Open-Angle Glaucoma, Ocular Hypertension
Conditions
Brief summary
This study will evaluate the safety and efficacy of new ophthalmic formulations of bimatoprost in patients with open angle glaucoma and ocular hypertension. At least 3 dose strengths will be evaluated based on internal data review of each cohort. The study was planned to be conducted in 2 stages. Stage 1 was an open-label and Stage 2 was planned to be masked; however only Stage 1 was conducted.
Interventions
DRUGbimatoprost 20 µg generation 2
Single dose of bimatoprost ophthalmic administered in the study eye on Day 1.
DRUGbimatoprost 15 µg generation 2
Single dose of bimatoprost ophthalmic administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).
DRUGbimatoprost 10 µg generation 2
Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).
DRUGbimatoprost 6 µg generation 2
Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).
DRUGbimatoprost 15 µg generation 1
Single dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1.
DRUGbimatoprost 10 µg generation 1
Single dose of bimatoprost ophthalmic 10 µg generation 1 administered in the study eye on Day 1.
One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of open angle glaucoma or ocular hypertension
Exclusion criteria
* Uncontrolled medical conditions * Anticipated wearing of contact lenses during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye | Baseline, Month 24 | IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time-Matched Intraocular Pressure (IOP) in the Study Eye | Baseline to Month 6 | IOP is a measurement of the fluid pressure inside the study eye. |
| Mean Diurnal IOP in the Study Eye | Baseline, Month 6 | IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0, 2, 4, 6, and 8 and averaged to determine the mean diurnal IOP. |
| Time to Rescue Treatment or Re-Treatment in the Study Eye | 24 Months | Time to rescue treatment or the second treatment in the generation 2 groups is defined as the time between the first treatment and the second treatment in the study eye. |
Countries
Australia, Belgium, Brazil, Canada, Germany, Israel, Philippines, Singapore, Spain, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bimatoprost 20 µg Generation 2, Bimatoprost 0.03% Single dose of bimatoprost ophthalmic 20 µg generation 2 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. | 15 |
| Bimatoprost 15 µg Generation 2, Bimatoprost 0.03% Single dose of bimatoprost ophthalmic 15 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. | 21 |
| Bimatoprost 10 µg Generation 2, Bimatoprost 0.03% Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. | 21 |
| Bimatoprost 6 µg Generation 2, Bimatoprost 0.03% Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. | 18 |
| Bimatoprost 15 µg Generation 1, Bimatoprost 0.03% Single dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. | 11 |
| Bimatoprost 10 µg Generation 1, Bimatoprost 0.03% Single dose of bimatoprost ophthalmic 10 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. | 23 |
| Total | 109 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 1 | 0 | 1 | 0 |
| Overall Study | Lack of Efficacy | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Other Reasons | 1 | 1 | 2 | 1 | 0 | 0 |
| Overall Study | Personal Reasons | 0 | 2 | 0 | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Total | Bimatoprost 20 µg Generation 2, Bimatoprost 0.03% | Bimatoprost 15 µg Generation 2, Bimatoprost 0.03% | Bimatoprost 10 µg Generation 2, Bimatoprost 0.03% | Bimatoprost 6 µg Generation 2, Bimatoprost 0.03% | Bimatoprost 15 µg Generation 1, Bimatoprost 0.03% | Bimatoprost 10 µg Generation 1, Bimatoprost 0.03% |
|---|---|---|---|---|---|---|---|
| Age, Customized 45-65 years | 49 Participants | 6 Participants | 9 Participants | 12 Participants | 9 Participants | 3 Participants | 10 Participants |
| Age, Customized <45 years | 6 Participants | 1 Participants | 2 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants |
| Age, Customized >65 years | 54 Participants | 8 Participants | 10 Participants | 9 Participants | 7 Participants | 8 Participants | 12 Participants |
| Sex: Female, Male Female | 56 Participants | 7 Participants | 10 Participants | 9 Participants | 12 Participants | 5 Participants | 13 Participants |
| Sex: Female, Male Male | 53 Participants | 8 Participants | 11 Participants | 12 Participants | 6 Participants | 6 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 12 / 15 | 16 / 21 | 17 / 21 | 15 / 18 | 8 / 11 | 21 / 23 |
| serious Total, serious adverse events | 0 / 15 | 3 / 21 | 6 / 21 | 4 / 18 | 3 / 11 | 3 / 23 |
Outcome results
Primary
Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye
IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Time frame: Baseline, Month 24
Population: Modified Intent-to-Treat: all treated patients with at least 1 IOP measurement at baseline and at least 1 postbaseline IOP measurement through Week 16. Excluding IOP assessments after rescue or retreatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bimatoprost 20 µg Generation 2, Bimatoprost 0.03% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye | Month 24, Hour 0 | -5.75 Millimeters of Mercury (mmHg) | Standard Deviation 4.33 |
| Bimatoprost 20 µg Generation 2, Bimatoprost 0.03% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye | Month 6, Hour 0 | -5.65 Millimeters of Mercury (mmHg) | Standard Deviation 3.652 |
| Bimatoprost 20 µg Generation 2, Bimatoprost 0.03% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye | Week 12, Hour 0 | -7.92 Millimeters of Mercury (mmHg) | Standard Deviation 2.557 |
| Bimatoprost 20 µg Generation 2, Bimatoprost 0.03% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye | Baseline Hour 0, | 26.57 Millimeters of Mercury (mmHg) | Standard Deviation 4.144 |
| Bimatoprost 20 µg Generation 2, Bimatoprost 0.03% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye | Month 18, Hour 0 | -6.00 Millimeters of Mercury (mmHg) | Standard Deviation 3.464 |
| Bimatoprost 20 µg Generation 2, Bimatoprost 0.03% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye | Month 12, Hour 0 | -9.00 Millimeters of Mercury (mmHg) | Standard Deviation 2.387 |
| Bimatoprost 20 µg Generation 2, Bimatoprost 0.03% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye | Week 4, Hour 0 | -8.83 Millimeters of Mercury (mmHg) | Standard Deviation 3.75 |
| Bimatoprost 15 µg Generation 2, Bimatoprost 0.03% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye | Month 12, Hour 0 | -5.64 Millimeters of Mercury (mmHg) | Standard Deviation 2.824 |
| Bimatoprost 15 µg Generation 2, Bimatoprost 0.03% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye | Week 4, Hour 0 | -7.80 Millimeters of Mercury (mmHg) | Standard Deviation 2.613 |
| Bimatoprost 15 µg Generation 2, Bimatoprost 0.03% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye | Month 24, Hour 0 | -7.30 Millimeters of Mercury (mmHg) | Standard Deviation 2.019 |
| Bimatoprost 15 µg Generation 2, Bimatoprost 0.03% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye | Month 6, Hour 0 | -6.50 Millimeters of Mercury (mmHg) | Standard Deviation 2.646 |
| Bimatoprost 15 µg Generation 2, Bimatoprost 0.03% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye | Week 12, Hour 0 | -7.02 Millimeters of Mercury (mmHg) | Standard Deviation 3.215 |
| Bimatoprost 15 µg Generation 2, Bimatoprost 0.03% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye | Month 18, Hour 0 | -6.92 Millimeters of Mercury (mmHg) | Standard Deviation 2.558 |
| Bimatoprost 15 µg Generation 2, Bimatoprost 0.03% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye | Baseline Hour 0, | 25.14 Millimeters of Mercury (mmHg) | Standard Deviation 2.967 |
| Bimatoprost 10 µg Generation 2, Bimatoprost 0.03% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye | Month 12, Hour 0 | -6.00 Millimeters of Mercury (mmHg) | Standard Deviation 2.881 |
| Bimatoprost 10 µg Generation 2, Bimatoprost 0.03% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye | Month 18, Hour 0 | -7.70 Millimeters of Mercury (mmHg) | Standard Deviation 3.493 |
| Bimatoprost 10 µg Generation 2, Bimatoprost 0.03% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye | Baseline Hour 0, | 24.48 Millimeters of Mercury (mmHg) | Standard Deviation 2.112 |
| Bimatoprost 10 µg Generation 2, Bimatoprost 0.03% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye | Month 24, Hour 0 | -7.40 Millimeters of Mercury (mmHg) | Standard Deviation 1.557 |
| Bimatoprost 10 µg Generation 2, Bimatoprost 0.03% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye | Week 4, Hour 0 | -7.18 Millimeters of Mercury (mmHg) | Standard Deviation 3.25 |
| Bimatoprost 10 µg Generation 2, Bimatoprost 0.03% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye | Week 12, Hour 0 | -6.82 Millimeters of Mercury (mmHg) | Standard Deviation 3.024 |
| Bimatoprost 10 µg Generation 2, Bimatoprost 0.03% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye | Month 6, Hour 0 | -5.38 Millimeters of Mercury (mmHg) | Standard Deviation 3.015 |
| Bimatoprost 6 µg Generation 2, Bimatoprost 0.03% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye | Week 4, Hour 0 | -7.09 Millimeters of Mercury (mmHg) | Standard Deviation 2.697 |
| Bimatoprost 6 µg Generation 2, Bimatoprost 0.03% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye | Month 12, Hour 0 | -5.38 Millimeters of Mercury (mmHg) | Standard Deviation 3.091 |
| Bimatoprost 6 µg Generation 2, Bimatoprost 0.03% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye | Month 6, Hour 0 | -6.81 Millimeters of Mercury (mmHg) | Standard Deviation 2.529 |
| Bimatoprost 6 µg Generation 2, Bimatoprost 0.03% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye | Month 24, Hour 0 | -5.70 Millimeters of Mercury (mmHg) | Standard Deviation 2.197 |
| Bimatoprost 6 µg Generation 2, Bimatoprost 0.03% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye | Month 18, Hour 0 | -6.93 Millimeters of Mercury (mmHg) | Standard Deviation 2.335 |
| Bimatoprost 6 µg Generation 2, Bimatoprost 0.03% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye | Baseline Hour 0, | 25.14 Millimeters of Mercury (mmHg) | Standard Deviation 3.609 |
| Bimatoprost 6 µg Generation 2, Bimatoprost 0.03% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye | Week 12, Hour 0 | -6.53 Millimeters of Mercury (mmHg) | Standard Deviation 4.091 |
| Bimatoprost 15 μg Generation 1, Bimatoprost 0.03% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye | Week 12, Hour 0 | -5.95 Millimeters of Mercury (mmHg) | Standard Deviation 3.546 |
| Bimatoprost 15 μg Generation 1, Bimatoprost 0.03% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye | Month 12, Hour 0 | -5.80 Millimeters of Mercury (mmHg) | Standard Deviation 4.251 |
| Bimatoprost 15 μg Generation 1, Bimatoprost 0.03% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye | Baseline Hour 0, | 23.73 Millimeters of Mercury (mmHg) | Standard Deviation 1.664 |
| Bimatoprost 15 μg Generation 1, Bimatoprost 0.03% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye | Week 4, Hour 0 | -5.50 Millimeters of Mercury (mmHg) | Standard Deviation 3.507 |
| Bimatoprost 15 μg Generation 1, Bimatoprost 0.03% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye | Month 6, Hour 0 | -3.94 Millimeters of Mercury (mmHg) | Standard Deviation 4.17 |
| Bimatoprost 15 μg Generation 1, Bimatoprost 0.03% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye | Month 18, Hour 0 | -4.25 Millimeters of Mercury (mmHg) | Standard Deviation 0.354 |
| Bimatoprost 15 μg Generation 1, Bimatoprost 0.03% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye | Month 24, Hour 0 | -8.50 Millimeters of Mercury (mmHg) | — |
| Bimatoprost 10 μg Generation 1, Bimatoprost 0.03% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye | Month 18, Hour 0 | -9.75 Millimeters of Mercury (mmHg) | Standard Deviation 3.182 |
| Bimatoprost 10 μg Generation 1, Bimatoprost 0.03% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye | Week 12, Hour 0 | -7.00 Millimeters of Mercury (mmHg) | Standard Deviation 2.899 |
| Bimatoprost 10 μg Generation 1, Bimatoprost 0.03% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye | Week 4, Hour 0 | -7.33 Millimeters of Mercury (mmHg) | Standard Deviation 3.006 |
| Bimatoprost 10 μg Generation 1, Bimatoprost 0.03% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye | Baseline Hour 0, | 24.22 Millimeters of Mercury (mmHg) | Standard Deviation 2.104 |
| Bimatoprost 10 μg Generation 1, Bimatoprost 0.03% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye | Month 12, Hour 0 | -5.71 Millimeters of Mercury (mmHg) | Standard Deviation 2.138 |
| Bimatoprost 10 μg Generation 1, Bimatoprost 0.03% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye | Month 6, Hour 0 | -5.40 Millimeters of Mercury (mmHg) | Standard Deviation 3.106 |
| Bimatoprost 10 μg Generation 1, Bimatoprost 0.03% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye | Month 24, Hour 0 | -5.50 Millimeters of Mercury (mmHg) | — |
Secondary
Mean Diurnal IOP in the Study Eye
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0, 2, 4, 6, and 8 and averaged to determine the mean diurnal IOP.
Time frame: Baseline, Month 6
Population: Modified Intent-to-Treat: all treated patients with at least 1 IOP measurement at baseline and at least 1 postbaseline IOP measurement through Week 16. Including IOP assessments after rescue or retreatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bimatoprost 20 µg Generation 2, Bimatoprost 0.03% | Mean Diurnal IOP in the Study Eye | Week 12 | 17.34 mmHg | Standard Deviation 3.608 |
| Bimatoprost 20 µg Generation 2, Bimatoprost 0.03% | Mean Diurnal IOP in the Study Eye | Week 4 | 17.10 mmHg | Standard Deviation 4.584 |
| Bimatoprost 20 µg Generation 2, Bimatoprost 0.03% | Mean Diurnal IOP in the Study Eye | Baseline | 23.38 mmHg | Standard Deviation 3.967 |
| Bimatoprost 20 µg Generation 2, Bimatoprost 0.03% | Mean Diurnal IOP in the Study Eye | Month 6 | 19.79 mmHg | Standard Deviation 4.498 |
| Bimatoprost 15 µg Generation 2, Bimatoprost 0.03% | Mean Diurnal IOP in the Study Eye | Month 6 | 18.51 mmHg | Standard Deviation 3.539 |
| Bimatoprost 15 µg Generation 2, Bimatoprost 0.03% | Mean Diurnal IOP in the Study Eye | Week 12 | 18.22 mmHg | Standard Deviation 3.294 |
| Bimatoprost 15 µg Generation 2, Bimatoprost 0.03% | Mean Diurnal IOP in the Study Eye | Baseline | 23.74 mmHg | Standard Deviation 3.411 |
| Bimatoprost 15 µg Generation 2, Bimatoprost 0.03% | Mean Diurnal IOP in the Study Eye | Week 4 | 16.59 mmHg | Standard Deviation 1.884 |
| Bimatoprost 10 µg Generation 2, Bimatoprost 0.03% | Mean Diurnal IOP in the Study Eye | Baseline | 23.02 mmHg | Standard Deviation 2.011 |
| Bimatoprost 10 µg Generation 2, Bimatoprost 0.03% | Mean Diurnal IOP in the Study Eye | Week 4 | 16.40 mmHg | Standard Deviation 2.529 |
| Bimatoprost 10 µg Generation 2, Bimatoprost 0.03% | Mean Diurnal IOP in the Study Eye | Month 6 | 18.94 mmHg | Standard Deviation 2.879 |
| Bimatoprost 10 µg Generation 2, Bimatoprost 0.03% | Mean Diurnal IOP in the Study Eye | Week 12 | 17.33 mmHg | Standard Deviation 2.274 |
| Bimatoprost 6 µg Generation 2, Bimatoprost 0.03% | Mean Diurnal IOP in the Study Eye | Week 12 | 17.29 mmHg | Standard Deviation 3.199 |
| Bimatoprost 6 µg Generation 2, Bimatoprost 0.03% | Mean Diurnal IOP in the Study Eye | Baseline | 23.54 mmHg | Standard Deviation 5.121 |
| Bimatoprost 6 µg Generation 2, Bimatoprost 0.03% | Mean Diurnal IOP in the Study Eye | Week 4 | 17.35 mmHg | Standard Deviation 5.81 |
| Bimatoprost 6 µg Generation 2, Bimatoprost 0.03% | Mean Diurnal IOP in the Study Eye | Month 6 | 16.71 mmHg | Standard Deviation 1.879 |
| Bimatoprost 15 μg Generation 1, Bimatoprost 0.03% | Mean Diurnal IOP in the Study Eye | Baseline | 20.84 mmHg | Standard Deviation 2.123 |
| Bimatoprost 15 μg Generation 1, Bimatoprost 0.03% | Mean Diurnal IOP in the Study Eye | Week 12 | 17.12 mmHg | Standard Deviation 2.211 |
| Bimatoprost 15 μg Generation 1, Bimatoprost 0.03% | Mean Diurnal IOP in the Study Eye | Month 6 | 18.13 mmHg | Standard Deviation 3.08 |
| Bimatoprost 15 μg Generation 1, Bimatoprost 0.03% | Mean Diurnal IOP in the Study Eye | Week 4 | 17.89 mmHg | Standard Deviation 2.038 |
| Bimatoprost 10 μg Generation 1, Bimatoprost 0.03% | Mean Diurnal IOP in the Study Eye | Week 4 | 16.88 mmHg | Standard Deviation 3.782 |
| Bimatoprost 10 μg Generation 1, Bimatoprost 0.03% | Mean Diurnal IOP in the Study Eye | Baseline | 22.09 mmHg | Standard Deviation 2.521 |
| Bimatoprost 10 μg Generation 1, Bimatoprost 0.03% | Mean Diurnal IOP in the Study Eye | Week 12 | 17.06 mmHg | Standard Deviation 2.604 |
| Bimatoprost 10 μg Generation 1, Bimatoprost 0.03% | Mean Diurnal IOP in the Study Eye | Month 6 | 18.55 mmHg | Standard Deviation 3.632 |
Secondary
Time-Matched Intraocular Pressure (IOP) in the Study Eye
IOP is a measurement of the fluid pressure inside the study eye.
Time frame: Baseline to Month 6
Population: Modified Intent-to-Treat: all treated patients with at least 1 IOP measurement at baseline and at least 1 postbaseline IOP measurement through Week 16. Excluding IOP assessments after rescue or retreatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bimatoprost 20 µg Generation 2, Bimatoprost 0.03% | Time-Matched Intraocular Pressure (IOP) in the Study Eye | Month 6, Hour 0 | 19.10 Millimeters of Mercury (mmHg) | Standard Deviation 3.843 |
| Bimatoprost 20 µg Generation 2, Bimatoprost 0.03% | Time-Matched Intraocular Pressure (IOP) in the Study Eye | Week 12, Hour 0 | 17.71 Millimeters of Mercury (mmHg) | Standard Deviation 2.996 |
| Bimatoprost 20 µg Generation 2, Bimatoprost 0.03% | Time-Matched Intraocular Pressure (IOP) in the Study Eye | Baseline, Hour 0 | 26.57 Millimeters of Mercury (mmHg) | Standard Deviation 4.144 |
| Bimatoprost 20 µg Generation 2, Bimatoprost 0.03% | Time-Matched Intraocular Pressure (IOP) in the Study Eye | Week 4, Hour 0 | 17.73 Millimeters of Mercury (mmHg) | Standard Deviation 3.982 |
| Bimatoprost 15 µg Generation 2, Bimatoprost 0.03% | Time-Matched Intraocular Pressure (IOP) in the Study Eye | Week 12, Hour 0 | 18.12 Millimeters of Mercury (mmHg) | Standard Deviation 3.626 |
| Bimatoprost 15 µg Generation 2, Bimatoprost 0.03% | Time-Matched Intraocular Pressure (IOP) in the Study Eye | Baseline, Hour 0 | 25.14 Millimeters of Mercury (mmHg) | Standard Deviation 2.967 |
| Bimatoprost 15 µg Generation 2, Bimatoprost 0.03% | Time-Matched Intraocular Pressure (IOP) in the Study Eye | Month 6, Hour 0 | 17.90 Millimeters of Mercury (mmHg) | Standard Deviation 3.785 |
| Bimatoprost 15 µg Generation 2, Bimatoprost 0.03% | Time-Matched Intraocular Pressure (IOP) in the Study Eye | Week 4, Hour 0 | 17.45 Millimeters of Mercury (mmHg) | Standard Deviation 2.032 |
| Bimatoprost 10 µg Generation 2, Bimatoprost 0.03% | Time-Matched Intraocular Pressure (IOP) in the Study Eye | Month 6, Hour 0 | 19.35 Millimeters of Mercury (mmHg) | Standard Deviation 2.536 |
| Bimatoprost 10 µg Generation 2, Bimatoprost 0.03% | Time-Matched Intraocular Pressure (IOP) in the Study Eye | Baseline, Hour 0 | 24.48 Millimeters of Mercury (mmHg) | Standard Deviation 2.112 |
| Bimatoprost 10 µg Generation 2, Bimatoprost 0.03% | Time-Matched Intraocular Pressure (IOP) in the Study Eye | Week 4, Hour 0 | 17.55 Millimeters of Mercury (mmHg) | Standard Deviation 3.166 |
| Bimatoprost 10 µg Generation 2, Bimatoprost 0.03% | Time-Matched Intraocular Pressure (IOP) in the Study Eye | Week 12, Hour 0 | 17.61 Millimeters of Mercury (mmHg) | Standard Deviation 2.289 |
| Bimatoprost 6 µg Generation 2, Bimatoprost 0.03% | Time-Matched Intraocular Pressure (IOP) in the Study Eye | Week 4, Hour 0 | 17.53 Millimeters of Mercury (mmHg) | Standard Deviation 2.661 |
| Bimatoprost 6 µg Generation 2, Bimatoprost 0.03% | Time-Matched Intraocular Pressure (IOP) in the Study Eye | Baseline, Hour 0 | 25.14 Millimeters of Mercury (mmHg) | Standard Deviation 3.609 |
| Bimatoprost 6 µg Generation 2, Bimatoprost 0.03% | Time-Matched Intraocular Pressure (IOP) in the Study Eye | Month 6, Hour 0 | 17.35 Millimeters of Mercury (mmHg) | Standard Deviation 2.135 |
| Bimatoprost 6 µg Generation 2, Bimatoprost 0.03% | Time-Matched Intraocular Pressure (IOP) in the Study Eye | Week 12, Hour 0 | 18.03 Millimeters of Mercury (mmHg) | Standard Deviation 3.659 |
| Bimatoprost 15 μg Generation 1, Bimatoprost 0.03% | Time-Matched Intraocular Pressure (IOP) in the Study Eye | Week 4, Hour 0 | 18.23 Millimeters of Mercury (mmHg) | Standard Deviation 4.315 |
| Bimatoprost 15 μg Generation 1, Bimatoprost 0.03% | Time-Matched Intraocular Pressure (IOP) in the Study Eye | Baseline, Hour 0 | 23.73 Millimeters of Mercury (mmHg) | Standard Deviation 1.664 |
| Bimatoprost 15 μg Generation 1, Bimatoprost 0.03% | Time-Matched Intraocular Pressure (IOP) in the Study Eye | Week 12, Hour 0 | 17.77 Millimeters of Mercury (mmHg) | Standard Deviation 2.97 |
| Bimatoprost 15 μg Generation 1, Bimatoprost 0.03% | Time-Matched Intraocular Pressure (IOP) in the Study Eye | Month 6, Hour 0 | 19.44 Millimeters of Mercury (mmHg) | Standard Deviation 3.61 |
| Bimatoprost 10 μg Generation 1, Bimatoprost 0.03% | Time-Matched Intraocular Pressure (IOP) in the Study Eye | Month 6, Hour 0 | 18.80 Millimeters of Mercury (mmHg) | Standard Deviation 3.282 |
| Bimatoprost 10 μg Generation 1, Bimatoprost 0.03% | Time-Matched Intraocular Pressure (IOP) in the Study Eye | Baseline, Hour 0 | 24.22 Millimeters of Mercury (mmHg) | Standard Deviation 2.104 |
| Bimatoprost 10 μg Generation 1, Bimatoprost 0.03% | Time-Matched Intraocular Pressure (IOP) in the Study Eye | Week 4, Hour 0 | 17.00 Millimeters of Mercury (mmHg) | Standard Deviation 2.748 |
| Bimatoprost 10 μg Generation 1, Bimatoprost 0.03% | Time-Matched Intraocular Pressure (IOP) in the Study Eye | Week 12, Hour 0 | 17.23 Millimeters of Mercury (mmHg) | Standard Deviation 2.443 |
Secondary
Time to Rescue Treatment or Re-Treatment in the Study Eye
Time to rescue treatment or the second treatment in the generation 2 groups is defined as the time between the first treatment and the second treatment in the study eye.
Time frame: 24 Months
Population: Modified Intent-to-Treat: all treated patients with at least 1 IOP measurement at baseline and at least 1 postbaseline IOP measurement through Week 16
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bimatoprost 20 µg Generation 2, Bimatoprost 0.03% | Time to Rescue Treatment or Re-Treatment in the Study Eye | 328 Days |
| Bimatoprost 15 µg Generation 2, Bimatoprost 0.03% | Time to Rescue Treatment or Re-Treatment in the Study Eye | 265 Days |
| Bimatoprost 10 µg Generation 2, Bimatoprost 0.03% | Time to Rescue Treatment or Re-Treatment in the Study Eye | 273 Days |
| Bimatoprost 6 µg Generation 2, Bimatoprost 0.03% | Time to Rescue Treatment or Re-Treatment in the Study Eye | 391.5 Days |
| Bimatoprost 15 μg Generation 1, Bimatoprost 0.03% | Time to Rescue Treatment or Re-Treatment in the Study Eye | 411 Days |
| Bimatoprost 10 μg Generation 1, Bimatoprost 0.03% | Time to Rescue Treatment or Re-Treatment in the Study Eye | 237 Days |