Comparison · NCT00645671-sae
Loteprednol Etabonate vs Vehicle: 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. Loteprednol Etabonate vs Vehicle: serious adverse events. Trial comparisons, record NCT00645671-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00645671-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 | 0.0149 | 0.00509 | 0.043 | wilson | |
| Risk in group 2 | 0.0101 | 0.00276 | 0.0359 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00488 | -0.0228 | 0.0338 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.49 | 0.251 | 8.79 | log | |
| Odds ratio, group 1 over group 2 | 1.49 | 0.247 | 9.03 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Loteprednol Etabonate than on Vehicle | 205 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: vehicle.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Loteprednol Etabonate | Loteprednol etabonate 0.5% ophthalmic ointment | 3 | 201 | EG000 |
| Group 2 | Vehicle | Vehicle of loteprednol etabonate ointment | 2 | 199 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
The LE treatment group had a mean exposure of 13.2 days (+/-3.06), the vehicle treatment group mean exposure was 9.2 days (+/-5.10). Mean days of exposure was < 14 days due to the use of rescue medication, especially in the vehicle group.
Source ClinicalTrials.gov
Trial
- Title
- Loteprednol Etabonate Ophthalmic Ointment vs. Vehicle in the Treatment of Inflammation Following Cataract Surgery
- NCT number
- NCT00645671
- Phases
- PHASE3
- Conditions
- Ocular Inflammation
- Interventions
- 0.5% Loteprednol Etabonate Ophthalmic Ointment, Vehicle of Loteprednol Etabonate Ophthalmic Ointment
- Lead sponsor
- Bausch & Lomb Incorporated
- Results first posted
- 2010-09-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00645671?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/NCT00645671-sae