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 compared with AzoptTM
Detailed description
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) | 6 weeks |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Intraocular Pressure (IOP) | 6 weeks | Change in intraocular pressure (IOP) from baseline (Eligibility Visit 2) and after treatment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Brinzolamide 1% Ophthalmic Suspension ophthalmic suspension
brinzolamide 1% ophthalmic suspension: brinzolamide 1% ophthalmic suspension | 321 |
| Azopt 1% Ophthalmic Suspension Ophthalmic suspension
Azopt 1%: Azopt 1%, RLD | 316 |
| Total | 637 |
Baseline characteristics
| Characteristic | Azopt 1% Ophthalmic Suspension | Total | Brinzolamide 1% Ophthalmic Suspension |
|---|---|---|---|
| Age, Continuous | 63.8 years | 64.4 years | 65.1 years |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 9 Participants | 21 Participants | 12 Participants |
| Race (NIH/OMB) Black or African American | 81 Participants | 168 Participants | 87 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 223 Participants | 443 Participants | 220 Participants |
| Sex: Female, Male Female | 190 Participants | 389 Participants | 199 Participants |
| Sex: Female, Male Male | 126 Participants | 248 Participants | 122 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 320 | 0 / 318 |
| other Total, other adverse events | 15 / 320 | 22 / 318 |
| serious Total, serious adverse events | 0 / 320 | 2 / 318 |
Outcome results
Primary
Intraocular Pressure (IOP)
Time frame: 6 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brinzolamide 1% Ophthalmic Suspension | Intraocular Pressure (IOP) | 20.07 mmHg | Standard Deviation 3.269 |
| Azopt 1% Ophthalmic Suspension | Intraocular Pressure (IOP) | 19.89 mmHg | Standard Deviation 3.183 |
Other Pre-specified
Change in Intraocular Pressure (IOP)
Change in intraocular pressure (IOP) from baseline (Eligibility Visit 2) and after treatment.
Time frame: 6 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brinzolamide 1% Ophthalmic Suspension | Change in Intraocular Pressure (IOP) | -4.85 mmHg | Standard Deviation 2.792 |
| Azopt 1% Ophthalmic Suspension | Change in Intraocular Pressure (IOP) | -4.70 mmHg | Standard Deviation 2.861 |