Trial · NCT02512042
Bioequivalence Study With Clinical Endpoint Comparing Brinzolamide 1% Ophthalmic Suspension to Azopt® 1% Ophthalmic Suspension In the Treatment of Chronic Open Angle Glaucoma or Ocular Hypertension in Both Eyes
NCT02512042, Phase 3, Completed, Actavis Inc.; results first posted 2020-03-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Bioequivalence Study With Clinical Endpoint Comparing Brinzolamide 1% Ophthalmic Suspension to Azopt® 1% Ophthalmic Suspension In the Treatment of Chronic Open Angle Glaucoma or Ocular Hypertension in Both Eyes. Trials, record NCT02512042. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02512042
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Bioequivalence Study With Clinical Endpoint Comparing Brinzolamide 1% Ophthalmic Suspension to Azopt® 1% Ophthalmic Suspension In the Treatment of Chronic Open Angle Glaucoma or Ocular Hypertension in Both Eyes
- NCT number
- NCT02512042
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 973 participants, actual
- Lead sponsor
- Actavis Inc.
- Conditions
- Glaucoma
- Interventions
- Test-Brinzolamide 1% Ophthalmic suspension, Reference-Brinzolamide 1% Ophthalmic suspension
- First posted
- 2015-07-30
- Last updated
- 2020-03-02
- Results first posted
- 2020-03-02
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Difference in Intraocular Pressure (IOP) of Both Eyes Between the Two Treatment Groups at Four Time Points | Day 14 and 42 at 8AM and 10AM | The primary efficacy end point is the mean difference in intraocular pressure (IOP) of both eyes between the two treatment groups at four time points, i.e., at approximately 8:00 am (hour 0; before the morning drop) and 10:00 am (hour 2; after the morning drop) at the Day 14 (week 2) and Day 42 (week 6) visits |
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 Difference in Intraocular Pressure (IOP) of Both Eyes Between the Two Treatment Groups at Four Time Points | Day 14 and 42 at 8AM and 10AM | Participants in Per Protocol Population who met inclusion/exclusion criteria, instilled a pre-specified proportion of the scheduled doses for the specified duration of the study, who did not miss scheduled applications for more than 3 days, and completed evaluations at Day 14 and Day 42 within the visit window. | mmHg | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Difference in Intraocular Pressure (IOP) of Both Eyes Between the Two Treatment Groups at Four Time Points | Generic Brinzolamide Ophthalmic Suspension USP 1% | 8AM Visit Day 14 | 19.35 | Standard Deviation 2.860 | mmHg |
| Mean Difference in Intraocular Pressure (IOP) of Both Eyes Between the Two Treatment Groups at Four Time Points | Azopt® (Brinzolomide Ophthalmic Suspension USP 1%) | 8AM Visit Day 14 | 19.75 | Standard Deviation 2.874 | mmHg |
| Mean Difference in Intraocular Pressure (IOP) of Both Eyes Between the Two Treatment Groups at Four Time Points | Generic Brinzolamide Ophthalmic Suspension USP 1% | 8AM Visit Day 42 | 18.53 | Standard Deviation 2.894 | mmHg |
| Mean Difference in Intraocular Pressure (IOP) of Both Eyes Between the Two Treatment Groups at Four Time Points | Azopt® (Brinzolomide Ophthalmic Suspension USP 1%) | 8AM Visit Day 42 | 18.66 | Standard Deviation 2.851 | mmHg |
| Mean Difference in Intraocular Pressure (IOP) of Both Eyes Between the Two Treatment Groups at Four Time Points | Generic Brinzolamide Ophthalmic Suspension USP 1% | 10AM Visit Day 14 | 18.70 | Standard Deviation 2.805 | mmHg |
| Mean Difference in Intraocular Pressure (IOP) of Both Eyes Between the Two Treatment Groups at Four Time Points | Azopt® (Brinzolomide Ophthalmic Suspension USP 1%) | 10AM Visit Day 14 | 19.18 | Standard Deviation 2.710 | mmHg |
| Mean Difference in Intraocular Pressure (IOP) of Both Eyes Between the Two Treatment Groups at Four Time Points | Generic Brinzolamide Ophthalmic Suspension USP 1% | 10AM Visit Day 42 | 17.94 | Standard Deviation 2.734 | mmHg |
| Mean Difference in Intraocular Pressure (IOP) of Both Eyes Between the Two Treatment Groups at Four Time Points | Azopt® (Brinzolomide Ophthalmic Suspension USP 1%) | 10AM Visit Day 42 | 18.16 | Standard Deviation 2.824 | 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 | Generic Brinzolamide Ophthalmic Suspension USP 1% | 495 | |
| Overall Study | STARTED | Azopt® (Brinzolomide Ophthalmic Suspension USP 1%) | 478 | |
| Overall Study | COMPLETED | Generic Brinzolamide Ophthalmic Suspension USP 1% | 472 | |
| Overall Study | COMPLETED | Azopt® (Brinzolomide Ophthalmic Suspension USP 1%) | 453 | |
| Overall Study | NOT COMPLETED | Generic Brinzolamide Ophthalmic Suspension USP 1% | 23 | |
| Overall Study | NOT COMPLETED | Azopt® (Brinzolomide Ophthalmic Suspension USP 1%) | 25 |
Source ClinicalTrials.gov
Adverse events130
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 | Palpitations | Cardiac disorders | Generic Brinzolamide 1% Ophthalmic Suspension | 1 | 489 | 1 |
| other | Palpitations | Cardiac disorders | Azopt® 1% Ophthalmic Suspension | 0 | 475 | 0 |
| other | Sinus bradycardia | Cardiac disorders | Generic Brinzolamide 1% Ophthalmic Suspension | 1 | 489 | 1 |
| other | Sinus bradycardia | Cardiac disorders | Azopt® 1% Ophthalmic Suspension | 0 | 475 | 0 |
| other | Asthenopia | Eye disorders | Generic Brinzolamide 1% Ophthalmic Suspension | 1 | 489 | 1 |
| other | Asthenopia | Eye disorders | Azopt® 1% Ophthalmic Suspension | 1 | 475 | 1 |
| other | Blepharospasm | Eye disorders | Generic Brinzolamide 1% Ophthalmic Suspension | 0 | 489 | 0 |
| other | Blepharospasm | Eye disorders | Azopt® 1% Ophthalmic Suspension | 1 | 475 | 1 |
| other | Cataract nuclear | Eye disorders | Generic Brinzolamide 1% Ophthalmic Suspension | 1 | 489 | 1 |
| other | Cataract nuclear | Eye disorders | Azopt® 1% Ophthalmic Suspension | 0 | 475 | 0 |
1 to 10 of 130Source ClinicalTrials.gov
See all 130 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Generic Brinzolamide 1% Ophthalmic Suspension | ||
| Total, all-cause mortality | Azopt® 1% Ophthalmic Suspension | ||
| Total, other adverse events | Generic Brinzolamide 1% Ophthalmic Suspension | 55 | 489 |
| Total, other adverse events | Azopt® 1% Ophthalmic Suspension | 57 | 475 |
| Total, serious adverse events | Generic Brinzolamide 1% Ophthalmic Suspension | 0 | 489 |
| Total, serious adverse events | Azopt® 1% Ophthalmic Suspension | 0 | 475 |
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 |
|---|
| Generic Brinzolamide 1% Ophthalmic Suspension vs Azopt® 1% Ophthalmic Suspension: 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/NCT02512042
GET https://conductscience.org/api/trials/v1/NCT02512042/events?page=2