Comparison · NCT02688556-sae
OTX-101 0.09% 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. OTX-101 0.09% vs Vehicle: serious adverse events. Trial comparisons, record NCT02688556-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02688556-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 | 0.0161 | 0.00741 | 0.0347 | wilson | |
| Risk in group 2 | 0.00538 | 0.00148 | 0.0194 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0108 | -0.00575 | 0.0298 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3 | 0.609 | 14.8 | log | |
| Odds ratio, group 1 over group 2 | 3.03 | 0.608 | 15.1 | log | |
| Number needed to harm, for one more participant with a serious adverse event on OTX-101 0.09% than on Vehicle | 93 | 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 | OTX-101 0.09% | 0.09% cyclosporine nanomicellar ophthalmic solution.~A total of 744 subjects were included in the Safety population, with 372 subjects in the OTX-101 0.09% group and 372 subjects in the Vehicle group. The only difference between the ITT and the Safety populations is that Subject 14-003 was analyzed in the Safety population according to the treatment received, which was OTX-101 0.09% | 6 | 372 | EG000 |
| Group 2 | Vehicle | vehicle of OTX-101~A total of 744 subjects were included in the Safety population, with 372 subjects in the OTX-101 0.09% group and 372 subjects in the Vehicle group. The only difference between the ITT and the Safety populations is that Subject 14-003 was analyzed in the Safety population according to the treatment received, which was OTX-101 0.09% | 2 | 372 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 12 weeks
Source ClinicalTrials.gov
Trial
- Title
- Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
- NCT number
- NCT02688556
- Phases
- PHASE3
- Conditions
- Keratoconjunctivitis Sicca
- Interventions
- cyclosporine, vehicle of OTX-101
- Lead sponsor
- Sun Pharmaceutical Industries Limited
- Results first posted
- 2019-04-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02688556?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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