Comparison · NCT02132312-b5c4debd
OMS302 vs Phenylephrine HCl: Safety as Measured by Treatment-emergent Adverse Events, the Number of Affected Patients/at Risk (%) and the Number of 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. OMS302 vs Phenylephrine HCl: Safety as Measured by Treatment-emergent Adverse Events, the Number of Affected Patients/at Risk (%) and the Number of Events. Trial comparisons, record NCT02132312-b5c4debd. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02132312-b5c4debd
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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 | 0.469 | 0.309 | 0.636 | wilson | |
| Risk in group 2 | 0.45 | 0.307 | 0.602 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0187 | -0.202 | 0.238 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.04 | 0.63 | 1.72 | log | |
| Odds ratio, group 1 over group 2 | 1.08 | 0.424 | 2.74 | log | |
| Number needed to treat, for one more participant with the outcome on OMS302 than on Phenylephrine HCl | 53.3 | 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 | OMS302 | OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution~OMS302 | 15 | 32 | OG000 |
| Group 2 | Phenylephrine HCl | Phenylephrine diluted in balanced salt solution (BSS) and administered as irrigation solution~Phenylephrine HCl | 18 | 40 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Safety as Measured by Treatment-emergent Adverse Events, the Number of Affected Patients/at Risk (%) and the Number of Events.
- Description
- Safety as assessed by the incidence of adverse events and serious adverse events up until the last visit at Day 90.
- Time frame
- 90 days
- Population
78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. Out of the 72 participants, one participant was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.
Source ClinicalTrials.gov
Trial
- Title
- A Randomized Study in Children Ages Birth Through Three Years Undergoing Unilateral Cataract Extraction With or Without Lens Replacement
- NCT number
- NCT02132312
- Phases
- PHASE3
- Conditions
- Unilateral Cataract Extraction, Congenital Cataract
- Interventions
- OMS302, Phenylephrine HCl
- Lead sponsor
- Omeros Corporation
- Results first posted
- 2021-07-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02132312?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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