Comparison · NCT04685538-sae
Chloroprocaine 3% vs Tetracaine 0.5%: 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. Chloroprocaine 3% vs Tetracaine 0.5%: serious adverse events. Trial comparisons, record NCT04685538-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04685538-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 | 0 | 0.0225 | wilson | |
| Risk in group 2 | 0 | 0 | 0.022 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.022 | 0.0225 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
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 | Chloroprocaine 3% | All the eligible patients will be administrated by Chloroprocaine 3 % according to the randomization criteria.~Chloroprocaine 3%: Administration: three IMP drops instillation as follow:~* 1st Drop instillation, then wait for 5 minutes~* Eye Disinfection, then wait for 2 minutes~* 2nd Drop instillation, then wait for 1 minute~* 3rdDrop instillation, then wait for 1 minute~* Start of Surgery. | 0 | 167 | EG000 |
| Group 2 | Tetracaine 0.5% | All the eligible patients will be administrated by Tetracaine 0.5% according to the randomization criteria.~Tetracaine 0.5%: Administration: three IMP drops instillation as follow:~* 1st Drop instillation, then wait for 5 minutes~* Eye Disinfection, then wait for 2 minutes~* 2nd Drop instillation, then wait for 1 minute~* 3rdDrop instillation, then wait for 1 minute~* Start of Surgery. | 0 | 171 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were to be monitored throughout the course of the study Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day)) up to Visit 5 (Day 28 ± 3 days; approximately 129 days
Source ClinicalTrials.gov
Trial
- Title
- Chloroprocaine 3% Gel Eye Drop as Topical Anestheticsin Phacoemulsification.
- NCT number
- NCT04685538
- Phases
- PHASE3
- Conditions
- Cataract
- Interventions
- Chloroprocaine 3%, Tetracaine 0.5%
- Lead sponsor
- Sintetica SA
- Results first posted
- 2022-10-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04685538?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/NCT04685538-sae