Glaucoma, Ocular Hypertension
Conditions
Brief summary
This study will evaluate the safety and efficacy of bimatoprost/timolol formulation A ophthalmic solution with Ganfort® (bimatoprost 0.03%/timolol 0.5% ophthalmic solution) once daily for 12 weeks in patients with glaucoma or ocular hypertension.
Interventions
DRUGbimatoprost /timolol formulation A fixed combination ophthalmic solution
One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
DRUGbimatoprost/timolol fixed combination ophthalmic solution
One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient has ocular hypertension or glaucoma in both eyes * Requires IOP-lowering therapy in each eye
Exclusion criteria
* Active or recurrent eye disease that would interfere with interpretation of study data in either eye * History of any eye surgery or laser in either eye within 6 months * Required chronic use of other eye medications during the study * Anticipated wearing of contact lenses during the study. * Intermittent use of oral, intramuscular, or intravenous corticosteroids within 21 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 | Baseline, Week 12 | Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. A negative number change from baseline indicates a reduction in IOP (improvement). |
| Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 2 | Week 2 | Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 2 at Hour 0, Hour 2 and Hour 8. |
| Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 6 | Week 6 | Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 6 at Hour 0, Hour 2 and Hour 8. |
| Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 | Week 12 | Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 12 at Hour 0, Hour 2 and Hour 8. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12 | Baseline, Week 12 | Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. A negative number change from baseline indicates a reduction in IOP (improvement). |
| Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12 | Baseline, Week 12 | Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8. Average eye IOP is defined as the average of the IOP in both eyes. A negative number change from baseline indicates a reduction in IOP (improvement). |
Countries
Australia, Czechia, Germany, Hungary, Israel, Russia, Spain, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bimatoprost/Timolol Formulation A One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks. | 278 |
| Bimatoprost/Timolol Fixed Combination Ophthalmic Solution One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks. | 283 |
| Total | 561 |
Baseline characteristics
| Characteristic | Bimatoprost/Timolol Formulation A | Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | Total |
|---|---|---|---|
| Age, Customized 45 to 65 Years | 132 Participants | 135 Participants | 267 Participants |
| Age, Customized <45 Years | 12 Participants 10.61 | 13 Participants 10.82 | 25 Participants 10.71 |
| Age, Customized >65 Years | 134 Participants | 135 Participants | 269 Participants |
| Sex: Female, Male Female | 159 Participants | 162 Participants | 321 Participants |
| Sex: Female, Male Male | 119 Participants | 121 Participants | 240 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 59 / 278 | 55 / 282 |
| serious Total, serious adverse events | 4 / 278 | 4 / 282 |
Outcome results
Primary
Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12
Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 12 at Hour 0, Hour 2 and Hour 8.
Time frame: Week 12
Population: Intent-to-treat population included all randomized participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bimatoprost/Timolol Formulation A | Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 | Week 12_Hour 0 | 16.29 mm Hg | Standard Deviation 2.783 |
| Bimatoprost/Timolol Formulation A | Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 | Week 12_Hour 2 | 16.18 mm Hg | Standard Deviation 2.845 |
| Bimatoprost/Timolol Formulation A | Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 | Week 12_Hour 8 | 15.85 mm Hg | Standard Deviation 2.786 |
| Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 | Week 12_Hour 0 | 16.56 mm Hg | Standard Deviation 2.643 |
| Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 | Week 12_Hour 2 | 16.37 mm Hg | Standard Deviation 2.699 |
| Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 | Week 12_Hour 8 | 16.09 mm Hg | Standard Deviation 2.714 |
Primary
Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 2
Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 2 at Hour 0, Hour 2 and Hour 8.
Time frame: Week 2
Population: Intent-to-treat population included all randomized participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bimatoprost/Timolol Formulation A | Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 2 | Week 2_Hour 0 | 16.23 mm Hg | Standard Deviation 2.746 |
| Bimatoprost/Timolol Formulation A | Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 2 | Week 2_Hour 2 | 16.05 mm Hg | Standard Deviation 2.877 |
| Bimatoprost/Timolol Formulation A | Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 2 | Week 2_Hour 8 | 15.49 mm Hg | Standard Deviation 2.596 |
| Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 2 | Week 2_Hour 0 | 16.49 mm Hg | Standard Deviation 2.887 |
| Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 2 | Week 2_Hour 2 | 16.23 mm Hg | Standard Deviation 2.826 |
| Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 2 | Week 2_Hour 8 | 15.83 mm Hg | Standard Deviation 2.987 |
Primary
Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 6
Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 6 at Hour 0, Hour 2 and Hour 8.
Time frame: Week 6
Population: Intent-to-treat population included all randomized participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bimatoprost/Timolol Formulation A | Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 6 | Week 6_Hour 0 | 16.28 mm Hg | Standard Deviation 2.754 |
| Bimatoprost/Timolol Formulation A | Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 6 | Week 6_Hour 2 | 15.90 mm Hg | Standard Deviation 2.91 |
| Bimatoprost/Timolol Formulation A | Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 6 | Week 6_Hour 8 | 15.71 mm Hg | Standard Deviation 2.755 |
| Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 6 | Week 6_Hour 0 | 16.31 mm Hg | Standard Deviation 2.874 |
| Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 6 | Week 6_Hour 2 | 16.17 mm Hg | Standard Deviation 2.894 |
| Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 6 | Week 6_Hour 8 | 15.82 mm Hg | Standard Deviation 2.926 |
Primary
Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12
Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. A negative number change from baseline indicates a reduction in IOP (improvement).
Time frame: Baseline, Week 12
Population: Per-protocol population included randomized participants who did not have a protocol violation that significantly affected the conduct or the results of the trial.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bimatoprost/Timolol Formulation A | Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 | Baseline_Hour 0 | 25.41 mm Hg | Standard Deviation 2.232 |
| Bimatoprost/Timolol Formulation A | Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 | Baseline_Hour 2 (n=255,260) | 24.79 mm Hg | Standard Deviation 2.676 |
| Bimatoprost/Timolol Formulation A | Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 | Baseline_Hour 8 (n=254,259) | 23.88 mm Hg | Standard Deviation 3.008 |
| Bimatoprost/Timolol Formulation A | Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 | Change from baseline at Week 12_Hour 0 (n=244,237) | -9.06 mm Hg | Standard Deviation 3.216 |
| Bimatoprost/Timolol Formulation A | Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 | Change from baseline at Week 12_Hour 2 (n=235,235) | -8.53 mm Hg | Standard Deviation 3.52 |
| Bimatoprost/Timolol Formulation A | Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 | Change from baseline at Week 12_Hour 8 (n=237,234) | -7.98 mm Hg | Standard Deviation 3.435 |
| Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 | Change from baseline at Week 12_Hour 2 (n=235,235) | -8.38 mm Hg | Standard Deviation 3.297 |
| Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 | Baseline_Hour 0 | 25.38 mm Hg | Standard Deviation 2.209 |
| Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 | Change from baseline at Week 12_Hour 0 (n=244,237) | -8.72 mm Hg | Standard Deviation 3.088 |
| Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 | Baseline_Hour 2 (n=255,260) | 24.72 mm Hg | Standard Deviation 2.47 |
| Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 | Change from baseline at Week 12_Hour 8 (n=237,234) | -7.72 mm Hg | Standard Deviation 3.172 |
| Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 | Baseline_Hour 8 (n=254,259) | 23.82 mm Hg | Standard Deviation 2.747 |
Secondary
Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12
Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8. Average eye IOP is defined as the average of the IOP in both eyes. A negative number change from baseline indicates a reduction in IOP (improvement).
Time frame: Baseline, Week 12
Population: Intent-to-treat population included all randomized participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bimatoprost/Timolol Formulation A | Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12 | Baseline_Hour 0 | 24.94 mm Hg | Standard Deviation 2.116 |
| Bimatoprost/Timolol Formulation A | Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12 | Baseline_Hour 2 | 24.29 mm Hg | Standard Deviation 2.515 |
| Bimatoprost/Timolol Formulation A | Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12 | Baseline_Hour 8 | 23.42 mm Hg | Standard Deviation 2.904 |
| Bimatoprost/Timolol Formulation A | Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12 | Change from baseline at Week 12_Hour 0 | -8.65 mm Hg | Standard Deviation 3.109 |
| Bimatoprost/Timolol Formulation A | Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12 | Change from baseline at Week 12_Hour 2 | -8.11 mm Hg | Standard Deviation 3.392 |
| Bimatoprost/Timolol Formulation A | Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12 | Change from baseline at Week 12_Hour 8 | -7.57 mm Hg | Standard Deviation 3.395 |
| Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12 | Change from baseline at Week 12_Hour 2 | -7.86 mm Hg | Standard Deviation 3.413 |
| Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12 | Baseline_Hour 0 | 24.86 mm Hg | Standard Deviation 2.131 |
| Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12 | Change from baseline at Week 12_Hour 0 | -8.30 mm Hg | Standard Deviation 3.009 |
| Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12 | Baseline_Hour 2 | 24.23 mm Hg | Standard Deviation 2.426 |
| Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12 | Change from baseline at Week 12_Hour 8 | -7.27 mm Hg | Standard Deviation 3.226 |
| Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12 | Baseline_Hour 8 | 23.36 mm Hg | Standard Deviation 2.703 |
Secondary
Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12
Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. A negative number change from baseline indicates a reduction in IOP (improvement).
Time frame: Baseline, Week 12
Population: Intent-to-treat population included all randomized participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bimatoprost/Timolol Formulation A | Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12 | Baseline_Hour 0 | 25.34 mm Hg | Standard Deviation 2.233 |
| Bimatoprost/Timolol Formulation A | Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12 | Baseline_Hour 2 | 24.71 mm Hg | Standard Deviation 2.7 |
| Bimatoprost/Timolol Formulation A | Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12 | Baseline_Hour 8 | 23.81 mm Hg | Standard Deviation 2.989 |
| Bimatoprost/Timolol Formulation A | Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12 | Change from baseline at Week 12_Hour 0 | -8.94 mm Hg | Standard Deviation 3.29 |
| Bimatoprost/Timolol Formulation A | Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12 | Change from baseline at Week 12_Hour 2 | -8.44 mm Hg | Standard Deviation 3.646 |
| Bimatoprost/Timolol Formulation A | Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12 | Change from baseline at Week 12_Hour 8 | -7.87 mm Hg | Standard Deviation 3.496 |
| Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12 | Change from baseline at Week 12_Hour 2 | -8.08 mm Hg | Standard Deviation 3.504 |
| Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12 | Baseline_Hour 0 | 25.30 mm Hg | Standard Deviation 2.244 |
| Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12 | Change from baseline at Week 12_Hour 0 | -8.51 mm Hg | Standard Deviation 3.253 |
| Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12 | Baseline_Hour 2 | 24.61 mm Hg | Standard Deviation 2.536 |
| Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12 | Change from baseline at Week 12_Hour 8 | -7.52 mm Hg | Standard Deviation 3.362 |
| Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12 | Baseline_Hour 8 | 23.80 mm Hg | Standard Deviation 2.795 |