Comparison · NCT03691662-sae
DE-117 Ophthalmic Solution vs Timolol Maleate Ophthalmic Solution 0.5%: 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 Timolol Maleate Ophthalmic Solution 0.5%: serious adverse events. Trial comparisons, record NCT03691662-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03691662-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 | 0.0343 | 0.0167 | 0.0691 | wilson | |
| Risk in group 2 | 0.00488 | 0.000862 | 0.0271 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0294 | 0.00108 | 0.0645 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 7.03 | 0.873 | 56.7 | log | |
| Odds ratio, group 1 over group 2 | 7.25 | 0.884 | 59.5 | log | |
| Number needed to harm, for one more participant with a serious adverse event on DE-117 Ophthalmic Solution than on Timolol Maleate Ophthalmic Solution 0.5% | 34 | 15.5 | 922 | from the risk difference interval |
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 | Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months~DE-117 Ophthalmic Solution: Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months | 7 | 204 | EG000 |
| Group 2 | Timolol Maleate Ophthalmic Solution 0.5% | Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months~Timolol Maleate Ophthalmic Solution 0.5%: Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months | 1 | 205 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3.
Source ClinicalTrials.gov
Trial
- Title
A Phase III Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 4 Study
- NCT number
- NCT03691662
- Phases
- PHASE3
- Conditions
- Glaucoma and Ocular Hypertension
- Interventions
- DE-117 Ophthalmic Solution, Timolol Maleate Ophthalmic Solution 0.5%
- Lead sponsor
- Santen Inc.
- Results first posted
- 2023-08-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03691662?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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