Comparison · NCT05110001-sae
Standard Therapy vs Cross-Linking With Rose Bengal (RB-PDT): serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Download JSON
Cite this record
ConductScience Library. Standard Therapy vs Cross-Linking With Rose Bengal (RB-PDT): serious adverse events. Trial comparisons, record NCT05110001-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05110001-sae
On this page
Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.188 | 0.136 | 0.254 | wilson | |
| Risk in group 2 | 0.218 | 0.162 | 0.287 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0303 | -0.117 | 0.0567 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.861 | 0.561 | 1.32 | log | |
| Odds ratio, group 1 over group 2 | 0.829 | 0.484 | 1.42 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Standard Therapy than on Cross-Linking With Rose Bengal (RB-PDT) | 33 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Standard Therapy | 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~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.~Chlorhexidine Gluconate: Topical chlorhexidine gluconate 0.02% is an antiseptic agent, with both antibacterial and antifungal properties. This is a standard therapy for Acanthamoeba keratitis.~Natamycin: Natamycin 5% is an antifungal agent used to treat fungi that cause keratitis. This is a standard therapy for fungal keratitis.~Placebo: 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. | 31 | 165 | EG000 |
| Group 2 | Cross-Linking With Rose Bengal (RB-PDT) | 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~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.~Chlorhexidine Gluconate: Topical chlorhexidine gluconate 0.02% is an antiseptic agent, with both antibacterial and antifungal properties. This is a standard therapy for Acanthamoeba keratitis.~Natamycin: Natamycin 5% is an antifungal agent used to treat fungi that cause keratitis. This is a standard therapy for fungal keratitis.~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 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. | 36 | 165 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 12 months
Source ClinicalTrials.gov
Trial
- Title
- Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction
- NCT number
- NCT05110001
- Phases
- PHASE3
- Conditions
- Acanthamoeba Keratitis, Fungal Keratitis
- Interventions
- Moxifloxacin Ophthalmic, Chlorhexidine Gluconate, Natamycin, Rose Bengal, Placebo
- Lead sponsor
- University of California, San Francisco
- Results first posted
- 2026-01-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05110001?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT05110001-sae