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Active, Not Recruiting

NCT Number: NCT06271772

Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction II

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Bacterial Keratitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Federal University of São Paulo, São Paulo, Brazil

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Difluprednate Ophthalmic

Drug

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

Drug

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.

Other names: Corneal Cross Linking with rose Bengal

Moxifloxacin Ophthalmic

Drug

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

Primary outcomes

  1. Best Spectacle-Corrected Visual Acuity

    Time frame: 6 months

    Best Spectacle-Corrected Visual Acuity

Secondary outcomes

  1. Best Spectacle-Corrected Visual Acuity

    Time frame: 3 Weeks, 3 Months, 12 Months

    Best Spectacle-Corrected Visual Acuity

  2. Scar size

    Time frame: 3 Weeks, 3 Months, 6 Months 12 Months

    Geometric mean

  3. Scar depth

    Time frame: 3 Weeks, 3 Months, 6 Months 12 Months

    Geometric mean

  4. Adverse Events

    Time frame: 12 Months

    Adverse Events

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Aravind Eye Care System
  • Federal University of São Paulo
  • Stanford University

Registry information

Acronym: REAGIR II

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 22, 2024
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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