Glaucoma, Ocular Hypertension
Conditions
Brief summary
This study will evaluate the safety and efficacy of bimatoprost 0.03% formulation B ophthalmic solution with LUMIGAN® (bimatoprost ophthalmic solution 0.03%) once daily for 12 weeks in patients with glaucoma or ocular hypertension
Interventions
DRUGBimatoprost 0.03% Formulation B Ophthalmic Solution
One drop administered in each eye, every evening, for 12 weeks
One drop administered in each eye, every evening, 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 Week 12 | Baseline, Week 12 | Change from baseline in worse eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements in the worse eye were evaluated at hours 0, 2, and 8. A negative number change from baseline indicated a reduction in IOP, and a positive number change from baseline indicated an increase in IOP. |
| Average Eye IOP at Week 12 | Baseline, Week 12 | Average Eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported. Baseline data are included for reference only. |
| Average Eye IOP at Week 6 | Week 6 | Average Eye IOP at Week 6 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported. |
| Average Eye IOP at Week 2 | Week 2 | Average Eye IOP at Week 2 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bimatoprost 0.03% Formulation B Ophthalmic Solution Bimatoprost 0.03% Formulation B Ophthalmic Solution | 302 |
| Bimatoprost 0.03% Ophthalmic Solution Bimatoprost 0.03% Ophthalmic Solution | 295 |
| Total | 597 |
Baseline characteristics
| Characteristic | Bimatoprost 0.03% Formulation B Ophthalmic Solution | Bimatoprost 0.03% Ophthalmic Solution | Total |
|---|---|---|---|
| Age, Customized <45 years | 8 Participants | 11 Participants | 19 Participants |
| Age, Customized >65 years | 135 Participants | 150 Participants | 285 Participants |
| Age, Customized Between 45 and 65 years | 159 Participants | 134 Participants | 293 Participants |
| Sex: Female, Male Female | 170 Participants | 181 Participants | 351 Participants |
| Sex: Female, Male Male | 132 Participants | 114 Participants | 246 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 72 / 301 | 77 / 295 |
| serious Total, serious adverse events | 2 / 301 | 5 / 295 |
Outcome results
Primary
Average Eye IOP at Week 12
Average Eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported. Baseline data are included for reference only.
Time frame: Baseline, Week 12
Population: Intent to Treat Population: all randomized patients.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bimatoprost 0.03% Formulation B Ophthalmic Solution | Average Eye IOP at Week 12 | Baseline Hour 0 | 24.53 Millimeters of Mercury (mmHg) | Standard Deviation 2.196 |
| Bimatoprost 0.03% Formulation B Ophthalmic Solution | Average Eye IOP at Week 12 | Baseline Hour 2 | 23.30 Millimeters of Mercury (mmHg) | Standard Deviation 2.848 |
| Bimatoprost 0.03% Formulation B Ophthalmic Solution | Average Eye IOP at Week 12 | Baseline Hour 8 | 22.31 Millimeters of Mercury (mmHg) | Standard Deviation 2.974 |
| Bimatoprost 0.03% Formulation B Ophthalmic Solution | Average Eye IOP at Week 12 | Week 12 Hour 0 | 17.25 Millimeters of Mercury (mmHg) | Standard Deviation 2.804 |
| Bimatoprost 0.03% Formulation B Ophthalmic Solution | Average Eye IOP at Week 12 | Week 12 Hour 2 | 16.51 Millimeters of Mercury (mmHg) | Standard Deviation 2.9 |
| Bimatoprost 0.03% Formulation B Ophthalmic Solution | Average Eye IOP at Week 12 | Week 12 Hour 8 | 16.64 Millimeters of Mercury (mmHg) | Standard Deviation 2.82 |
| Bimatoprost 0.03% Ophthalmic Solution | Average Eye IOP at Week 12 | Week 12 Hour 2 | 16.55 Millimeters of Mercury (mmHg) | Standard Deviation 2.863 |
| Bimatoprost 0.03% Ophthalmic Solution | Average Eye IOP at Week 12 | Baseline Hour 0 | 24.46 Millimeters of Mercury (mmHg) | Standard Deviation 2.019 |
| Bimatoprost 0.03% Ophthalmic Solution | Average Eye IOP at Week 12 | Week 12 Hour 0 | 16.96 Millimeters of Mercury (mmHg) | Standard Deviation 2.886 |
| Bimatoprost 0.03% Ophthalmic Solution | Average Eye IOP at Week 12 | Baseline Hour 2 | 23.26 Millimeters of Mercury (mmHg) | Standard Deviation 2.613 |
| Bimatoprost 0.03% Ophthalmic Solution | Average Eye IOP at Week 12 | Week 12 Hour 8 | 16.59 Millimeters of Mercury (mmHg) | Standard Deviation 2.735 |
| Bimatoprost 0.03% Ophthalmic Solution | Average Eye IOP at Week 12 | Baseline Hour 8 | 22.29 Millimeters of Mercury (mmHg) | Standard Deviation 3.11 |
Primary
Average Eye IOP at Week 2
Average Eye IOP at Week 2 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported.
Time frame: Week 2
Population: Intent to Treat Population: all randomized patients.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bimatoprost 0.03% Formulation B Ophthalmic Solution | Average Eye IOP at Week 2 | Week 2 Hour 0 | 17.40 Millimeters of Mercury (mmHg) | Standard Deviation 2.732 |
| Bimatoprost 0.03% Formulation B Ophthalmic Solution | Average Eye IOP at Week 2 | Week 2 Hour 2 | 16.68 Millimeters of Mercury (mmHg) | Standard Deviation 2.759 |
| Bimatoprost 0.03% Formulation B Ophthalmic Solution | Average Eye IOP at Week 2 | Week 2 Hour 8 | 16.61 Millimeters of Mercury (mmHg) | Standard Deviation 2.766 |
| Bimatoprost 0.03% Ophthalmic Solution | Average Eye IOP at Week 2 | Week 2 Hour 0 | 17.14 Millimeters of Mercury (mmHg) | Standard Deviation 2.677 |
| Bimatoprost 0.03% Ophthalmic Solution | Average Eye IOP at Week 2 | Week 2 Hour 2 | 16.43 Millimeters of Mercury (mmHg) | Standard Deviation 2.581 |
| Bimatoprost 0.03% Ophthalmic Solution | Average Eye IOP at Week 2 | Week 2 Hour 8 | 16.39 Millimeters of Mercury (mmHg) | Standard Deviation 2.795 |
Primary
Average Eye IOP at Week 6
Average Eye IOP at Week 6 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported.
Time frame: Week 6
Population: Intent to Treat Population: all randomized patients.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bimatoprost 0.03% Formulation B Ophthalmic Solution | Average Eye IOP at Week 6 | Week 6 Hour 0 | 17.16 Millimeters of Mercury (mmHg) | Standard Deviation 2.967 |
| Bimatoprost 0.03% Formulation B Ophthalmic Solution | Average Eye IOP at Week 6 | Week 6 Hour 2 | 16.52 Millimeters of Mercury (mmHg) | Standard Deviation 2.855 |
| Bimatoprost 0.03% Formulation B Ophthalmic Solution | Average Eye IOP at Week 6 | Week 6 Hour 8 | 16.56 Millimeters of Mercury (mmHg) | Standard Deviation 2.838 |
| Bimatoprost 0.03% Ophthalmic Solution | Average Eye IOP at Week 6 | Week 6 Hour 0 | 17.08 Millimeters of Mercury (mmHg) | Standard Deviation 2.957 |
| Bimatoprost 0.03% Ophthalmic Solution | Average Eye IOP at Week 6 | Week 6 Hour 2 | 16.45 Millimeters of Mercury (mmHg) | Standard Deviation 2.766 |
| Bimatoprost 0.03% Ophthalmic Solution | Average Eye IOP at Week 6 | Week 6 Hour 8 | 16.32 Millimeters of Mercury (mmHg) | Standard Deviation 2.702 |
Primary
Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12
Change from baseline in worse eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements in the worse eye were evaluated at hours 0, 2, and 8. A negative number change from baseline indicated a reduction in IOP, and a positive number change from baseline indicated an increase in IOP.
Time frame: Baseline, Week 12
Population: Per Protocol Population: All randomized patients 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 0.03% Formulation B Ophthalmic Solution | Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12 | Baseline Hour 0 | 24.90 Millimeters of Mercury (mmHg) | Standard Deviation 2.364 |
| Bimatoprost 0.03% Formulation B Ophthalmic Solution | Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12 | Baseline Hour 2 | 23.79 Millimeters of Mercury (mmHg) | Standard Deviation 2.992 |
| Bimatoprost 0.03% Formulation B Ophthalmic Solution | Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12 | Baseline Hour 8 | 22.81 Millimeters of Mercury (mmHg) | Standard Deviation 3.168 |
| Bimatoprost 0.03% Formulation B Ophthalmic Solution | Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12 | Change from Baseline Hour 0 at Week 12 | -7.49 Millimeters of Mercury (mmHg) | Standard Deviation 2.9 |
| Bimatoprost 0.03% Formulation B Ophthalmic Solution | Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12 | Change from Baseline Hour 2 at Week 12 | -7.06 Millimeters of Mercury (mmHg) | Standard Deviation 3.333 |
| Bimatoprost 0.03% Formulation B Ophthalmic Solution | Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12 | Change from Baseline Hour 8 at Week 12 | -5.93 Millimeters of Mercury (mmHg) | Standard Deviation 3.432 |
| Bimatoprost 0.03% Ophthalmic Solution | Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12 | Change from Baseline Hour 2 at Week 12 | -7.11 Millimeters of Mercury (mmHg) | Standard Deviation 3.192 |
| Bimatoprost 0.03% Ophthalmic Solution | Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12 | Baseline Hour 0 | 24.86 Millimeters of Mercury (mmHg) | Standard Deviation 2.161 |
| Bimatoprost 0.03% Ophthalmic Solution | Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12 | Change from Baseline Hour 0 at Week 12 | -7.77 Millimeters of Mercury (mmHg) | Standard Deviation 3.029 |
| Bimatoprost 0.03% Ophthalmic Solution | Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12 | Baseline Hour 2 | 23.78 Millimeters of Mercury (mmHg) | Standard Deviation 2.753 |
| Bimatoprost 0.03% Ophthalmic Solution | Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12 | Change from Baseline Hour 8 at Week 12 | -6.06 Millimeters of Mercury (mmHg) | Standard Deviation 3.602 |
| Bimatoprost 0.03% Ophthalmic Solution | Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12 | Baseline Hour 8 | 22.80 Millimeters of Mercury (mmHg) | Standard Deviation 3.301 |