Glaucoma, Open-Angle, Ocular Hypertension
Conditions
Brief summary
This study will evaluate the efficacy and safety of bimatoprost sustained-release (SR) in patients with open-angle glaucoma or ocular hypertension. The study includes a 12-month treatment period with an 8-month extended follow-up.
Interventions
DRUGBimatoprost SR
Bimatoprost SR administered in the study eye on Day 1, Week 16, and Week 32.
Sham administered on Day 1, Week 16, and Week 32.
Timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
Timolol vehicle administered once in the morning and once in the evening for up to 20 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 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 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 Intraocular Pressure (IOP) in the Study Eye to Week 12 (Hours 0 and 2) | Baseline (Up to 3 days prior to Day 1 at 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 (Up to 3 days prior to Day 1 at 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
Argentina, Canada, Colombia, Czechia, Egypt, Germany, Italy, Malaysia, New Zealand, Singapore, South Africa, South Korea, Turkey (Türkiye), United Kingdom, 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. | 176 |
| 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. | 176 |
| 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. | 176 |
| Total | 528 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Treatment Period 1 (Day 1 to Week 15) | Adverse Event | 0 | 2 | 2 |
| Treatment Period 1 (Day 1 to Week 15) | Lost to Follow-up | 1 | 0 | 0 |
| Treatment Period 1 (Day 1 to Week 15) | Personal Reasons | 2 | 3 | 5 |
| Treatment Period 1 (Day 1 to Week 15) | Protocol Deviation | 1 | 0 | 0 |
| Treatment Period 1 (Day 1 to Week 15) | Randomized but not Treated | 0 | 1 | 3 |
| Treatment Period 1 (Day 1 to Week 15) | Reason not Specified | 0 | 0 | 1 |
| Treatment Period 2 (Week 16 to Week 31) | Adverse Event | 4 | 1 | 0 |
| Treatment Period 2 (Week 16 to Week 31) | Lost to Follow-up | 0 | 0 | 3 |
| Treatment Period 2 (Week 16 to Week 31) | Personal Reasons | 2 | 3 | 2 |
| Treatment Period 2 (Week 16 to Week 31) | Protocol Deviation | 0 | 1 | 0 |
| Treatment Period 2 (Week 16 to Week 31) | Reason not Specified | 0 | 1 | 0 |
| Treatment Period 3 (Week 32 to Week 52) | Adverse Event | 4 | 1 | 1 |
| Treatment Period 3 (Week 32 to Week 52) | Lost to Follow-up | 1 | 2 | 1 |
| Treatment Period 3 (Week 32 to Week 52) | Personal Reasons | 2 | 0 | 2 |
| Treatment Period 3 (Week 32 to Week 52) | Reason not Specified | 2 | 1 | 1 |
Baseline characteristics
| Characteristic | Bimatoprost SR 15 μg | Bimatoprost SR 10 μg | Timolol 0.5%: Comparator | Total |
|---|---|---|---|---|
| Age, Continuous | 63.8 years STANDARD_DEVIATION 10.7 | 62.5 years STANDARD_DEVIATION 12.7 | 61.4 years STANDARD_DEVIATION 12.4 | 62.6 years STANDARD_DEVIATION 12 |
| Intraocular Pressure (IOP) Hour 0 | 24.39 millimeters of mercury (mmHg) | 24.28 millimeters of mercury (mmHg) | 24.46 millimeters of mercury (mmHg) | 24.38 millimeters of mercury (mmHg) |
| Intraocular Pressure (IOP) Hour 2 | 23.41 millimeters of mercury (mmHg) | 23.24 millimeters of mercury (mmHg) | 23.43 millimeters of mercury (mmHg) | 23.36 millimeters of mercury (mmHg) |
| Race/Ethnicity, Customized Asian | 6 Participants | 11 Participants | 13 Participants | 30 Participants |
| Race/Ethnicity, Customized Black or African and American | 19 Participants | 20 Participants | 36 Participants | 75 Participants |
| Race/Ethnicity, Customized Hispanic | 27 Participants | 22 Participants | 21 Participants | 70 Participants |
| Race/Ethnicity, Customized Other | 8 Participants | 8 Participants | 2 Participants | 18 Participants |
| Race/Ethnicity, Customized White | 116 Participants | 115 Participants | 104 Participants | 335 Participants |
| Sex: Female, Male Female | 91 Participants | 90 Participants | 88 Participants | 269 Participants |
| Sex: Female, Male Male | 85 Participants | 86 Participants | 88 Participants | 259 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 176 | 0 / 176 | 1 / 176 |
| other Total, other adverse events | 133 / 176 | 103 / 175 | 72 / 173 |
| serious Total, serious adverse events | 36 / 176 | 22 / 175 | 16 / 173 |
Outcome results
Primary
Change From Baseline in Intraocular Pressure (IOP) in the Study Eye 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.
Time frame: Baseline (Up to 3 days prior to Day 1 at Hours 0 and 2) to Week 12 (Hours 0 and 2)
Population: Participants from the ITT Population, all randomized participants, with data available for analyses.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Bimatoprost SR 15 μg | Change From Baseline in Intraocular Pressure (IOP) in the Study Eye to Week 12 (Hours 0 and 2) | Change from Baseline at Week 12, Hour 0 | -6.47 millimeters of mercury (mmHg) | Standard Error 0.3 |
| Bimatoprost SR 15 μg | Change From Baseline in Intraocular Pressure (IOP) in the Study Eye to Week 12 (Hours 0 and 2) | Change from Baseline at Week 12, Hour 2 | -7.16 millimeters of mercury (mmHg) | Standard Error 0.28 |
| Bimatoprost SR 10 μg | Change From Baseline in Intraocular Pressure (IOP) in the Study Eye to Week 12 (Hours 0 and 2) | Change from Baseline at Week 12, Hour 0 | -6.18 millimeters of mercury (mmHg) | Standard Error 0.3 |
| Bimatoprost SR 10 μg | Change From Baseline in Intraocular Pressure (IOP) in the Study Eye to Week 12 (Hours 0 and 2) | Change from Baseline at Week 12, Hour 2 | -6.72 millimeters of mercury (mmHg) | Standard Error 0.28 |
| Timolol 0.5%: Comparator | Change From Baseline in Intraocular Pressure (IOP) in the Study Eye to Week 12 (Hours 0 and 2) | Change from Baseline at Week 12, Hour 0 | -6.11 millimeters of mercury (mmHg) | Standard Error 0.3 |
| Timolol 0.5%: Comparator | Change From Baseline in Intraocular Pressure (IOP) in the Study Eye to Week 12 (Hours 0 and 2) | Change from Baseline at Week 12, Hour 2 | -6.36 millimeters of mercury (mmHg) | Standard Error 0.29 |
Comparison: Change from Baseline at Week 12, Hour 0: The 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 mmHg for all scheduled timepoints (Hours 0 and 2 at Week 12).p-value: 0.373895% CI: [-1.17, 0.44]MMRM
Comparison: Change from Baseline at Week 12, Hour 0: The 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 mmHg for all scheduled timepoints (Hours 0 and 2 at Week 12).p-value: 0.851495% CI: [-0.88, 0.73]MMRM
Comparison: Change from Baseline at Week 12, Hour 2: The 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 mmHg for all scheduled timepoints (Hours 0 and 2 at Week 12).p-value: 0.040195% CI: [-1.57, -0.04]MMRM
Comparison: Change from Baseline at Week 12, Hour 2: The 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 mmHg for all scheduled timepoints (Hours 0 and 2 at Week 12).p-value: 0.362195% CI: [-1.12, 0.41]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: Participants from the ITT Population, all randomized 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) | 17.39 mmHg | Standard Error 0.3 |
| Bimatoprost SR 10 μg | IOP in the Study Eye at Week 12 (Hour 0) | 17.68 mmHg | Standard Error 0.3 |
| Timolol 0.5%: Comparator | IOP in the Study Eye at Week 12 (Hour 0) | 17.75 mmHg | Standard Error 0.3 |
Comparison: Week 12, Hour 0: The 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 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).p-value: 0.373895% CI: [-1.17, 0.44]MMRM
Comparison: Week 12, Hour 0: The 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 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).p-value: 0.851495% CI: [-0.88, 0.73]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: Participants from the ITT Population, all randomized 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) | 16.70 mmHg | Standard Error 0.28 |
| Bimatoprost SR 10 μg | IOP in the Study Eye at Week 12 (Hour 2) | 17.15 mmHg | Standard Error 0.28 |
| Timolol 0.5%: Comparator | IOP in the Study Eye at Week 12 (Hour 2) | 17.50 mmHg | Standard Error 0.29 |
Comparison: Week 12, Hour 2: The 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 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).p-value: 0.040195% CI: [-1.57, -0.04]MMRM
Comparison: Week 12, Hour 2: The 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 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).p-value: 0.362195% CI: [-1.12, 0.41]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: Participants from the ITT Population, all randomized 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) | 16.74 mmHg | Standard Error 0.27 |
| Bimatoprost SR 10 μg | IOP in the Study Eye at Week 2 (Hour 0) | 16.92 mmHg | Standard Error 0.27 |
| Timolol 0.5%: Comparator | IOP in the Study Eye at Week 2 (Hour 0) | 17.50 mmHg | Standard Error 0.27 |
Comparison: Week 2, Hour 0: The 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 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).p-value: 0.038295% CI: [-1.48, -0.04]MMRM
Comparison: Week 2, Hour 0: The 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 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).p-value: 0.113395% CI: [-1.29, 0.14]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: Participants from the ITT Population, all randomized 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) | 16.09 mmHg | Standard Error 0.25 |
| Bimatoprost SR 10 μg | IOP in the Study Eye at Week 2 (Hour 2) | 16.48 mmHg | Standard Error 0.25 |
| Timolol 0.5%: Comparator | IOP in the Study Eye at Week 2 (Hour 2) | 17.19 mmHg | Standard Error 0.25 |
Comparison: Week 2, Hour 2: The 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 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).p-value: 0.001395% CI: [-1.76, -0.43]MMRM
Comparison: Week 2, Hour 2: The 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 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).p-value: 0.036495% CI: [-1.38, -0.05]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: Participants from the ITT Population, all randomized 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) | 17.05 mmHg | Standard Error 0.28 |
| Bimatoprost SR 10 μg | IOP in the Study Eye at Week 6 (Hour 0) | 16.93 mmHg | Standard Error 0.28 |
| Timolol 0.5%: Comparator | IOP in the Study Eye at Week 6 (Hour 0) | 17.51 mmHg | Standard Error 0.29 |
Comparison: Week 6, Hour 0: The 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 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).p-value: 0.230495% CI: [-1.22, 0.29]MMRM
Comparison: Week 6, Hour 0: The 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 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).p-value: 0.127295% CI: [-1.34, 0.17]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: Participants from the ITT Population, all randomized 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) | 16.13 mmHg | Standard Error 0.26 |
| Bimatoprost SR 10 μg | IOP in the Study Eye at Week 6 (Hour 2) | 16.53 mmHg | Standard Error 0.26 |
| Timolol 0.5%: Comparator | IOP in the Study Eye at Week 6 (Hour 2) | 17.18 mmHg | Standard Error 0.27 |
Comparison: Week 6, Hour 2: The 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 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).p-value: 0.003895% CI: [-1.76, -0.34]MMRM
Comparison: Week 6, Hour 2: The 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 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).p-value: 0.074195% CI: [-1.36, 0.06]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 (Up to 3 days prior to Day 1 at Hours 0 and 2) to Weeks 2 and 6 (Hours 0 and 2)
Population: Participants from the ITT Population, all randomized participants, with data available for analyses.
| 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 Week 2, Hour 0 | -7.12 mmHg | Standard Error 0.27 |
| Bimatoprost SR 15 μg | Change From Baseline in IOP in the Study Eye | Change from Baseline at Week 2, Hour 2 | -7.77 mmHg | Standard Error 0.25 |
| Bimatoprost SR 15 μg | Change From Baseline in IOP in the Study Eye | Change from Baseline at Week 6, Hour 0 | -6.81 mmHg | Standard Error 0.28 |
| Bimatoprost SR 15 μg | Change From Baseline in IOP in the Study Eye | Change from Baseline at Week 6, Hour 2 | -7.74 mmHg | Standard Error 0.26 |
| Bimatoprost SR 10 μg | Change From Baseline in IOP in the Study Eye | Change from Baseline at Week 6, Hour 2 | -7.33 mmHg | Standard Error 0.26 |
| Bimatoprost SR 10 μg | Change From Baseline in IOP in the Study Eye | Change from Baseline at Week 2, Hour 0 | -6.94 mmHg | Standard Error 0.27 |
| Bimatoprost SR 10 μg | Change From Baseline in IOP in the Study Eye | Change from Baseline at Week 6, Hour 0 | -6.93 mmHg | Standard Error 0.28 |
| Bimatoprost SR 10 μg | Change From Baseline in IOP in the Study Eye | Change from Baseline at Week 2, Hour 2 | -7.38 mmHg | Standard Error 0.25 |
| Timolol 0.5%: Comparator | Change From Baseline in IOP in the Study Eye | Change from Baseline at Week 6, Hour 2 | -6.69 mmHg | Standard Error 0.27 |
| Timolol 0.5%: Comparator | Change From Baseline in IOP in the Study Eye | Change from Baseline at Week 2, Hour 2 | -6.67 mmHg | Standard Error 0.25 |
| Timolol 0.5%: Comparator | Change From Baseline in IOP in the Study Eye | Change from Baseline at Week 6, Hour 0 | -6.35 mmHg | Standard Error 0.29 |
| Timolol 0.5%: Comparator | Change From Baseline in IOP in the Study Eye | Change from Baseline at Week 2, Hour 0 | -6.36 mmHg | Standard Error 0.27 |
Comparison: Change from Baseline at Week 2, Hour 0: The 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 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).p-value: 0.038295% CI: [-1.48, -0.04]MMRM
Comparison: Change from Baseline at Week 2, Hour 0: The 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 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).p-value: 0.113395% CI: [-1.29, 0.14]MMRM
Comparison: Change from Baseline at Week 2, Hour 2: The 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 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).p-value: 0.001395% CI: [-1.76, -0.43]MMRM
Comparison: Change from Baseline at Week 2, Hour 2: The 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 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).p-value: 0.036495% CI: [-1.38, -0.05]MMRM
Comparison: Change from Baseline at Week 6, Hour 0: The 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 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).p-value: 0.230495% CI: [-1.22, 0.29]MMRM
Comparison: Change from Baseline at Week 6, Hour 0: The 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 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).p-value: 0.127295% CI: [-1.34, 0.17]MMRM
Comparison: Change from Baseline at Week 6, Hour 2: The 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 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).p-value: 0.003895% CI: [-1.76, -0.34]MMRM
Comparison: Change from Baseline at Week 6, Hour 2: The 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 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).p-value: 0.074195% CI: [-1.36, 0.06]MMRM