Trial · NCT01357616
Fixed Combination Brinzolamide 1%/Timolol 0.5% Versus Brinzolamide 1% + Timolol 0.5% in Open-Angle Glaucoma or Ocular Hypertension
NCT01357616, Phase 3, Completed, Alcon Research; results first posted 2014-03-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Fixed Combination Brinzolamide 1%/Timolol 0.5% Versus Brinzolamide 1% + Timolol 0.5% in Open-Angle Glaucoma or Ocular Hypertension. Trials, record NCT01357616. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01357616
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fixed Combination Brinzolamide 1%/Timolol 0.5% Versus Brinzolamide 1% + Timolol 0.5% in Open-Angle Glaucoma or Ocular Hypertension
- NCT number
- NCT01357616
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 328 participants, actual
- Lead sponsor
- Alcon Research
- Conditions
- Open-Angle Glaucoma, Ocular Hypertension
- Interventions
- Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension, Brinzolamide 1% ophthalmic suspension, Timolol 0.5% ophthalmic solution
- First posted
- 2011-05-20
- Last updated
- 2014-04-10
- Results first posted
- 2014-03-13
Source ClinicalTrials.gov
Registered outcomes4
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 Week 8 | Baseline, Week 8 | Mean diurnal IOP change from baseline at Week 8 (ie, the subject IOP change from baseline averaged over the 9 AM, 11AM and 5 PM time points at Week 8) was measured by Goldmann applanation tonometry. 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 (fluid pressure inside the eye) can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater improvement.. |
| Secondary | Mean IOP Change From Baseline at 9 AM | Baseline, Up to Week 8 | Mean IOP change from baseline at 9 AM was measured by Goldmann applanation tonometry. 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 (fluid pressure inside the eye) can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater improvement. |
| Secondary | Mean IOP Change From Baseline at 11 AM | Baseline, Up to Week 8 | Mean IOP change from baseline at 11 AM was measured by Goldmann applanation tonometry. 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 (fluid pressure inside the eye) can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater improvement. |
| Secondary | Mean IOP Change From Baseline (5 PM) at Week 8 | Baseline, Week 8 | Mean IOP change from baseline (5 PM) at Week 8 was measured by Goldmann applanation tonometry. 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 (fluid pressure inside the eye) can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater improvement. |
Source ClinicalTrials.gov
Outcomes4
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 Week 8 | Baseline, Week 8 | This reporting group includes all subjects who received study medication, satisfied pre-randomization inclusion/exclusion criteria and completed at least 1 scheduled on-therapy study visit. | millimeters mercury (mmHg) | LEAST_SQUARES_MEAN |
| SECONDARY | Mean IOP Change From Baseline at 9 AM | Baseline, Up to Week 8 | This reporting group includes all subjects who received study medication, satisfied pre-randomization inclusion/exclusion criteria and completed at least 1 scheduled on-therapy study visit. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Mean IOP Change From Baseline at 11 AM | Baseline, Up to Week 8 | This reporting group includes all subjects who received study medication, satisfied pre-randomization inclusion/exclusion criteria and completed at least 1 scheduled on-therapy study visit. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Mean IOP Change From Baseline (5 PM) at Week 8 | Baseline, Week 8 | This reporting group includes all subjects who received study medication, satisfied pre-randomization inclusion/exclusion criteria and completed at least 1 scheduled on-therapy study visit. | mmHg | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group16
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 Week 8 | AZARGA | -6.84 | Standard Deviation 3.557 | millimeters mercury (mmHg) | |
| Mean Diurnal IOP Change From Baseline at Week 8 | AZOPT + Timolol | -6.00 | Standard Deviation 2.934 | millimeters mercury (mmHg) | |
| Mean IOP Change From Baseline at 9 AM | AZARGA | Change from baseline at Week 2 | -6.9 | Standard Deviation 3.62 | mmHg |
| Mean IOP Change From Baseline at 9 AM | AZOPT + Timolol | Change from baseline at Week 2 | -6.5 | Standard Deviation 3.43 | mmHg |
| Mean IOP Change From Baseline at 9 AM | AZARGA | Change from baseline at Week 4 | -7.3 | Standard Deviation 3.42 | mmHg |
| Mean IOP Change From Baseline at 9 AM | AZOPT + Timolol | Change from baseline at Week 4 | -6.4 | Standard Deviation 3.11 | mmHg |
| Mean IOP Change From Baseline at 9 AM | AZARGA | Change from baseline at Week 8 | -6.7 | Standard Deviation 3.97 | mmHg |
| Mean IOP Change From Baseline at 9 AM | AZOPT + Timolol | Change from baseline at Week 8 | -6.2 | Standard Deviation 3.30 | mmHg |
| Mean IOP Change From Baseline at 11 AM | AZARGA | Change from baseline at Week 2 | -7.5 | Standard Deviation 3.19 | mmHg |
| Mean IOP Change From Baseline at 11 AM | AZOPT + Timolol | Change from baseline at Week 2 | -6.8 | Standard Deviation 3.07 | mmHg |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AZARGA | 166 | |
| Overall Study | STARTED | AZOPT + TIMOLOL | 162 | |
| Overall Study | COMPLETED | AZARGA | 156 | |
| Overall Study | COMPLETED | AZOPT + TIMOLOL | 153 | |
| Overall Study | NOT COMPLETED | AZARGA | 10 | |
| Overall Study | NOT COMPLETED | AZOPT + TIMOLOL | 9 |
Source ClinicalTrials.gov
Adverse events4
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 |
|---|---|---|---|---|---|---|
| other | Heart rate decreased | Investigations | AZARGA (Test Group) | 14 | 165 | |
| other | Heart rate decreased | Investigations | AZOPT + TIMOLOL (Control Group) | 10 | 162 | |
| serious | Benign neoplasm of thymus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | AZARGA (Test Group) | 1 | 165 | 1 |
| serious | Benign neoplasm of thymus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | AZOPT + TIMOLOL (Control Group) | 0 | 162 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AZARGA (Test Group) | ||
| Total, all-cause mortality | AZOPT + TIMOLOL (Control Group) | ||
| Total, other adverse events | AZARGA (Test Group) | 14 | 165 |
| Total, other adverse events | AZOPT + TIMOLOL (Control Group) | 10 | 162 |
| Total, serious adverse events | AZARGA (Test Group) | 1 | 165 |
| Total, serious adverse events | AZOPT + TIMOLOL (Control Group) | 0 | 162 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|
| AZARGA (Test Group) vs AZOPT + TIMOLOL (Control Group): 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/NCT01357616
GET https://conductscience.org/api/trials/v1/NCT01357616/registered