Comparison · NCT02981446-sae
DE-117 Ophthalmic Solution vs Latanoprost Ophthalmic Solution 0.005%: 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. DE-117 Ophthalmic Solution vs Latanoprost Ophthalmic Solution 0.005%: serious adverse events. Trial comparisons, record NCT02981446-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02981446-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 | 0.0108 | 0.00297 | 0.0386 | wilson | |
| Risk in group 2 | 0.0108 | 0.00297 | 0.0386 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.0288 | 0.0288 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.142 | 7.02 | log | |
| Odds ratio, group 1 over group 2 | 1 | 0.139 | 7.18 | log | |
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
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 | DE-117 Ophthalmic Solution | DE-117: DE-117 ophthalmic solution will be taken one drop, once daily for 3 months in both eyes. | 2 | 185 | EG000 |
| Group 2 | Latanoprost Ophthalmic Solution 0.005% | Latanoprost ophthalmic solution: Latanoprost ophthalmic solution will be taken one drop, once daily for 3 months in both eyes. | 2 | 185 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization.
Source ClinicalTrials.gov
Trial
- Title
- A Phase III Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Compared With Latanoprost Ophthalmic Solution in Subjects With OAG or OHT
- NCT number
- NCT02981446
- Phases
- PHASE3
- Conditions
- Open Angle Glaucoma or Ocular Hypertension
- Interventions
- DE-117, Latanoprost ophthalmic solution
- Lead sponsor
- Santen Pharmaceutical Co., Ltd.
- Results first posted
- 2024-03-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02981446?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
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