330
Participants
Start Date
August 3, 2022
Primary Completion Date
December 14, 2024
Study Completion Date
June 30, 2025
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.
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.
Natamycin
Natamycin 5% is an antifungal agent used to treat fungi that cause keratitis. This is a standard therapy for fungal keratitis.
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.
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.
Federal University of São Paulo, São Paulo
Aravind Eye Care System, Madurai
Aravind Eye Care System
OTHER
National Eye Institute (NEI)
NIH
Stanford University
OTHER
Federal University of São Paulo
OTHER
University of California, San Francisco
OTHER