Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction II

NCT06271772 · tracked via the Priya Life Science India tracker

Sponsor

University of California, San Francisco

Phase

Phase 3

Started

2024-07-01

Last updated

2026-08-17

Condition(s) studied

Bacterial Keratitis

Investigational drug(s) / intervention(s)

Difluprednate OphthalmicRose BengalMoxifloxacin Ophthalmic

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.

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.

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.

Study summary

Rose Bengal Electromagnetic Activation with Green light for Infection Reduction II (REAGIR II) is a randomized, double-masked feasibility study. The purpose of this study is to determine differences in 6-month visual acuity between medical antimicrobial treatments alone versus antimicrobial treatment plus cross-linking with rose Bengal (RB-PDT).

Patients presenting to one of the Aravind Eye Hospitals in India or to the Federal University of São Paulo ophthalmology clinic in Brazil with smear-positive and/or culture positive typical (I.e. non-Nocardia or Mycobacteria) bacterial corneal ulcers and moderate to severe vision loss, defined as Snellen visual acuity of 20/40 of worse, will be eligible for inclusion. Those who agree to participate will be randomized to one of two treatment groups:

* Group 6, RB-PDT Plus Early Steroids: topical 0.5% moxifloxacin plus topical difluprednate 0.05% plus RB-PDT
* Group 7, Sham RB-PDT Plus Early Steroids: topical 0.5% moxifloxacin plus topical difluprednate 0.05% plus sham RB-PDT

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Corneal ulcer that is smear positive and/or culture positive (within 24 hours) for typical bacteria (i.e. non-Nocardia or Myobacteria) * Moderate to severe vision loss, defined as Snellen visual acuity of 20/40 (6/12) or worse * Corneal thickness ≥350 µm, as measured on AS-OCT * Age over 18 years * Basic understanding of the study as determined by the physician * Commitment to return for follow up visits Exclusion Criteria: * Evidence of concomitant infection on exam, gram stain, or confocal microscopy (i.e. herpes, both bacteria and acanthamoeba on gram stain) * Impending or frank perforation at recruitment * Involvement of sclera at presentation * Presence of desmetocele at recruitment * Non-infectious or autoimmune keratitis * History of corneal transplantation * History of intraocular surgery within the last three months\* * Pinhole visual acuity worse than 20/200 in the unaffected eye * Participants who are decisionally and/or cognitively impaired

Primary outcome measure(s)

Best Spectacle-Corrected Visual Acuity — 6 months
Best Spectacle-Corrected Visual Acuity

Trial sites (2)

Facility	City	Region	Status
Federal University of São Paulo	São Paulo	Brazil
Aravind Eye Care System	Madurai	Tamil Nadu

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06271772 on ClinicalTrials.gov ↗ ← All trials in India