Glaucoma, Ocular Hypertension
Conditions
Brief summary
This is a safety and efficacy study of fixed-combination bimatoprost and brimonidine compared with LUMIGAN® and ALPHAGAN® in patients with chronic glaucoma or ocular hypertension.
Interventions
DRUGFixed-Combination Bimatoprost/Brimonidine
One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.
One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening for 6 weeks.
DRUGVehicle Ophthalmic Solution
One drop vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.
DRUGBrimonidine Tartrate Ophthalmic Solution 0.2%
One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of ocular hypertension or glaucoma * Requires intraocular pressure (IOP)-lowering therapy
Exclusion criteria
* Cataract surgery in one eye * Ocular laser or intraocular surgery within 6 months * Refractive surgery in either eye * Anticipated use of contact lenses during the study * Expected use of artificial tears during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Average Eye Mean Diurnal Intraocular Pressure (IOP) | Baseline, Day 42 | IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Average Eye Mean Diurnal IOP | Baseline, Day 14, Day 28 | IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening). |
| Average Eye Mean Diurnal IOP | Day 14, Day 28, Day 42 | IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fixed-Combination Bimatoprost/Brimonidine One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks. | 38 |
| Bimatoprost Ophthalmic Solution 0.01% and Vehicle One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks. | 36 |
| Brimonidine Tartrate Ophthalmic Solution 0.2% One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks. | 38 |
| Total | 112 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Fixed-Combination Bimatoprost/Brimonidine | Bimatoprost Ophthalmic Solution 0.01% and Vehicle | Brimonidine Tartrate Ophthalmic Solution 0.2% | Total |
|---|---|---|---|---|
| Age, Customized <45 years | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Age, Customized >65 years | 16 Participants | 22 Participants | 18 Participants | 56 Participants |
| Age, Customized Between 45 and 65 years | 21 Participants | 14 Participants | 20 Participants | 55 Participants |
| Sex: Female, Male Female | 20 Participants | 22 Participants | 25 Participants | 67 Participants |
| Sex: Female, Male Male | 18 Participants | 14 Participants | 13 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 27 / 38 | 25 / 36 | 20 / 38 |
| serious Total, serious adverse events | 0 / 38 | 1 / 36 | 1 / 38 |
Outcome results
Primary
Change From Baseline in Average Eye Mean Diurnal Intraocular Pressure (IOP)
IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening).
Time frame: Baseline, Day 42
Population: Modified Intent to Treat: all randomized and treated patients who had baseline and at least 1 postbaseline IOP assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fixed-Combination Bimatoprost/Brimonidine | Change From Baseline in Average Eye Mean Diurnal Intraocular Pressure (IOP) | Baseline | 24.54 Millimeters of Mercury (mmHg) | Standard Deviation 1.712 |
| Fixed-Combination Bimatoprost/Brimonidine | Change From Baseline in Average Eye Mean Diurnal Intraocular Pressure (IOP) | Change from Baseline at Day 42 (N=38, 36, 37) | -6.79 Millimeters of Mercury (mmHg) | Standard Deviation 2.277 |
| Bimatoprost Ophthalmic Solution 0.01% and Vehicle | Change From Baseline in Average Eye Mean Diurnal Intraocular Pressure (IOP) | Baseline | 24.38 Millimeters of Mercury (mmHg) | Standard Deviation 2.022 |
| Bimatoprost Ophthalmic Solution 0.01% and Vehicle | Change From Baseline in Average Eye Mean Diurnal Intraocular Pressure (IOP) | Change from Baseline at Day 42 (N=38, 36, 37) | -6.63 Millimeters of Mercury (mmHg) | Standard Deviation 2.284 |
| Brimonidine Tartrate Ophthalmic Solution 0.2% | Change From Baseline in Average Eye Mean Diurnal Intraocular Pressure (IOP) | Baseline | 24.29 Millimeters of Mercury (mmHg) | Standard Deviation 1.457 |
| Brimonidine Tartrate Ophthalmic Solution 0.2% | Change From Baseline in Average Eye Mean Diurnal Intraocular Pressure (IOP) | Change from Baseline at Day 42 (N=38, 36, 37) | -3.92 Millimeters of Mercury (mmHg) | Standard Deviation 2.574 |
Secondary
Average Eye Mean Diurnal IOP
IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12.
Time frame: Day 14, Day 28, Day 42
Population: Modified Intent to Treat: all randomized and treated patients who had baseline and at least 1 postbaseline IOP assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fixed-Combination Bimatoprost/Brimonidine | Average Eye Mean Diurnal IOP | Day 28 | 17.29 mmHg | Standard Deviation 2.588 |
| Fixed-Combination Bimatoprost/Brimonidine | Average Eye Mean Diurnal IOP | Day 14 | 16.91 mmHg | Standard Deviation 2.004 |
| Fixed-Combination Bimatoprost/Brimonidine | Average Eye Mean Diurnal IOP | Day 42 (N=38, 36, 37) | 17.75 mmHg | Standard Deviation 2.505 |
| Bimatoprost Ophthalmic Solution 0.01% and Vehicle | Average Eye Mean Diurnal IOP | Day 28 | 17.40 mmHg | Standard Deviation 2.549 |
| Bimatoprost Ophthalmic Solution 0.01% and Vehicle | Average Eye Mean Diurnal IOP | Day 14 | 17.59 mmHg | Standard Deviation 2.363 |
| Bimatoprost Ophthalmic Solution 0.01% and Vehicle | Average Eye Mean Diurnal IOP | Day 42 (N=38, 36, 37) | 17.76 mmHg | Standard Deviation 2.467 |
| Brimonidine Tartrate Ophthalmic Solution 0.2% | Average Eye Mean Diurnal IOP | Day 14 | 19.61 mmHg | Standard Deviation 2.572 |
| Brimonidine Tartrate Ophthalmic Solution 0.2% | Average Eye Mean Diurnal IOP | Day 42 (N=38, 36, 37) | 20.34 mmHg | Standard Deviation 2.218 |
| Brimonidine Tartrate Ophthalmic Solution 0.2% | Average Eye Mean Diurnal IOP | Day 28 | 20.06 mmHg | Standard Deviation 2.54 |
Secondary
Change From Baseline in Average Eye Mean Diurnal IOP
IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening).
Time frame: Baseline, Day 14, Day 28
Population: Modified Intent to Treat: all randomized and treated patients who had baseline and at least 1 postbaseline IOP assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fixed-Combination Bimatoprost/Brimonidine | Change From Baseline in Average Eye Mean Diurnal IOP | Change from Baseline at Day 14 | -7.63 mmHg | Standard Deviation 2.152 |
| Fixed-Combination Bimatoprost/Brimonidine | Change From Baseline in Average Eye Mean Diurnal IOP | Baseline | 24.54 mmHg | Standard Deviation 1.712 |
| Fixed-Combination Bimatoprost/Brimonidine | Change From Baseline in Average Eye Mean Diurnal IOP | Change from Baseline at Day 28 | -7.25 mmHg | Standard Deviation 2.328 |
| Bimatoprost Ophthalmic Solution 0.01% and Vehicle | Change From Baseline in Average Eye Mean Diurnal IOP | Change from Baseline at Day 14 | -6.79 mmHg | Standard Deviation 1.997 |
| Bimatoprost Ophthalmic Solution 0.01% and Vehicle | Change From Baseline in Average Eye Mean Diurnal IOP | Baseline | 24.38 mmHg | Standard Deviation 2.022 |
| Bimatoprost Ophthalmic Solution 0.01% and Vehicle | Change From Baseline in Average Eye Mean Diurnal IOP | Change from Baseline at Day 28 | -6.98 mmHg | Standard Deviation 2.26 |
| Brimonidine Tartrate Ophthalmic Solution 0.2% | Change From Baseline in Average Eye Mean Diurnal IOP | Baseline | 24.29 mmHg | Standard Deviation 1.457 |
| Brimonidine Tartrate Ophthalmic Solution 0.2% | Change From Baseline in Average Eye Mean Diurnal IOP | Change from Baseline at Day 28 | -4.22 mmHg | Standard Deviation 2.869 |
| Brimonidine Tartrate Ophthalmic Solution 0.2% | Change From Baseline in Average Eye Mean Diurnal IOP | Change from Baseline at Day 14 | -4.67 mmHg | Standard Deviation 2.944 |