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Antiseptic

Rose Bengal + Light Therapy for Corneal Inflammation (REAGIR Trial)

Phase 3
Recruiting
Led By Tom Lietman, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age over 18 years
Moderate to severe vision loss, defined as Snellen visual acuity of 20/40 (6/12) or worse
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 weeks, 3 months, 6 months 12 months
Awards & highlights

REAGIR Trial Summary

This trial will compare two treatments for corneal ulcers: one standard medical treatment plus a new treatment using light therapy.

Who is the study for?
This trial is for adults over 18 with corneal infections like fungal or acanthamoeba keratitis, or negative smear/culture ulcers causing moderate to severe vision loss. Participants must understand the study and commit to follow-up visits. Those with other eye infections, recent eye surgery, very poor vision in the unaffected eye, or cognitive impairments cannot join.Check my eligibility
What is being tested?
The REAGIR trial tests if adding Rose Bengal Photodynamic Therapy (RB-PDT) to standard antimicrobial treatments improves visual acuity in patients with certain corneal infections. It's a randomized study where participants either receive RB-PDT or a sham treatment alongside their regular medication.See study design
What are the potential side effects?
Potential side effects may include discomfort at the site of application, light sensitivity due to rose Bengal activation, and typical reactions associated with ophthalmic medications such as redness, irritation, tearing or dry eyes.

REAGIR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 18 years old.
Select...
My vision is 20/40 or worse.

REAGIR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 weeks, 3 months, 6 months 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 weeks, 3 months, 6 months 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Adverse Events
Best Spectacle-Corrected Visual Acuity
Scar Depth
+1 more

REAGIR Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Cross-Linking with rose Bengal (RB-PDT)Experimental Treatment4 Interventions
Patients in this arm will receive topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus RB-PDT
Group II: Standard TherapyPlacebo Group4 Interventions
Patients in this arm will receive topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus sham RB-PDT
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rose Bengal
2015
N/A
~30
Moxifloxacin Ophthalmic
2011
Completed Phase 4
~180
Natamycin
2010
Completed Phase 3
~400
Chlorhexidine Gluconate
2014
Completed Phase 4
~2340

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,496 Previous Clinical Trials
11,934,359 Total Patients Enrolled
1 Trials studying Acanthamoeba Keratitis
49 Patients Enrolled for Acanthamoeba Keratitis
Federal University of São PauloOTHER
459 Previous Clinical Trials
102,831 Total Patients Enrolled
1 Trials studying Acanthamoeba Keratitis
232 Patients Enrolled for Acanthamoeba Keratitis
Thomas M. LietmanLead Sponsor
3 Previous Clinical Trials
1,042 Total Patients Enrolled

Media Library

Chlorhexidine Gluconate (Antiseptic) Clinical Trial Eligibility Overview. Trial Name: NCT05110001 — Phase 3
Acanthamoeba Keratitis Research Study Groups: Cross-Linking with rose Bengal (RB-PDT), Standard Therapy
Acanthamoeba Keratitis Clinical Trial 2023: Chlorhexidine Gluconate Highlights & Side Effects. Trial Name: NCT05110001 — Phase 3
Chlorhexidine Gluconate (Antiseptic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05110001 — Phase 3
Acanthamoeba Keratitis Patient Testimony for trial: Trial Name: NCT05110001 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Federal Drug Administration signed off on Rose Bengal?

"There is some efficacy data and multiple safety rounds supporting Phase 3 trials, which gives Rose Bengal a score of 3 for safety."

Answered by AI

What are some past examples of research using Rose Bengal?

"There are a total of 49 ongoing clinical trials researching Rose Bengal. Of these, 16 have reached Phase 3. The majority of these live studies for Rose Bengal are based in Redwood City, California; however, there are 586 locations running these sorts of investigations worldwide."

Answered by AI

How many individuals are included in the testing for this new medication?

"This trial is no longer recruiting patients. The listing for this particular study was first posted on June 1st, 2022 and the most recent update was on May 31st, 2022. 20 other trials are currently looking for patients with acanthamoeba keratitis while 49 studies are searching for individuals to participate who have been diagnosed with Rose Bengal."

Answered by AI

What is Rose Bengal's typical application?

"Rose Bengal is a medication with multiple functions. It can be used to treat community acquired pneumonia, wound infections, and topical antisepsis."

Answered by AI

To your knowledge, is this the inaugural clinical trial of its type?

"As of now, there are 49 ongoing medical trials that use Rose Bengal as part of the treatment. These studies are taking place in 260 cities and 48 nations. The first time this compound was used in a trial was back in 2009. 78 individuals participated in the Phase 1 study which Provectus Biopharmaceuticals, Inc. sponsored. In total, since 2009, 18735 separate trials have been completed that utilize rose bengal in some capacity."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Stanford University
Federal University of São Paulo
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I’ve tried other topicals. No results. I’m retired w lots of time.
PatientReceived 1 prior treatment
~134 spots leftby Apr 2025