Glaucoma, Open Angle or Ocular Hypertension
Conditions
Brief summary
The main purpose of this prospective study is to demonstrate the therapeutic equivalence of topical brinzolamide dosed three times daily compared with AzoptTM (brinzolamide ophthalmic suspension 1%) dosed three times daily in IOP reduction in patients with POAG or OH.
Interventions
brinzolamide 1% ophthalmic suspension
DRUGAzopt 1%
Azopt 1%, RLD
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and females 18 years of age or older, * diagnosed with primary open-angle glaucoma or ocular hypertension.
Exclusion criteria
* Patients with any form of glaucoma (such as secondary, congenital, juvenile or normal tension glaucoma, angle closure glaucoma) in either eye other than primary open-angle glaucoma, * ocular hypertension.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraocular Pressure (IOP) at Week 12 | Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Change in Intraocular Pressure (IOP) From Baseline to Week 12 | Baseline, Week 12 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Brinzolamide 1% Ophthalmic Suspension ophthalmic suspension
brinzolamide 1% ophthalmic suspension: brinzolamide 1% ophthalmic suspension | 129 |
| Azopt 1% Ophthalmic Suspension Ophthalmic suspension
Azopt 1%: Azopt 1%, RLD | 129 |
| Total | 258 |
Baseline characteristics
| Characteristic | Azopt 1% Ophthalmic Suspension | Total | Brinzolamide 1% Ophthalmic Suspension |
|---|---|---|---|
| Age, Continuous | 65.3 years | 64.6 years | 64.1 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 32 Participants | 61 Participants | 29 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 | 97 Participants | 194 Participants | 97 Participants |
| Sex: Female, Male Female | 81 Participants | 159 Participants | 78 Participants |
| Sex: Female, Male Male | 48 Participants | 99 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 129 | 0 / 129 |
| other Total, other adverse events | 9 / 129 | 5 / 129 |
| serious Total, serious adverse events | 2 / 129 | 3 / 129 |
Outcome results
Primary
Intraocular Pressure (IOP) at Week 12
Time frame: Week 12
Population: The Per Protocol (PP) Population was utilized for the primary outcome. All randomized participants who completed both the baseline visit (eligibility visit 2) and the week 12 visit and who had no major protocol violations, and who also completed week 4 and week 8 visits, were included in the PP population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brinzolamide 1% Ophthalmic Suspension | Intraocular Pressure (IOP) at Week 12 | 20.6 mmHg | Standard Deviation 3.21 |
| Azopt 1% Ophthalmic Suspension | Intraocular Pressure (IOP) at Week 12 | 20.8 mmHg | Standard Deviation 3.37 |
Secondary
Change in Intraocular Pressure (IOP) From Baseline to Week 12
Time frame: Baseline, Week 12
Population: The Per Protocol (PP) Population was utilized for the secondary outcome. All randomized participants who completed both the baseline visit (eligibility visit 2) and the week 12 visit and who had no major protocol violations, and who also completed week 4 and week 8 visits, were included in the PP population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brinzolamide 1% Ophthalmic Suspension | Change in Intraocular Pressure (IOP) From Baseline to Week 12 | -5.3 mmHg | Standard Deviation 2.79 |
| Azopt 1% Ophthalmic Suspension | Change in Intraocular Pressure (IOP) From Baseline to Week 12 | -5.4 mmHg | Standard Deviation 3.27 |