Comparison · NCT03739528-sae
Levofloxacin + Dexamethasone Followed by Dexamethasone vs Tobramycin + Dexamethasone: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Levofloxacin + Dexamethasone Followed by Dexamethasone vs Tobramycin + Dexamethasone: serious adverse events. Trial comparisons, record NCT03739528-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03739528-sae
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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 | 0.0103 | 0.00402 | 0.0262 | wilson | |
| Risk in group 2 | 0.00515 | 0.00141 | 0.0186 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00515 | -0.00969 | 0.0215 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2 | 0.368 | 10.9 | log | |
| Odds ratio, group 1 over group 2 | 2.01 | 0.366 | 11 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Levofloxacin + Dexamethasone Followed by Dexamethasone than on Tobramycin + Dexamethasone | 194 | 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 | Levofloxacin + Dexamethasone Followed by Dexamethasone | Levofloxacin + dexamethasone ophthalmic solution containing levofloxacin hemihydrate 5.12 mg/ml, corresponding to levofloxacin 5 mg/ml, and dexamethasone sodium phosphate 1.32 mg/ml, corresponding to dexamethasone 1 mg/ml (L-DSP), followed by Dexamethasone 1 mg/ml ophthalmic suspension (Maxidex)~Dose and regimen: Levofloxacin + dexamethasone sodium phosphate eye drops for 7 days, 1 x 30 μl drop - 4 times a day, followed by dexamethasone eye drops (Maxidex) for an additional 7 days, 1 drop - 4 times a day. | 4 | 388 | EG000 |
| Group 2 | Tobramycin + Dexamethasone | Tobramycin 3 mg/ml + dexamethasone 1 mg/ml eye drops suspension (Tobradex)~Dose and regimen: 1 drop - 4 times a day for 14 days | 2 | 388 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From baseline to the end of the treatment, corresponding to 15 days
Source ClinicalTrials.gov
Trial
- Title
- Levo-Dexa vs. Tobra+Dexa for Prevention and Treatment of Inflammation and Prevention of Infection in Cataract Surgery
- NCT number
- NCT03739528
- Phases
- PHASE3
- Conditions
- Cataract
- Interventions
- Levofloxacin + dexamethasone followed by dexamethasone, Tobramycin + Dexamethasone
- Lead sponsor
- NTC srl
- Results first posted
- 2020-08-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03739528?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.
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