Trial · NCT01309204
Brinzolamide/Brimonidine Twice a Day (BID) Fixed Combination (FC) vs Brinzolamide BID Plus Brimonidine BID in Patients With Open Angle Glaucoma or Ocular Hypertension
NCT01309204, Phase 3, Completed, Alcon Research; results first posted 2014-04-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Brinzolamide/Brimonidine Twice a Day (BID) Fixed Combination (FC) vs Brinzolamide BID Plus Brimonidine BID in Patients With Open Angle Glaucoma or Ocular Hypertension. Trials, record NCT01309204. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01309204
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- 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
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,184 participants, actual
- Lead sponsor
- Alcon Research
- 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
- First posted
- 2011-03-07
- Last updated
- 2014-04-07
- Other registries' IDs
- eudract:2010-024513-31
- Results first posted
- 2014-04-07
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Diurnal IOP Change From Baseline at Month 3 | Baseline (Day 1), Month 3 | Mean Diurnal IOP Change from Baseline at Month 3 (ie, the subject IOP change from baseline averaged over the 9 AM and + 2 h time points at Month 3) was measured by Goldmann applanation tonometry. The study drug was instilled approximately 15 minutes after conducting the 9AM IOP measurement. One eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Diurnal IOP Change From Baseline at Month 3 | Baseline (Day 1), Month 3 | Per Protocol (PP): All subjects who received study medication, satisfied prerandomization inclusion/exclusion criteria, and completed at least 1 scheduled on-therapy study visit. In addition, individual subject visits and data points that did not satisfy the protocol criteria may have been excluded. | millimeters of mercury (mmHg) | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Diurnal IOP Change From Baseline at Month 3 | Brinz/Brim | -8.5 | Standard Error 0.16 | millimeters of mercury (mmHg) | |
| Mean Diurnal IOP Change From Baseline at Month 3 | Brinz+Brim | -8.3 | Standard Error 0.16 | millimeters of mercury (mmHg) |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Brinz/Brim | 452 | |
| Overall Study | STARTED | Brinz+Brim | 436 | |
| Overall Study | COMPLETED | Brinz/Brim | 385 | |
| Overall Study | COMPLETED | Brinz+Brim | 361 | |
| Overall Study | NOT COMPLETED | Brinz/Brim | 67 | |
| Overall Study | NOT COMPLETED | Brinz+Brim | 75 |
Source ClinicalTrials.gov
Adverse events40
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Corneal erosion | Eye disorders | Brinz/Brim | 2 | 452 | |
| serious | Corneal erosion | Eye disorders | Brinz+Brim | 0 | 436 | |
| serious | Aortic valve incompetence | Cardiac disorders | Brinz/Brim | 1 | 452 | |
| serious | Aortic valve incompetence | Cardiac disorders | Brinz+Brim | 0 | 436 | |
| serious | Arthroscopy | Investigations | Brinz/Brim | 1 | 452 | |
| serious | Arthroscopy | Investigations | Brinz+Brim | 0 | 436 | |
| serious | Finger amputation | Surgical and medical procedures | Brinz/Brim | 1 | 452 | |
| serious | Finger amputation | Surgical and medical procedures | Brinz+Brim | 0 | 436 | |
| serious | Headache | Nervous system disorders | Brinz/Brim | 1 | 452 | |
| serious | Headache | Nervous system disorders | Brinz+Brim | 0 | 436 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Brinz/Brim | ||
| Total, all-cause mortality | Brinz+Brim | ||
| Total, other adverse events | Brinz/Brim | 0 | 452 |
| Total, other adverse events | Brinz+Brim | 0 | 436 |
| Total, serious adverse events | Brinz/Brim | 11 | 452 |
| Total, serious adverse events | Brinz+Brim | 8 | 436 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25430900 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Brinz/Brim vs Brinz+Brim: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01309204
GET https://conductscience.org/api/trials/v1/NCT01309204/events?page=2