Trial · NCT05022004
A Therapeutic Equivalence Study in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
NCT05022004, Phase 3, Completed, Sun Pharmaceutical Industries Limited; results first posted 2024-01-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Therapeutic Equivalence Study in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension. Trials, record NCT05022004. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05022004
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Therapeutic Equivalence Study in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
- NCT number
- NCT05022004
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 599 participants, actual
- Lead sponsor
- Sun Pharmaceutical Industries Limited
- Conditions
- Primary Open Angle Glaucoma, Ocular Hypertension
- Interventions
- Brinzolamide ophthalmic suspension, Azopt®
- First posted
- 2021-08-26
- Last updated
- 2024-01-18
- Results first posted
- 2024-01-18
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups | Baseline, Week 2 & Week 6 | The recommended primary endpoint is the mean difference in Intraocular Pressure of both eyes between the two treatment groups at pre-specified time points. |
| Secondary | Change From Baseline in IOP of Both Eyes Between the 2 Treatment Groups. | approximately 8:00 AM. (hour 0; before the morning drop) and 10:00 AM. (hour 2) at the Day 14 (Week 2) and Day 42 (Week 6) visits |
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 | Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups | Baseline, Week 2 & Week 6 | mmHg | MEAN | |
| SECONDARY | Change From Baseline in IOP of Both Eyes Between the 2 Treatment Groups. | approximately 8:00 AM. (hour 0; before the morning drop) and 10:00 AM. (hour 2) at the Day 14 (Week 2) and Day 42 (Week 6) visits | mmHg | MEAN |
Source ClinicalTrials.gov
Results by group40
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 of Both Eyes Between the Two Treatment Groups | BRIN-20-01 | Baseline- Left Eye 08:00 | 24.92 | Standard Deviation 2.290 | mmHg |
| Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups | Azopt® | Baseline- Left Eye 08:00 | 25.06 | Standard Deviation 2.363 | mmHg |
| Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups | BRIN-20-01 | Baseline- Right Eye 08:00 | 24.87 | Standard Deviation 2.378 | mmHg |
| Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups | Azopt® | Baseline- Right Eye 08:00 | 25.12 | Standard Deviation 2.358 | mmHg |
| Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups | BRIN-20-01 | Baseline - Left Eye 10:00 | 24.54 | Standard Deviation 2.307 | mmHg |
| Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups | Azopt® | Baseline - Left Eye 10:00 | 24.83 | Standard Deviation 2.389 | mmHg |
| Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups | BRIN-20-01 | Baeline - Right Eye 10:00 | 24.52 | Standard Deviation 2.423 | mmHg |
| Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups | Azopt® | Baeline - Right Eye 10:00 | 24.90 | Standard Deviation 2.365 | mmHg |
| Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups | BRIN-20-01 | Week 2 - Left Eye 08:00 | 19.87 | Standard Deviation 3.436 | mmHg |
| Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups | Azopt® | Week 2 - Left Eye 08:00 | 19.56 | Standard Deviation 3.642 | mmHg |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | BRIN-20-01 | 297 | |
| Overall Study | STARTED | Azopt® | 300 | |
| Overall Study | COMPLETED | BRIN-20-01 | 287 | |
| Overall Study | COMPLETED | Azopt® | 289 | |
| Overall Study | NOT COMPLETED | BRIN-20-01 | 10 | |
| Overall Study | NOT COMPLETED | Azopt® | 11 |
Source ClinicalTrials.gov
Adverse events102
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 | Arrhythmia | Cardiac disorders | BRIN-20-01 | 1 | 297 | |
| other | Arrhythmia | Cardiac disorders | Azopt® | 0 | 300 | |
| other | Abnormal Sensation in Eye | Eye disorders | BRIN-20-01 | 1 | 297 | |
| other | Abnormal Sensation in Eye | Eye disorders | Azopt® | 0 | 300 | |
| other | Blepharitis | Eye disorders | BRIN-20-01 | 1 | 297 | |
| other | Blepharitis | Eye disorders | Azopt® | 1 | 300 | |
| other | Cataract | Eye disorders | BRIN-20-01 | 1 | 297 | |
| other | Cataract | Eye disorders | Azopt® | 0 | 300 | |
| other | Conjunctival Hyperemia | Eye disorders | BRIN-20-01 | 3 | 297 | |
| other | Conjunctival Hyperemia | Eye disorders | Azopt® | 2 | 300 |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BRIN-20-01 | 0 | 297 |
| Total, all-cause mortality | Azopt® | 0 | 300 |
| Total, other adverse events | BRIN-20-01 | 49 | 297 |
| Total, other adverse events | Azopt® | 38 | 300 |
| Total, serious adverse events | BRIN-20-01 | 0 | 297 |
| Total, serious adverse events | Azopt® | 1 | 300 |
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 |
|---|---|
| BRIN-20-01 vs Azopt®: deaths from any cause | Trial comparisons |
| BRIN-20-01 vs Azopt®: 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/NCT05022004
GET https://conductscience.org/api/trials/v1/NCT05022004/results?page=2