Glaucoma, Open-Angle, Ocular Hypertension
Conditions
Brief summary
This study will evaluate the efficacy and safety of bimatoprost SR in participants with open-angle glaucoma or ocular hypertension. The study includes a 12-month treatment period with an 8-month extended follow-up.
Interventions
Sham administered on Day 1, Week 16, and Week 32.
Timolol vehicle administered once in the morning and once in the evening for up to 20 months.
Timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
DRUGBimatoprost SR
Bimatoprost SR administered in the study eye on Day 1, Week 16, and Week 32.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-Diagnosis of either open-angle glaucoma or ocular hypertension in each eye and both eyes require IOP-lowering treatment.
Exclusion criteria
* Previous enrollment in another Allergan Bimatoprost SR Study. * Eye surgery (including cataract surgery) and/or any eye laser surgery within the past 6 months in the study eye * Anticipated need for laser eye surgery in either eye within the first 52 weeks of the study duration * History of glaucoma surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IOP in the Study Eye at Week 12 (Hour 2) | Week 12 (Hour 2) | IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses. |
| Change From Baseline in IOP in the Study Eye at Week 12 (Hours 0 and 2) | Baseline (Hours 0 and 2) to Week 12 (Hours 0 and 2) | IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. A mixed-effects model with repeated measures (MMRM) was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening. |
| IOP in the Study Eye at Week 2 (Hour 0) | Week 2 (Hour 0) | IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses. |
| IOP in the Study Eye at Week 2 (Hour 2) | Week 2 (Hour 2) | IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses. |
| IOP in the Study Eye at Week 6 (Hour 0) | Week 6 (Hour 0) | IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses. |
| IOP in the Study Eye at Week 6 (Hour 2) | Week 6 (Hour 2) | IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses. |
| IOP in the Study Eye at Week 12 (Hour 0) | Week 12 (Hour 0) | IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in IOP in the Study Eye | Baseline (Hours 0 and 2) to Weeks 2 and 6 (Hours 0 and 2) | IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening. |
Countries
Australia, Austria, Belgium, Brazil, Denmark, Hong Kong, Hungary, Israel, Peru, Philippines, Poland, Spain, Taiwan, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bimatoprost SR 15 μg Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months. | 198 |
| Bimatoprost SR 10 μg Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months. | 198 |
| Timolol 0.5%: Comparator Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months. | 198 |
| Total | 594 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Treatment Period 1 | Adverse Event | 9 | 2 | 0 |
| Treatment Period 1 | Lack of Efficacy | 0 | 0 | 2 |
| Treatment Period 1 | Lost to Follow-up | 1 | 0 | 2 |
| Treatment Period 1 | Personal Reasons | 7 | 1 | 2 |
| Treatment Period 1 | Protocol Deviation | 0 | 0 | 1 |
| Treatment Period 1 | Randomized but not Treated | 5 | 1 | 1 |
| Treatment Period 2 | Adverse Event | 6 | 3 | 3 |
| Treatment Period 2 | Lack of Efficacy | 0 | 0 | 1 |
| Treatment Period 2 | Lost to Follow-up | 0 | 1 | 1 |
| Treatment Period 2 | Personal Reasons | 2 | 1 | 1 |
| Treatment Period 2 | Reason not Specified | 0 | 0 | 2 |
| Treatment Period 3 | Adverse Event | 4 | 3 | 3 |
| Treatment Period 3 | Lack of Efficacy | 0 | 1 | 0 |
| Treatment Period 3 | Lost to Follow-up | 1 | 2 | 2 |
| Treatment Period 3 | Personal Reasons | 4 | 3 | 2 |
| Treatment Period 3 | Reason not Specified | 2 | 1 | 3 |
Baseline characteristics
| Characteristic | Bimatoprost SR 10 μg | Bimatoprost SR 15 μg | Timolol 0.5%: Comparator | Total |
|---|---|---|---|---|
| Age, Continuous | 62.6 years STANDARD_DEVIATION 11.5 | 62.5 years STANDARD_DEVIATION 13 | 62.5 years STANDARD_DEVIATION 11 | 62.5 years STANDARD_DEVIATION 11.9 |
| Intraocular Pressure (IOP) Hour 0 | 24.64 mm Hg | 24.76 mm Hg | 24.63 mm Hg | 24.68 mm Hg |
| Intraocular Pressure (IOP) Hour 2 | 23.29 mm Hg | 23.56 mm Hg | 23.19 mm Hg | 23.35 mm Hg |
| Race/Ethnicity, Customized Asian | 17 Participants | 12 Participants | 16 Participants | 45 Participants |
| Race/Ethnicity, Customized Black or African American | 31 Participants | 30 Participants | 21 Participants | 82 Participants |
| Race/Ethnicity, Customized Hispanic | 23 Participants | 27 Participants | 25 Participants | 75 Participants |
| Race/Ethnicity, Customized Not Reported | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 4 Participants | 6 Participants | 5 Participants | 15 Participants |
| Race/Ethnicity, Customized White | 123 Participants | 122 Participants | 130 Participants | 375 Participants |
| Sex: Female, Male Female | 86 Participants | 96 Participants | 106 Participants | 288 Participants |
| Sex: Female, Male Male | 112 Participants | 102 Participants | 92 Participants | 306 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 193 | 1 / 197 | 1 / 197 |
| other Total, other adverse events | 143 / 193 | 138 / 197 | 105 / 197 |
| serious Total, serious adverse events | 31 / 193 | 25 / 197 | 18 / 197 |
Outcome results
Primary
Change From Baseline in IOP in the Study Eye at Week 12 (Hours 0 and 2)
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. A mixed-effects model with repeated measures (MMRM) was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Time frame: Baseline (Hours 0 and 2) to Week 12 (Hours 0 and 2)
Population: ITT population was defined as all randomized participants. Number analyzed is the number of participants with evaluable data at the given timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Bimatoprost SR 15 μg | Change From Baseline in IOP in the Study Eye at Week 12 (Hours 0 and 2) | Change from Baseline at Hour 0, Week 12 | -6.46 millimeters of mercury (mm Hg) | Standard Error 0.29 |
| Bimatoprost SR 15 μg | Change From Baseline in IOP in the Study Eye at Week 12 (Hours 0 and 2) | Change from Baseline at Hour 2, Week 12 | -7.18 millimeters of mercury (mm Hg) | Standard Error 0.26 |
| Bimatoprost SR 10 μg | Change From Baseline in IOP in the Study Eye at Week 12 (Hours 0 and 2) | Change from Baseline at Hour 0, Week 12 | -6.38 millimeters of mercury (mm Hg) | Standard Error 0.28 |
| Bimatoprost SR 10 μg | Change From Baseline in IOP in the Study Eye at Week 12 (Hours 0 and 2) | Change from Baseline at Hour 2, Week 12 | -6.69 millimeters of mercury (mm Hg) | Standard Error 0.25 |
| Timolol 0.5%: Comparator | Change From Baseline in IOP in the Study Eye at Week 12 (Hours 0 and 2) | Change from Baseline at Hour 0, Week 12 | -6.05 millimeters of mercury (mm Hg) | Standard Error 0.28 |
| Timolol 0.5%: Comparator | Change From Baseline in IOP in the Study Eye at Week 12 (Hours 0 and 2) | Change from Baseline at Hour 2, Week 12 | -6.48 millimeters of mercury (mm Hg) | Standard Error 0.25 |
Comparison: Change from Baseline Week 12, Hour 0: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Week 12).p-value: 0.29595% CI: [-1.17, 0.36]MMRM
Comparison: Change from Baseline Week 12, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Week 12).p-value: 0.390495% CI: [-1.09, 0.43]MMRM
Comparison: Change from Baseline Week 12, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Week 12).p-value: 0.046495% CI: [-1.4, -0.01]MMRM
Comparison: Change from Baseline Week 12, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Week 12).p-value: 0.538395% CI: [-0.9, 0.47]MMRM
Primary
IOP in the Study Eye at Week 12 (Hour 0)
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
Time frame: Week 12 (Hour 0)
Population: ITT population was defined as all randomized participants. Overall number of participants analyzed is the number of participants with data available for analyses.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Bimatoprost SR 15 μg | IOP in the Study Eye at Week 12 (Hour 0) | 17.53 mm Hg | Standard Error 0.29 |
| Bimatoprost SR 10 μg | IOP in the Study Eye at Week 12 (Hour 0) | 17.61 mm Hg | Standard Error 0.28 |
| Timolol 0.5%: Comparator | IOP in the Study Eye at Week 12 (Hour 0) | 17.94 mm Hg | Standard Error 0.28 |
Comparison: Week 12, Hour 0: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).p-value: 0.29595% CI: [-1.17, 0.36]MMRM
Comparison: Week 12, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).p-value: 0.390495% CI: [-1.09, 0.43]MMRM
Primary
IOP in the Study Eye at Week 12 (Hour 2)
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
Time frame: Week 12 (Hour 2)
Population: ITT population was defined as all randomized participants. Overall number of participants analyzed is the number of participants with data available for analyses.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Bimatoprost SR 15 μg | IOP in the Study Eye at Week 12 (Hour 2) | 16.81 mm Hg | Standard Error 0.26 |
| Bimatoprost SR 10 μg | IOP in the Study Eye at Week 12 (Hour 2) | 17.30 mm Hg | Standard Error 0.25 |
| Timolol 0.5%: Comparator | IOP in the Study Eye at Week 12 (Hour 2) | 17.51 mm Hg | Standard Error 0.25 |
Comparison: Week 12, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).p-value: 0.046495% CI: [-1.4, -0.01]MMRM
Comparison: Week 12, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).p-value: 0.538395% CI: [-0.9, 0.47]MMRM
Primary
IOP in the Study Eye at Week 2 (Hour 0)
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
Time frame: Week 2 (Hour 0)
Population: ITT population was defined as all randomized participants. Overall number of participants analyzed is the number of participants with data available for analyses.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Bimatoprost SR 15 μg | IOP in the Study Eye at Week 2 (Hour 0) | 16.82 mm Hg | Standard Error 0.25 |
| Bimatoprost SR 10 μg | IOP in the Study Eye at Week 2 (Hour 0) | 17.02 mm Hg | Standard Error 0.25 |
| Timolol 0.5%: Comparator | IOP in the Study Eye at Week 2 (Hour 0) | 17.83 mm Hg | Standard Error 0.25 |
Comparison: Week 2, Hour 0: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).p-value: 0.003395% CI: [-1.68, -0.34]MMRM
Comparison: Week 2, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).p-value: 0.018795% CI: [-1.47, -0.13]MMRM
Primary
IOP in the Study Eye at Week 2 (Hour 2)
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
Time frame: Week 2 (Hour 2)
Population: ITT population was defined as all randomized participants. Overall number of participants analyzed is the number of participants with data available for analyses.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Bimatoprost SR 15 μg | IOP in the Study Eye at Week 2 (Hour 2) | 16.48 mm Hg | Standard Error 0.22 |
| Bimatoprost SR 10 μg | IOP in the Study Eye at Week 2 (Hour 2) | 16.42 mm Hg | Standard Error 0.22 |
| Timolol 0.5%: Comparator | IOP in the Study Eye at Week 2 (Hour 2) | 17.33 mm Hg | Standard Error 0.22 |
Comparison: Week 2, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).p-value: 0.005795% CI: [-1.45, -0.25]MMRM
Comparison: Week 2, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).p-value: 0.003195% CI: [-1.5, -0.31]MMRM
Primary
IOP in the Study Eye at Week 6 (Hour 0)
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
Time frame: Week 6 (Hour 0)
Population: ITT population was defined as all randomized participants. Overall number of participants analyzed is the number of participants with data available for analyses.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Bimatoprost SR 15 μg | IOP in the Study Eye at Week 6 (Hour 0) | 17.08 mm Hg | Standard Error 0.24 |
| Bimatoprost SR 10 μg | IOP in the Study Eye at Week 6 (Hour 0) | 16.88 mm Hg | Standard Error 0.23 |
| Timolol 0.5%: Comparator | IOP in the Study Eye at Week 6 (Hour 0) | 17.71 mm Hg | Standard Error 0.24 |
Comparison: Week 6, Hour 0: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).p-value: 0.054795% CI: [-1.26, 0.01]MMRM
Comparison: Week 6, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).p-value: 0.010795% CI: [-1.46, -0.19]MMRM
Primary
IOP in the Study Eye at Week 6 (Hour 2)
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
Time frame: Week 6 (Hour 2)
Population: ITT population was defined as all randomized participants. Overall number of participants analyzed is the number of participants with data available for analyses.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Bimatoprost SR 15 μg | IOP in the Study Eye at Week 6 (Hour 2) | 16.62 mm Hg | Standard Error 0.23 |
| Bimatoprost SR 10 μg | IOP in the Study Eye at Week 6 (Hour 2) | 16.51 mm Hg | Standard Error 0.22 |
| Timolol 0.5%: Comparator | IOP in the Study Eye at Week 6 (Hour 2) | 17.16 mm Hg | Standard Error 0.23 |
Comparison: Week 6, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).p-value: 0.08695% CI: [-1.16, 0.08]MMRM
Comparison: Week 6, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).p-value: 0.036295% CI: [-1.27, -0.04]MMRM
Secondary
Change From Baseline in IOP in the Study Eye
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Time frame: Baseline (Hours 0 and 2) to Weeks 2 and 6 (Hours 0 and 2)
Population: ITT population was defined as all randomized participants. Number analyzed is the number of participants with evaluable data at the given timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Bimatoprost SR 15 μg | Change From Baseline in IOP in the Study Eye | Change from Baseline at Hour 0, Week 2 | -7.17 mm Hg | Standard Error 0.25 |
| Bimatoprost SR 15 μg | Change From Baseline in IOP in the Study Eye | Change from Baseline at Hour 2, Week 2 | -7.52 mm Hg | Standard Error 0.22 |
| Bimatoprost SR 15 μg | Change From Baseline in IOP in the Study Eye | Change from Baseline at Hour 0, Week 6 | -6.91 mm Hg | Standard Error 0.24 |
| Bimatoprost SR 15 μg | Change From Baseline in IOP in the Study Eye | Change from Baseline at Hour 2, Week 6 | -7.37 mm Hg | Standard Error 0.23 |
| Bimatoprost SR 10 μg | Change From Baseline in IOP in the Study Eye | Change from Baseline at Hour 2, Week 6 | -7.48 mm Hg | Standard Error 0.22 |
| Bimatoprost SR 10 μg | Change From Baseline in IOP in the Study Eye | Change from Baseline at Hour 0, Week 2 | -6.97 mm Hg | Standard Error 0.25 |
| Bimatoprost SR 10 μg | Change From Baseline in IOP in the Study Eye | Change from Baseline at Hour 0, Week 6 | -7.11 mm Hg | Standard Error 0.23 |
| Bimatoprost SR 10 μg | Change From Baseline in IOP in the Study Eye | Change from Baseline at Hour 2, Week 2 | -7.57 mm Hg | Standard Error 0.22 |
| Timolol 0.5%: Comparator | Change From Baseline in IOP in the Study Eye | Change from Baseline at Hour 2, Week 6 | -6.83 mm Hg | Standard Error 0.23 |
| Timolol 0.5%: Comparator | Change From Baseline in IOP in the Study Eye | Change from Baseline at Hour 2, Week 2 | -6.67 mm Hg | Standard Error 0.22 |
| Timolol 0.5%: Comparator | Change From Baseline in IOP in the Study Eye | Change from Baseline at Hour 0, Week 6 | -6.29 mm Hg | Standard Error 0.24 |
| Timolol 0.5%: Comparator | Change From Baseline in IOP in the Study Eye | Change from Baseline at Hour 0, Week 2 | -6.17 mm Hg | Standard Error 0.25 |
Comparison: Change from Baseline Week 2, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).p-value: 0.003395% CI: [-1.68, -0.34]MMRM
Comparison: Change from Baseline Week 2, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).p-value: 0.018795% CI: [-1.47, -0.13]MMRM
Comparison: Change from Baseline Week 2, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).p-value: 0.005795% CI: [-1.45, -0.25]MMRM
Comparison: Change from Baseline Week 2, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).p-value: 0.003195% CI: [-1.5, -0.31]MMRM
Comparison: Change from Baseline Week 6, Hour 0: The null hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).p-value: 0.054795% CI: [-1.26, 0.01]MMRM
Comparison: Change from Baseline Week 6, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).p-value: 0.010795% CI: [-1.46, -0.19]MMRM
Comparison: Change from Baseline Week 6, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).p-value: 0.08695% CI: [-1.16, 0.08]MMRM
Comparison: Change from Baseline Week 6, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).p-value: 0.036295% CI: [-1.27, -0.04]MMRM