Ocular Hypertension, Open-angle Glaucoma
Conditions
Brief summary
This study will evaluate the efficacy and safety of brimonidine 0.1% three-times daily in patients with glaucoma or ocular hypertension
Interventions
DRUGbrimonidine 0.1% (Alphagan® P)
Brimonidine 0.1%, 1 drop three-times daily for 4 weeks
Sponsors
Allergan
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* patients with open-angle glaucoma or ocular hypertension
Exclusion criteria
* allergy to brimonidine * inability to complete 24 hour stay for monitoring
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular Pressure (IOP) for a 24-Hour Period at Week 4 | Week 4 | IOP for a 24-hour period separated into diurnal(7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at week 4. IOP is a measurement of the fluid pressure inside the eye. Measurements of IOP were taken in the sitting and supine (laying down face up) body positions during the 16-hour diurnal (awake) period and in the supine position during the 8-hour nocturnal (sleep) period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Intraocular Pressure (IOP) for a 24-Hour Period at Week 4 | Baseline, Week 4 | Change from baseline in IOP for a 24-hour period separated into diurnal (7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at week 4. IOP is a measurement of the fluid pressure inside the eey. Measurements of IOP were taken in the sitting and supine (laying down face up) body positions during the 16-hour diurnal (awake) period and in the supine position during the 8-hour nocturnal (sleep) period. A negative number change from baseline indicates an improvement. |
| Ocular Perfusion Pressure (OPP) for a 24-Hour Period at Week 4 | Week 4 | Ocular perfusion pressure (OPP) calculated for a 24-hour period separated into diurnal (7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at week 4. Ocular perfusion pressure is blood pressure minus the intraocular pressure, which is a measurement of the fluid pressure inside the eye. Measurements of IOP and blood pressure were taken in the sitting and supine (laying down face up) body positions during the 16-hour diurnal (awake) period and in the supine position during the 8-hour nocturnal (sleep) period. |
| Change in Ocular Perfusion Pressure (OPP) Over a 24-Hour Period at Week 4 | Week 4 | Change in ocular perfusion pressure (OPP) calculated over a 24-hour period separated into diurnal (7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at Week 4. Ocular perfusion pressure is blood pressure minus the intraocular pressure, which is a measurement of the fluid pressure inside the eye. Measurements of IOP and blood pressure were taken in the sitting and supine (laying down face up) body positions during the 16-hour (awake) period and in the supine position during the 8-hour nocturnal (sleep) period. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Brimonidine 0.1% Brimonidine 0.1% | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Brimonidine 0.1% |
|---|---|
| Age Continuous | 58.3 years STANDARD_DEVIATION 7.8 |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Intraocular Pressure (IOP) for a 24-Hour Period at Week 4
IOP for a 24-hour period separated into diurnal(7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at week 4. IOP is a measurement of the fluid pressure inside the eye. Measurements of IOP were taken in the sitting and supine (laying down face up) body positions during the 16-hour diurnal (awake) period and in the supine position during the 8-hour nocturnal (sleep) period.
Time frame: Week 4
Population: Intent to Treat defined as all patients who started the study (randomized)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brimonidine 0.1% | Intraocular Pressure (IOP) for a 24-Hour Period at Week 4 | Diurnal IOP Sitting at Week 4 | 16.8 Millimeters of mercury (mmHg) | Standard Deviation 2.8 |
| Brimonidine 0.1% | Intraocular Pressure (IOP) for a 24-Hour Period at Week 4 | Diurnal IOP Supine at Week 4 | 21.1 Millimeters of mercury (mmHg) | Standard Deviation 2.3 |
| Brimonidine 0.1% | Intraocular Pressure (IOP) for a 24-Hour Period at Week 4 | Nocturnal IOP Supine at Week 4 | 23.0 Millimeters of mercury (mmHg) | Standard Deviation 2.8 |
Secondary
Change From Baseline in Intraocular Pressure (IOP) for a 24-Hour Period at Week 4
Change from baseline in IOP for a 24-hour period separated into diurnal (7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at week 4. IOP is a measurement of the fluid pressure inside the eey. Measurements of IOP were taken in the sitting and supine (laying down face up) body positions during the 16-hour diurnal (awake) period and in the supine position during the 8-hour nocturnal (sleep) period. A negative number change from baseline indicates an improvement.
Time frame: Baseline, Week 4
Population: Intent to Treat defined as all patients who started the study (randomized)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brimonidine 0.1% | Change From Baseline in Intraocular Pressure (IOP) for a 24-Hour Period at Week 4 | Diurnal IOP Sitting at Baseline | 19.2 Millimeters of mercury (mmHg) | Standard Deviation 2.7 |
| Brimonidine 0.1% | Change From Baseline in Intraocular Pressure (IOP) for a 24-Hour Period at Week 4 | Diurnal IOP Supine at Baseline | 23.1 Millimeters of mercury (mmHg) | Standard Deviation 2.1 |
| Brimonidine 0.1% | Change From Baseline in Intraocular Pressure (IOP) for a 24-Hour Period at Week 4 | Nocturnal IOP Supine at Baseline | 22.7 Millimeters of mercury (mmHg) | Standard Deviation 2.6 |
| Brimonidine 0.1% | Change From Baseline in Intraocular Pressure (IOP) for a 24-Hour Period at Week 4 | Diurnal IOP Sitting Change from Baseline at Week 4 | -2.4 Millimeters of mercury (mmHg) | Standard Deviation 1.4 |
| Brimonidine 0.1% | Change From Baseline in Intraocular Pressure (IOP) for a 24-Hour Period at Week 4 | Diurnal IOP Supine Change from Baseline at Week 4 | -1.9 Millimeters of mercury (mmHg) | Standard Deviation 1.3 |
| Brimonidine 0.1% | Change From Baseline in Intraocular Pressure (IOP) for a 24-Hour Period at Week 4 | Nocturnal IOP Supine Change from Baseline at Wk 4 | 0.3 Millimeters of mercury (mmHg) | Standard Deviation 1.9 |
Secondary
Change in Ocular Perfusion Pressure (OPP) Over a 24-Hour Period at Week 4
Change in ocular perfusion pressure (OPP) calculated over a 24-hour period separated into diurnal (7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at Week 4. Ocular perfusion pressure is blood pressure minus the intraocular pressure, which is a measurement of the fluid pressure inside the eye. Measurements of IOP and blood pressure were taken in the sitting and supine (laying down face up) body positions during the 16-hour (awake) period and in the supine position during the 8-hour nocturnal (sleep) period.
Time frame: Week 4
Population: Intent to Treat defined as all patients who started the study (randomized)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brimonidine 0.1% | Change in Ocular Perfusion Pressure (OPP) Over a 24-Hour Period at Week 4 | Diurnal Change in OPP Sitting at Week 4 | 1.1 Millimeters of mercury (mmHg) | Standard Deviation 5.6 |
| Brimonidine 0.1% | Change in Ocular Perfusion Pressure (OPP) Over a 24-Hour Period at Week 4 | Diurnal Change in OPP Supine at Week 4 | 0.3 Millimeters of mercury (mmHg) | Standard Deviation 4.9 |
| Brimonidine 0.1% | Change in Ocular Perfusion Pressure (OPP) Over a 24-Hour Period at Week 4 | Nocturnal Change in OPP Supine at Week 4 | -3.0 Millimeters of mercury (mmHg) | Standard Deviation 6.1 |
Secondary
Ocular Perfusion Pressure (OPP) for a 24-Hour Period at Week 4
Ocular perfusion pressure (OPP) calculated for a 24-hour period separated into diurnal (7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at week 4. Ocular perfusion pressure is blood pressure minus the intraocular pressure, which is a measurement of the fluid pressure inside the eye. Measurements of IOP and blood pressure were taken in the sitting and supine (laying down face up) body positions during the 16-hour diurnal (awake) period and in the supine position during the 8-hour nocturnal (sleep) period.
Time frame: Week 4
Population: Intent to Treat defined as all patients who started the study (randomized)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brimonidine 0.1% | Ocular Perfusion Pressure (OPP) for a 24-Hour Period at Week 4 | Diurnal OPP Sitting at Week 4 | 46.8 Millimeters of mercury (mmHg) | Standard Deviation 7.6 |
| Brimonidine 0.1% | Ocular Perfusion Pressure (OPP) for a 24-Hour Period at Week 4 | Diurnal OPP Supine at Week 4 | 53.8 Millimeters of mercury (mmHg) | Standard Deviation 9.8 |
| Brimonidine 0.1% | Ocular Perfusion Pressure (OPP) for a 24-Hour Period at Week 4 | Nocturnal OPP Supine at Week 4 | 49.2 Millimeters of mercury (mmHg) | Standard Deviation 11.2 |