Comparison · NCT00347932-sae
ISV-403 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. ISV-403 vs Vehicle: serious adverse events. Trial comparisons, record NCT00347932-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00347932-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 | 0.00226 | 0.000399 | 0.0127 | wilson | |
| Risk in group 2 | 0.00231 | 0.000409 | 0.013 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0000524 | -0.0109 | 0.0106 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.977 | 0.0613 | 15.6 | log | |
| Odds ratio, group 1 over group 2 | 0.977 | 0.0609 | 15.7 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on ISV-403 than on Vehicle | 19,100 | 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 | ISV-403 | Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days. | 1 | 442 | EG000 |
| Group 2 | Vehicle | Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days. | 1 | 432 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 8 days
Source ClinicalTrials.gov
Trial
- Title
- A Study to Determine if 0.6% ISV-403 is Safe and Effective in the Treatment of Bacterial Conjunctivitis.
- NCT number
- NCT00347932
- Phases
- PHASE3
- Conditions
- Acute Bacterial Conjunctivitis
- Interventions
- ISV-403, Vehicle
- Lead sponsor
- Bausch & Lomb Incorporated
- Results first posted
- 2009-08-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00347932?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/NCT00347932-sae