Glaucoma, Open-Angle, Ocular Hypertension
Conditions
Brief summary
This study will evaluate 0.15% brimonidine tartrate in patients with primary open angle glaucoma and ocular hypertension.
Interventions
DRUG0.15% Brimonidine Tartrate
0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.
Sponsors
Allergan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Diagnosis of open-angle glaucoma or ocular hypertension
Exclusion criteria
* Used Alphagan® in previous 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Intraocular Pressure (IOP) in the Study Eye | Baseline, Month 3 | IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening). |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 0.15% Brimonidine Tartrate 0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months. | 376 |
| Total | 376 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 47 |
Baseline characteristics
| Characteristic | 0.15% Brimonidine Tartrate |
|---|---|
| Age, Continuous | 49.8 Years STANDARD_DEVIATION 17.4 |
| Sex: Female, Male Female | 161 Participants |
| Sex: Female, Male Male | 215 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 24 / 372 |
| serious Total, serious adverse events | 0 / 372 |
Outcome results
Primary
Change From Baseline in Intraocular Pressure (IOP) in the Study Eye
IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).
Time frame: Baseline, Month 3
Population: Intent-to-Treat: patients with baseline data and data at the indicated time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.15% Brimonidine Tartrate | Change From Baseline in Intraocular Pressure (IOP) in the Study Eye | Baseline | 25.4 Millimeters of Mercury (mmHg) | Standard Deviation 2.3 |
| 0.15% Brimonidine Tartrate | Change From Baseline in Intraocular Pressure (IOP) in the Study Eye | Change from Baseline at Month 3 (N=330) | -6.3 Millimeters of Mercury (mmHg) | Standard Deviation 3.5 |