Comparison · NCT01309204-sae
Brinz/Brim vs Brinz+Brim: 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. Brinz/Brim vs Brinz+Brim: serious adverse events. Trial comparisons, record NCT01309204-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01309204-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 | 0.0243 | 0.0136 | 0.043 | wilson | |
| Risk in group 2 | 0.0183 | 0.00933 | 0.0358 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00599 | -0.0145 | 0.0268 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.33 | 0.539 | 3.27 | log | |
| Odds ratio, group 1 over group 2 | 1.33 | 0.532 | 3.35 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Brinz/Brim than on Brinz+Brim | 167 | 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 | Brinz/Brim | Vehicle, 1 drop instilled in each eye, followed by Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months. | 11 | 452 | EG000 |
| Group 2 | Brinz+Brim | Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye, followed by Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months. | 8 | 436 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse events (AE) were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject that was administered a study medication, regardless of causal relationship with the medication.
Source ClinicalTrials.gov
Trial
- Title
- Brinzolamide/Brimonidine Twice a Day (BID) Fixed Combination (FC) vs Brinzolamide BID Plus Brimonidine BID in Patients With Open Angle Glaucoma or Ocular Hypertension
- NCT number
- NCT01309204
- Phases
- PHASE3
- Conditions
- Open-Angle Glaucoma, Ocular Hypertension
- Interventions
- Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension, Vehicle, Brinzolamide 1% ophthalmic suspension, Brimonidine tartrate 0.2% ophthalmic solution
- Lead sponsor
- Alcon Research
- Results first posted
- 2014-04-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01309204?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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