Bacterial KeratitisPhase 3REAGIR IINCT06271772
Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction II
A Phase 3 study testing Difluprednate Ophthalmic, Rose Bengal and Moxifloxacin Ophthalmic in people with Bacterial Keratitis, run by University of California, San Francisco at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacterial Keratitis
- What is being tested?
- Difluprednate Ophthalmic, Rose Bengal and Moxifloxacin Ophthalmic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jul 2024to 28 Feb 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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
- Conditions
- Bacterial Keratitis
- Being tested
- Difluprednate Ophthalmic, Rose Bengal, Moxifloxacin Ophthalmic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Difluprednate OphthalmicDrug
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 BengalDrug
Also called Corneal Cross Linking with 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 OphthalmicDrug
Topical moxifloxacin 0.5% is a fluoroquinolone antibiotic that is used to treat bacterial infections. This is a standard therapy for bacterial keratitis.
| Study group | Role | What they receive |
|---|---|---|
| RB-PDT Plus Early Steroids | Experimental | Not described Receives: Drug: Difluprednate Ophthalmic; Drug: Rose Bengal; Drug: Moxifloxacin Ophthalmic |
| Sham RB-PDT Plus Early Steroids | Experimental | Not described Receives: Drug: Difluprednate Ophthalmic; Drug: Moxifloxacin Ophthalmic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Spectacle-Corrected Visual Acuity
Best Spectacle-Corrected Visual Acuity
Measured: 6 months
Secondary outcomes (4)
Best Spectacle-Corrected Visual Acuity
Best Spectacle-Corrected Visual Acuity
Measured: 3 Weeks, 3 Months, 12 Months
Scar size
Geometric mean
Measured: 3 Weeks, 3 Months, 6 Months 12 Months
Scar depth
Geometric mean
Measured: 3 Weeks, 3 Months, 6 Months 12 Months
Adverse Events
Adverse Events
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start1 Jul 2024
- Primary completion31 Jul 2026
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial KeratitisStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, Aravind Eye Care System, Federal University of São Paulo
- Responsible party
- Sponsor
- Investigators
- Jennifer Rose-Nussbaumer, MD, Principal investigator, Stanford UniversityThomas Lietman, MD, Principal investigator, University of California, San FranciscoNicole Varnado, MPH, Study director, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271772
- Sponsor's protocol ID
- 18-26045-RII
- Acronym
- REAGIR II
- Status last verified
- Aug 2026
- First submitted
- 14 Feb 2024
- Last updated
- 17 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction II
- ClinicalTrials.gov ID
- NCT06271772
- Acronym / sponsor ID
- REAGIR II / 18-26045-RII
- Conditions
- Bacterial Keratitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Stanford University, Aravind Eye Care System, Federal University of São Paulo
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 22 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RB-PDT Plus Early Steroids | Experimental | Drug: Difluprednate Ophthalmic, Drug: Rose Bengal, Drug: Moxifloxacin Ophthalmic |
| Sham RB-PDT Plus Early Steroids | Experimental | Drug: Difluprednate Ophthalmic, Drug: Moxifloxacin Ophthalmic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Difluprednate OphthalmicDifluprednate 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 | RB-PDT Plus Early Steroids, Sham RB-PDT Plus Early Steroids |
| Rose BengalAlso: Corneal Cross Linking with rose BengalStudy 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 | RB-PDT Plus Early Steroids |
| Moxifloxacin OphthalmicTopical moxifloxacin 0.5% is a fluoroquinolone antibiotic that is used to treat bacterial infections. This is a standard therapy for bacterial keratitis. | Drug | RB-PDT Plus Early Steroids, Sham RB-PDT Plus Early Steroids |
Primary outcome
Best Spectacle-Corrected Visual Acuity
Time frame: 6 months
Best Spectacle-Corrected Visual Acuity
4 secondary outcomes
Best Spectacle-Corrected Visual Acuity
Time frame: 3 Weeks, 3 Months, 12 Months
Scar size
Time frame: 3 Weeks, 3 Months, 6 Months 12 Months
Scar depth
Time frame: 3 Weeks, 3 Months, 6 Months 12 Months
Adverse Events
Time frame: 12 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Rose-Nussbaumer, MD principal investigator
Stanford University
Thomas Lietman, MD principal investigator
University of California, San Francisco
Nicole Varnado, MPH study director
Stanford University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Difluprednate Ophthalmic, Rose Bengal and Moxifloxacin Ophthalmic in people with Bacterial Keratitis, run by University of California, San Francisco at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil, India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Spectacle-Corrected Visual Acuity (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.