Comparison · NCT02216071-a13ca80b
Ciprodex®, RLD vs EXL CDOS: Number of Participants With Microbiological Cure (MC)
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. Ciprodex®, RLD vs EXL CDOS: Number of Participants With Microbiological Cure (MC). Trial comparisons, record NCT02216071-a13ca80b. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02216071-a13ca80b
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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 | 0.719 | 0.645 | 0.783 | wilson | |
| Risk in group 2 | 0.785 | 0.713 | 0.844 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0665 | -0.161 | 0.0303 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.915 | 0.805 | 1.04 | log | |
| Odds ratio, group 1 over group 2 | 0.699 | 0.415 | 1.18 | log | |
| Number needed to treat, for one fewer participant with the outcome on Ciprodex®, RLD than on EXL CDOS | 15 | 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 | Ciprodex®, RLD | Ciprodex®, Otic Suspension, Twice daily for 7 days~Ciprodex®: Treatment of acute otitis externa (AOE) when administered twice daily for 7 days | 115 | 160 | OG000 |
| Group 2 | EXL CDOS | EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension, Otic Suspension, Twice daily for 7 days~EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension: Treatment of acute otitis externa (AOE) when administered twice daily for 7 days | 117 | 149 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Microbiological Cure (MC)
- Description
The secondary efficacy endpoint was the microbiological cure of AOE, defined as the proportion of subjects with microbiological cure at the TOC Visit. Subjects with AOE in both ears were considered to have achieved microbiological cure if microbiological cure was achieved in both ears.
- Time frame
- 7 days after the completion of therapy; at Day 15 (+/- 1 day)
- Population
- The number of participants analyzed represents Bacteria-Positive cohort of subjects
Source ClinicalTrials.gov
Trial
- Title
- Comparative Efficacy and Safety of Ciprofloxacin 0.3% and Dexamethasone 0.1% in Acute Otitis Externa
- NCT number
- NCT02216071
- Phases
- PHASE3
- Conditions
- Acute Otitis Externa
- Interventions
- Ciprodex®, EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension
- Lead sponsor
- Exela Pharma Sciences, LLC.
- Results first posted
- 2021-05-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02216071?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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