Comparison · NCT01602068-sae
Dexamethasone Phosphate Ophthalmic vs 100 mM Sodium Citrate Buffer: 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. Dexamethasone Phosphate Ophthalmic vs 100 mM Sodium Citrate Buffer: serious adverse events. Trial comparisons, record NCT01602068-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01602068-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 | 0 | 0.143 | wilson | |
| Risk in group 2 | 0.136 | 0.0475 | 0.333 | wilson | |
| Risk difference, group 1 minus group 2 | -0.136 | -0.333 | 0.0321 | 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 treat, for one fewer participant with a serious adverse event on Dexamethasone Phosphate Ophthalmic than on 100 mM Sodium Citrate Buffer | 7.33 | 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 | Dexamethasone Phosphate Ophthalmic | Dexamethasone Phosphate Ophthalmic: (40 mg/mL) solution delivered by transcleral iontophoresis consisting of 4.0 mA-min at 1.5 mA on Day -1 (the day before cataract surgery) | 0 | 23 | EG000 |
| Group 2 | 100 mM Sodium Citrate Buffer | Placebo (100 mM sodium citrate buffer solution) delivered by transcleral iontophoresis consisting of 4.0 mA-min at 1.5 mA on Day -1 (the day before cataract surgery) | 3 | 22 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- AEs were collected from the point that the ICF was signed. All AEs until the last day of the study, through resolution, stabilization, or at least 30 days after treatment, whichever occurs first.
Source ClinicalTrials.gov
Trial
- Title
- Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Delivery Prior to Implantation of a Posterior Chamber IOL
- NCT number
- NCT01602068
- Phases
- PHASE2
- Conditions
- Cataract
- Interventions
- Dexamethasone Phosphate Ophthalmic, 100 mM Sodium Citrate Buffer
- Lead sponsor
- Eyegate Pharmaceuticals, Inc.
- Results first posted
- 2018-05-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01602068?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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