A Phase 3 interventional study of Moxifloxacin Ophthalmic and Chlorhexidine Gluconate in Acanthamoeba Keratitis and Fungal Keratitis, sponsored by University of California, San Francisco. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by University of California, San Francisco · Phase 3, Interventional, and Treatment
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Rose Bengal Electromagnetic Activation with Green light for Infection Reduction (REAGIR ) is an international, randomized, doubled masked, clinical trial. 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 either smear or culture positive fungal or acanthamoeba keratitis or smear and culture negative corneal ulcers and moderate to severe vision loss, defined as Snellen visual acuity of 20/40 or worse, will be eligible for inclusion. Those who agree to participate will be randomized to one of two treatment groups:
Group 4, Sham RB-PDT: topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus sham RB-PDT
Group 5, RB-PDT: topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus RB-PDT.
University of California, San Francisco is the lead sponsor of 2,171 studies on the registry; 370 are open to participants now.
Of its 268 completed or terminated interventional studies of FDA-regulated products, 203 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: Moxifloxacin Ophthalmic · Drug: Chlorhexidine Gluconate · Drug: Natamycin · Other: Placebo
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
Drug: Moxifloxacin Ophthalmic · Drug: Chlorhexidine Gluconate · Drug: Natamycin · Drug: Rose Bengal
Topical moxifloxacin 0.5% is a fluoroquinolone antibiotic that is used to treat bacterial infections. This is a standard therapy for bacterial keratitis.
Topical chlorhexidine gluconate 0.02% is an antiseptic agent, with both antibacterial and antifungal properties. This is a standard therapy for Acanthamoeba keratitis.
Natamycin 5% is an antifungal agent used to treat fungi that cause keratitis. This is a standard therapy for fungal keratitis.
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.
Also known as: Corneal Cross Linking with rose Bengal
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.
Best Spectacle-Corrected Visual Acuity
Best Spectacle-Corrected Visual Acuity
Time frame: 6 Months
Best Spectacle-Corrected Visual Acuity
Best Spectacle-Corrected Visual Acuity
Time frame: 3 Weeks, 3 Months, 12 Months
Scar Size
Geometric Mean
Time frame: 3 Weeks, 3 Months, 6 Months 12 Months
| Milestone | Standard Therapy | Cross-Linking With Rose Bengal (RB-PDT) |
|---|---|---|
| Started | 165 | 165 |
| Completed | 149 | 148 |
| Not completed | 16 | 17 |
Best Spectacle-Corrected Visual Acuity
| logMAR | Standard Therapy | Cross-Linking With Rose Bengal (RB-PDT) |
|---|---|---|
| Best Spectacle-Corrected Visual Acuity | 0.614 ± 0.658 | 0.666 ± 0.675 |
Best Spectacle-Corrected Visual Acuity
| logMAR | Standard Therapy | Cross-Linking With Rose Bengal (RB-PDT) |
|---|---|---|
| 3-week | 0.821 ± 0.630 | 0.855 ± 0.617 |
| 3-month | 0.700 ± 0.661 | 0.772 ± 0.673 |
| 12- month | 0.531 ± 0.662 | 0.611 ± 0.669 |
Geometric Mean
| mm | Standard Therapy | Cross-Linking With Rose Bengal (RB-PDT) |
|---|---|---|
| 3-weeks | 3.84 ± 1.64 | 3.37 ± 1.35 |
| 3-months | 3.99 ± 1.61 | 3.71 ± 1.52 |
| 6-months | 3.96 ± 1.63 | 3.73 ± 1.53 |
| 12-months | 3.65 ± 1.62 | 3.64 ± 1.43 |
Collected over 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard Therapy | 1/165 (0.6%) | 31/165 (18.8%) | 17/165 (10.3%) |
| Cross-Linking With Rose Bengal (RB-PDT) | 0/165 (0%) | 36/165 (21.8%) | 25/165 (15.2%) |
| Event | Standard Therapy | Cross-Linking With Rose Bengal (RB-PDT) |
|---|---|---|
| Therapeutic Penetrating KeratoplastyEye disorders | 20/165 | 29/165 |
| Therapeutic Penetrating Keratoplasty and Corneal PerforationEye disorders | 9/165 | 4/165 |
| Corneal perforationEye disorders | 2/165 | 2/165 |
| Non-elective surgery, hospitalization, or loss of functionInjury, poisoning and procedural complications | 0/165 | 1/165 |
| Event | Standard Therapy | Cross-Linking With Rose Bengal (RB-PDT) |
|---|---|---|
| Increase in the longest diameter of infiltrate (>50% increase from baseline and >1mm)Eye disorders | 10/165 | 14/165 |
| Increase in hypopyon (increase >2mm)Eye disorders | 6/165 | 7/165 |
| Progressive corneal thinning, < 50% of enrollment thicknessEye disorders | 1/165 | 3/165 |
| OtherEye disorders | 0/165 | 1/165 |
| Age, Continuous(years) | Standard Therapy | Cross-Linking With Rose Bengal (RB-PDT) | Total |
|---|---|---|---|
| Mean | 50 ± 12 | 50 ± 13 | 50 ± 13 |
| Sex: Female, Male(Participants) | Standard Therapy | Cross-Linking With Rose Bengal (RB-PDT) | Total |
|---|---|---|---|
| Female | 58 | 59 | 117 |
| Male | 107 | 106 | 213 |
| Ethnicity (NIH/OMB)(Participants) | Standard Therapy | Cross-Linking With Rose Bengal (RB-PDT) | Total |
|---|---|---|---|
| Hispanic or Latino | 7 | 6 | 13 |
| Not Hispanic or Latino | 148 | 150 | 298 |
| Unknown or Not Reported | 10 | 9 | 19 |
| Race (NIH/OMB)(Participants) | Standard Therapy | Cross-Linking With Rose Bengal (RB-PDT) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 3 | 3 |
| Asian | 151 | 147 | 298 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 1 | 3 |
| White | 2 | 1 | 3 |
| More than one race | 2 | 4 | 6 |
| Unknown or Not Reported | 8 | 9 | 17 |
| Visual Acuity (logMAR BSCVA)(logMar) | Standard Therapy | Cross-Linking With Rose Bengal (RB-PDT) | Total |
|---|---|---|---|
| Mean | 1.1 ± 0.50 | 1.2 ± 0.51 | 1.1 ± 0.50 |
| Central Corneal Thickness (μm)(μm) | Standard Therapy | Cross-Linking With Rose Bengal (RB-PDT) | Total |
|---|---|---|---|
| Mean | 630 ± 130 | 650 ± 130 | 640 ± 130 |
| Hypopyon(Participants) | Standard Therapy | Cross-Linking With Rose Bengal (RB-PDT) | Total |
|---|---|---|---|
| None | 99 | 87 | 186 |
| < 0.5 mm | 14 | 17 | 31 |
| Other | 52 | 61 | 113 |
| Infiltrate/Scar Size (mm)(mm) | Standard Therapy | Cross-Linking With Rose Bengal (RB-PDT) | Total |
|---|---|---|---|
| Mean | 3.7 ± 1.4 | 3.8 ± 1.5 | 3.8 ± 1.4 |
9 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Aug 2022 to primary completion in Dec 2024, 28 months.
Results were first posted in Jan 2026, 1 year 1 month after primary completion.
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Studies of the drug tested here: Rose Bengal
Acanthamoeba Keratitis
University of California, San Francisco →