Ocular Hypertension, Primary Open Angle Glaucoma
Conditions
Brief summary
This is a randomized, Investigator-masked, multi-center, parallel group, therapeutic equivalence study with clinical endpoint.
Interventions
DRUGBrinzolamide ophthalmic suspension
dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks
DRUGAzopt®
dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks
Sponsors
Sun Pharmaceutical Industries Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or nonpregnant female aged 18 years or older with chronic open angle glaucoma or ocular hypertension in both eyes. * Provide signed and dated informed consent in accordance with good clinical practice and local legislation prior to any study procedure. * Be able and willing to follow study instructions and complete all required visits. * Subject requires treatment of both eyes and is able to discontinue use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo appropriate washout period.
Exclusion criteria
* Subjects with angle closure glaucoma * Females who are pregnant, breast feeding, or planning a pregnancy. * Females of childbearing potential who do not agree to utilize an adequate form of contraception. * Current, or past history of, severe hepatic or renal impairment * Current, or history within 2 months prior to baseline of, significant ocular disease * Functionally significant visual field loss * Contraindication to brinzolamide or sulfonamide therapy or known hypersensitivity to any component of brinzolamide or sulfonamide therapy * Subjects currently in another clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
India, Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BRIN-20-01 Brinzolamide ophthalmic suspension: dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks | 297 |
| Azopt® Azopt®: dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks | 300 |
| Total | 597 |
Baseline characteristics
| Characteristic | Azopt® | Total | BRIN-20-01 |
|---|---|---|---|
| Age, Continuous | 61.3 years STANDARD_DEVIATION 12.01 | 61.2 years STANDARD_DEVIATION 12 | 61.2 years STANDARD_DEVIATION 12.01 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 105 Participants | 204 Participants | 99 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 194 Participants | 392 Participants | 198 Participants |
| Sex: Female, Male Female | 174 Participants | 344 Participants | 170 Participants |
| Sex: Female, Male Male | 126 Participants | 253 Participants | 127 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 297 | 0 / 300 |
| other Total, other adverse events | 49 / 297 | 38 / 300 |
| serious Total, serious adverse events | 0 / 297 | 1 / 300 |
Outcome results
Primary
Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups
The recommended primary endpoint is the mean difference in Intraocular Pressure of both eyes between the two treatment groups at pre-specified time points.
Time frame: Baseline, Week 2 & Week 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BRIN-20-01 | Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups | Baseline- Left Eye 08:00 | 24.92 mmHg | Standard Deviation 2.29 |
| BRIN-20-01 | Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups | Baseline- Right Eye 08:00 | 24.87 mmHg | Standard Deviation 2.378 |
| BRIN-20-01 | Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups | Baseline - Left Eye 10:00 | 24.54 mmHg | Standard Deviation 2.307 |
| BRIN-20-01 | Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups | Baeline - Right Eye 10:00 | 24.52 mmHg | Standard Deviation 2.423 |
| BRIN-20-01 | Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups | Week 2 - Left Eye 08:00 | 19.87 mmHg | Standard Deviation 3.436 |
| BRIN-20-01 | Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups | Week 2 - Right Eye 08:00 | 19.81 mmHg | Standard Deviation 3.4 |
| BRIN-20-01 | Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups | Week 2 - Left Eye 10:00 | 18.87 mmHg | Standard Deviation 3.544 |
| BRIN-20-01 | Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups | Week 2 - Right Eye 10:00 | 18.69 mmHg | Standard Deviation 3.572 |
| BRIN-20-01 | Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups | Week 6 - Left Eye 08:00 | 18.86 mmHg | Standard Deviation 3.162 |
| BRIN-20-01 | Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups | Week 6 - Right Eye 08:00 | 18.87 mmHg | Standard Deviation 3.067 |
| BRIN-20-01 | Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups | Week 6 - Left Eye 10:00 | 17.76 mmHg | Standard Deviation 3.252 |
| BRIN-20-01 | Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups | Week 6 - Right Eye 10:00 | 17.71 mmHg | Standard Deviation 3.19 |
| Azopt® | Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups | Week 6 - Left Eye 10:00 | 17.73 mmHg | Standard Deviation 3.418 |
| Azopt® | Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups | Baseline- Left Eye 08:00 | 25.06 mmHg | Standard Deviation 2.363 |
| Azopt® | Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups | Week 2 - Left Eye 10:00 | 18.39 mmHg | Standard Deviation 3.76 |
| Azopt® | Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups | Baseline- Right Eye 08:00 | 25.12 mmHg | Standard Deviation 2.358 |
| Azopt® | Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups | Week 6 - Right Eye 08:00 | 18.99 mmHg | Standard Deviation 3.123 |
| Azopt® | Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups | Baseline - Left Eye 10:00 | 24.83 mmHg | Standard Deviation 2.389 |
| Azopt® | Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups | Week 2 - Right Eye 10:00 | 18.47 mmHg | Standard Deviation 3.468 |
| Azopt® | Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups | Baeline - Right Eye 10:00 | 24.90 mmHg | Standard Deviation 2.365 |
| Azopt® | Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups | Week 6 - Right Eye 10:00 | 17.70 mmHg | Standard Deviation 3.162 |
| Azopt® | Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups | Week 2 - Left Eye 08:00 | 19.56 mmHg | Standard Deviation 3.642 |
| Azopt® | Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups | Week 6 - Left Eye 08:00 | 18.91 mmHg | Standard Deviation 3.333 |
| Azopt® | Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups | Week 2 - Right Eye 08:00 | 19.62 mmHg | Standard Deviation 3.423 |
95% CI: [-0.28, 0.91]
95% CI: [-0.39, 0.76]
95% CI: [-0.59, 0.5]
95% CI: [-0.64, 0.4]
Secondary
Change From Baseline in IOP of Both Eyes Between the 2 Treatment Groups.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BRIN-20-01 | Change From Baseline in IOP of Both Eyes Between the 2 Treatment Groups. | Week 2 - Right Eye 10:00 | -5.82 mmHg | Standard Deviation 3.484 |
| BRIN-20-01 | Change From Baseline in IOP of Both Eyes Between the 2 Treatment Groups. | Week 2- Left Eye 08:00 | -4.67 mmHg | Standard Deviation 3.441 |
| BRIN-20-01 | Change From Baseline in IOP of Both Eyes Between the 2 Treatment Groups. | Week 2- Right Eye 08:00 | -4.71 mmHg | Standard Deviation 3.286 |
| BRIN-20-01 | Change From Baseline in IOP of Both Eyes Between the 2 Treatment Groups. | Week 2- Left Eye 10:00 | -5.68 mmHg | Standard Deviation 3.475 |
| BRIN-20-01 | Change From Baseline in IOP of Both Eyes Between the 2 Treatment Groups. | Week 6- Left Eye 08:00 | -5.68 mmHg | Standard Deviation 3.29 |
| BRIN-20-01 | Change From Baseline in IOP of Both Eyes Between the 2 Treatment Groups. | Week 6- Right Eye 08:00 | -5.64 mmHg | Standard Deviation 3.107 |
| BRIN-20-01 | Change From Baseline in IOP of Both Eyes Between the 2 Treatment Groups. | Week 6 - Left Eye 10:00 | -6.78 mmHg | Standard Deviation 3.329 |
| BRIN-20-01 | Change From Baseline in IOP of Both Eyes Between the 2 Treatment Groups. | Week 6 - Right Eye 10:00 | -6.81 mmHg | Standard Deviation 3.239 |
| Azopt® | Change From Baseline in IOP of Both Eyes Between the 2 Treatment Groups. | Week 6 - Right Eye 10:00 | -7.20 mmHg | Standard Deviation 3.5 |
| Azopt® | Change From Baseline in IOP of Both Eyes Between the 2 Treatment Groups. | Week 6- Left Eye 08:00 | -5.92 mmHg | Standard Deviation 3.577 |
| Azopt® | Change From Baseline in IOP of Both Eyes Between the 2 Treatment Groups. | Week 2- Left Eye 08:00 | -5.27 mmHg | Standard Deviation 3.617 |
| Azopt® | Change From Baseline in IOP of Both Eyes Between the 2 Treatment Groups. | Week 6 - Left Eye 10:00 | -7.10 mmHg | Standard Deviation 3.614 |
| Azopt® | Change From Baseline in IOP of Both Eyes Between the 2 Treatment Groups. | Week 2- Right Eye 08:00 | -5.28 mmHg | Standard Deviation 3.531 |
| Azopt® | Change From Baseline in IOP of Both Eyes Between the 2 Treatment Groups. | Week 6- Right Eye 08:00 | -5.91 mmHg | Standard Deviation 3.468 |
| Azopt® | Change From Baseline in IOP of Both Eyes Between the 2 Treatment Groups. | Week 2- Left Eye 10:00 | -6.44 mmHg | Standard Deviation 3.717 |
| Azopt® | Change From Baseline in IOP of Both Eyes Between the 2 Treatment Groups. | Week 2 - Right Eye 10:00 | -6.43 mmHg | Standard Deviation 3.63 |
p-value: 0.0015two-sample t-test
p-value: 0.0008two-sample t-test
p-value: <0.0001two-sample t-test
p-value: <0.0001two-sample t-test