluoroquinolone antibiotic that is used to treat bacterial infections. This is a standard therapy for bacterial keratitis.

DRUG

Chlorhexidine Gluconate

Topical chlorhexidine gluconate 0.02% is an antiseptic agent, with both antibacterial and antifungal properties. This is a standard therapy for Acanthamoeba keratitis.

DRUG

Natamycin

Natamycin 5% is an antifungal agent used to treat fungi that cause keratitis. This is a standard therapy for fungal keratitis.

DRUG

Rose Bengal

Study participants receive RB-PDT within 48 hours of randomization. All participants will receive a 30-minute loading dose of topical Rose Bengal (0.1% RB in 0.9% sodium chloride) which will be applied in 5-minute intervals to the de-epithelialized cornea. This will be followed by irradiation with a 6mW/cm2 custom-made green LED source for 15 minutes (5.4J/cm2). Repeat cornea culture will be collected within 24 hours after the procedure.

OTHER

Placebo

Study participants receive sham RB-PDT within 48 hours of randomization. Participants will receive a 30-minute loading dose of topical balanced salt solution which will be applied in 5-minute intervals to the de-epithelialized cornea. A pen light covered with a green filter will be used for 15 minutes. Repeat cornea culture will be collected 30 minutes after the sham procedure.

Trial Locations (2)

Unknown

Federal University of São Paulo, São Paulo

Aravind Eye Care System, Madurai

All Listed Sponsors
collaborator

Aravind Eye Care System

OTHER

collaborator

National Eye Institute (NEI)

NIH

collaborator

Stanford University

OTHER

collaborator

Federal University of São Paulo

OTHER

lead

University of California, San Francisco

OTHER