Trial · NCT03896633
Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt
NCT03896633, Phase 1, Phase 2, Completed, Bausch & Lomb Incorporated; results first posted 2021-06-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt. Trials, record NCT03896633. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03896633
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt
- NCT number
- NCT03896633
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 637 participants, actual
- Lead sponsor
- Bausch & Lomb Incorporated
- Conditions
- Glaucoma, Open Angle or Ocular Hypertension
- Interventions
- brinzolamide 1% ophthalmic suspension, Azopt 1%
- First posted
- 2019-04-01
- Last updated
- 2023-05-09
- Results first posted
- 2021-06-09
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Intraocular Pressure (IOP) | 6 weeks | |
| Other | Change in Intraocular Pressure (IOP) | 6 weeks | Change in intraocular pressure (IOP) from baseline (Eligibility Visit 2) and after treatment. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Intraocular Pressure (IOP) | 6 weeks | The Per Protocol Population was utilized for the primary outcome, included all randomized participants who met all inclusion/exclusion criteria, instilled 75% to 125% of the planned doses for the entire duration of the study, as verified by diaries, and who did not miss the scheduled applications for more than 3 consecutive days, and completed evaluations at Day 14 and Day 42 within the designated visit window (± 4 days) with no protocol deviations that would affect the treatment evaluation. | mmHg | MEAN |
| OTHER_PRE_SPECIFIED | Change in Intraocular Pressure (IOP) | 6 weeks | The Per Protocol Population was utilized for this outcome; included all randomized participants who met all inclusion/exclusion criteria, instilled 75% to 125% of the planned doses for the entire duration of the study, as verified by diaries, and who did not miss the scheduled applications for more than 3 consecutive days, and completed evaluations at Day 14 and Day 42 within the designated visit window (± 4 days) with no protocol deviations that would affect the treatment evaluation. | mmHg | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Intraocular Pressure (IOP) | Brinzolamide 1% Ophthalmic Suspension | 20.07 | Standard Deviation 3.269 | mmHg | |
| Intraocular Pressure (IOP) | Azopt 1% Ophthalmic Suspension | 19.89 | Standard Deviation 3.183 | mmHg | |
| Change in Intraocular Pressure (IOP) | Brinzolamide 1% Ophthalmic Suspension | -4.85 | Standard Deviation 2.792 | mmHg | |
| Change in Intraocular Pressure (IOP) | Azopt 1% Ophthalmic Suspension | -4.70 | Standard Deviation 2.861 | 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 | Brinzolamide 1% Ophthalmic Suspension | 321 | |
| Overall Study | STARTED | Azopt 1% Ophthalmic Suspension | 316 | |
| Overall Study | COMPLETED | Brinzolamide 1% Ophthalmic Suspension | 312 | |
| Overall Study | COMPLETED | Azopt 1% Ophthalmic Suspension | 306 | |
| Overall Study | NOT COMPLETED | Brinzolamide 1% Ophthalmic Suspension | 9 | |
| Overall Study | NOT COMPLETED | Azopt 1% Ophthalmic Suspension | 10 |
Source ClinicalTrials.gov
Adverse events6
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 | Dysgeusia | Nervous system disorders | Brinzolamide 1% Ophthalmic Suspension | 15 | 320 | |
| other | Dysgeusia | Nervous system disorders | Azopt 1% Ophthalmic Suspension | 22 | 318 | |
| serious | Abdominal pain upper | Gastrointestinal disorders | Brinzolamide 1% Ophthalmic Suspension | 0 | 320 | |
| serious | Abdominal pain upper | Gastrointestinal disorders | Azopt 1% Ophthalmic Suspension | 1 | 318 | |
| serious | Asthma | Respiratory, thoracic and mediastinal disorders | Brinzolamide 1% Ophthalmic Suspension | 0 | 320 | |
| serious | Asthma | Respiratory, thoracic and mediastinal disorders | Azopt 1% Ophthalmic Suspension | 1 | 318 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Brinzolamide 1% Ophthalmic Suspension | 0 | 320 |
| Total, all-cause mortality | Azopt 1% Ophthalmic Suspension | 0 | 318 |
| Total, other adverse events | Brinzolamide 1% Ophthalmic Suspension | 15 | 320 |
| Total, other adverse events | Azopt 1% Ophthalmic Suspension | 22 | 318 |
| Total, serious adverse events | Brinzolamide 1% Ophthalmic Suspension | 0 | 320 |
| Total, serious adverse events | Azopt 1% Ophthalmic Suspension | 2 | 318 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Brinzolamide 1% Ophthalmic Suspension vs Azopt 1% Ophthalmic Suspension: deaths from any cause | Trial comparisons |
| Brinzolamide 1% Ophthalmic Suspension vs Azopt 1% Ophthalmic Suspension: serious adverse events | 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/NCT03896633
GET https://conductscience.org/api/trials/v1/NCT03896633/registered