Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction II

PHASE3RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

July 1, 2024

Primary Completion Date

June 1, 2026

Study Completion Date

December 31, 2026

Conditions
Bacterial Keratitis
Interventions
DRUG

Difluprednate Ophthalmic

Difluprednate 0.05% is a corticosteroid used to reduce inflammation in the eye. Participants will receive one drop of 0.05% difluprednate four times daily beginning 24 hours after the initiation of antibiotics for 1 week, decreased by 1 drop weekly for a total of 4 weeks of steroid therapy.

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 3-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.

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.

Trial Locations (2)

Unknown

RECRUITING

Federal University of São Paulo, São Paulo

RECRUITING

Aravind Eye Care System, Madurai

All Listed Sponsors
collaborator

Stanford University

OTHER

collaborator

Aravind Eye Care System

OTHER

collaborator

Federal University of São Paulo

OTHER

lead

University of California, San Francisco

OTHER