Glaucoma, Open-Angle Ocular Hypertension
Conditions
Brief summary
This study will evaluate the intraocular pressure (IOP)-lowering effect and safety of Bimatoprost SR compared with selective laser trabeculoplasty in participants with open-angle glaucoma or ocular hypertension who are not adequately managed with topical IOP-lowering medication for reasons other than medication efficacy (e.g., due to intolerance or nonadherence).
Interventions
DRUGBimatoprost SR
Up to three Bimatoprost SR 15 micrograms (μg) administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Bimatoprost SR 15 μg administrations at Day 4 and Week 16 (Stage 2).
Up to three Sham Bimatoprost SR administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Sham Bimatoprost SR administrations at Day 4 and Week 16 (Stage 2).
PROCEDURESelective Laser Trabeculoplasty
Selective Laser Trabeculoplasty administered on Day 1.
PROCEDURESham Selective Laser Trabeculoplasty
Sham Selective Laser Trabeculoplasty administered on Day 1.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, 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 that require IOP lowering treatment.
Exclusion criteria
* Eye surgery (including cataract surgery) and or eye laser surgery within the past 6 months. * Enrollment in other studies using Bimatoprost SR.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular Pressure (IOP) at Baseline | Baseline (prior to treatment) | IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. |
| Change From Baseline in IOP at Week 4 | Baseline (prior to treatment) to Week 4 | IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening. A mixed-effects model with repeated measures (MMRM) was used for analyses. |
| Change From Baseline in IOP at Week 12 | Baseline (prior to treatment) to Week 12 | IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening. A MMRM was used for analyses. |
| Change From Baseline in Intraocular Pressure (IOP) at Week 24 | Baseline (prior to treatment) to Week 24 | IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening. A MMRM was used for analyses. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Initial Use of Nonstudy IOP-lowering Treatment as Determined by the Investigator | First treatment to end of study (up to 525 days) | Median time in days from first treatment to the initial use of non-study IOP-lowering treatment. |
| Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Baseline (prior to treatment) to Cycle 1: Day 2, Weeks 4, 8, 12, 15, 20, 24, 28, 31, 36, 40, 44, 47, 52; Cycle 2:Day 2, Weeks 4, 8, 12, 15, 20, 24, 28, 31, 36; Cycle 3: Day 2, Weeks 4, 8, 15, 20 | IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. The participants who did not continue in the subsequent cycle were followed up to Week 52 in Cycle 1, Week 36 in Cycle 2, and Week 20 in Cycle 3. |
| Change From Baseline in IOP at Weeks 8, 15, and 20 | Baseline (prior to treatment) to Weeks 8, 15 and 20 | IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening. |
Countries
Australia, Denmark, France, Poland, Russia, Singapore, Spain, Thailand, United States
Participant flow
Pre-assignment details
A total of 144 participants were randomized with 72 participants in each treatment group. Out of them 142 participants were treated. The primary eye was defined as the eye with the higher intraocular pressure (IOP) at Baseline. If both the eyes were the same, the right eye was used as the primary eye. The contralateral eye is the other eye.
Participants by arm
| Arm | Count |
|---|---|
| SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) Primary Eye: Selective Laser Trabeculoplasty (SLT) administered on Day 1 followed by up to three Sham Bimatoprost sustained release (Bim SR) administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.
Contralateral (Other) Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants enrolled under Protocol Amendment 2 or later. | 72 |
| Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye) Primary Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.
Contralateral (Other) Eye: SLT administered on Day 1 followed by up to three Sham Bimatoprost SR administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later. | 72 |
| Total | 144 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Cycle 1 (Day 1 to Week 15) | Lost to Follow-up | 1 | 0 |
| Cycle 1 (Day 1 to Week 15) | Protocol Violation | 0 | 1 |
| Cycle 1 (Day 1 to Week 15) | Randomized but not Treated | 0 | 2 |
| Cycle 1 (Day 1 to Week 15) | Reason not Specified | 0 | 1 |
| Cycle 1 (Day 1 to Week 15) | Withdrawal of Consent | 0 | 1 |
| Cycle 2 (Week 16 to Week 31) | Adverse Event | 2 | 1 |
Baseline characteristics
| Characteristic | SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) | Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye) | Total |
|---|---|---|---|
| Age, Continuous | 57.9 years STANDARD_DEVIATION 10.2 | 62.1 years STANDARD_DEVIATION 11.4 | 60.0 years STANDARD_DEVIATION 11 |
| Race/Ethnicity, Customized Asian | 5 Participants | 3 Participants | 8 Participants |
| Race/Ethnicity, Customized Black or African American | 12 Participants | 9 Participants | 21 Participants |
| Race/Ethnicity, Customized Hispanic | 11 Participants | 7 Participants | 18 Participants |
| Race/Ethnicity, Customized Non-Hispanic | 61 Participants | 64 Participants | 125 Participants |
| Race/Ethnicity, Customized Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 53 Participants | 59 Participants | 112 Participants |
| Sex: Female, Male Female | 28 Participants | 39 Participants | 67 Participants |
| Sex: Female, Male Male | 44 Participants | 33 Participants | 77 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 72 | 0 / 72 |
| other Total, other adverse events | 56 / 72 | 44 / 70 |
| serious Total, serious adverse events | 11 / 72 | 6 / 70 |
Outcome results
Primary
Change From Baseline in Intraocular Pressure (IOP) at Week 24
IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening. A MMRM was used for analyses.
Time frame: Baseline (prior to treatment) to Week 24
Population: mITT Population was defined based in the ITT population but excluded participants who did not receive the second implant after implementation of Amendment 3. Overall number analyzed are number of participants and eyes with data available for analyses.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Selective Laser Trabeculoplasty | Change From Baseline in Intraocular Pressure (IOP) at Week 24 | -6.34 mmHg | Standard Error 0.29 |
| Bim SR 15 μg | Change From Baseline in Intraocular Pressure (IOP) at Week 24 | -6.59 mmHg | Standard Error 0.29 |
Comparison: Change from Baseline at Week 24: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to SLT if the upper limit of the 95% confidence interval (CI) was ≤ 1.5 mmHg at all scheduled visits (Weeks 4, 12, and 24).p-value: 0.392895% CI: [-0.81, 0.32]MMRM
Primary
Change From Baseline in IOP at Week 12
IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening. A MMRM was used for analyses.
Time frame: Baseline (prior to treatment) to Week 12
Population: mITT Population was defined based in the ITT population but excluded participants who did not receive the second implant after implementation of Amendment 3. Overall number analyzed are number of participants and eyes with data available for analyses.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Selective Laser Trabeculoplasty | Change From Baseline in IOP at Week 12 | -6.28 mmHg | Standard Error 0.29 |
| Bim SR 15 μg | Change From Baseline in IOP at Week 12 | -6.81 mmHg | Standard Error 0.29 |
Comparison: Change from Baseline at Week 12: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to SLT if the upper limit of the 95% CI was ≤ 1.5 mmHg at all scheduled visits (Weeks 4, 12, and 24).p-value: 0.073595% CI: [-1.09, 0.05]MMRM
Primary
Change From Baseline in IOP at Week 4
IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening. A mixed-effects model with repeated measures (MMRM) was used for analyses.
Time frame: Baseline (prior to treatment) to Week 4
Population: mITT Population was defined based in the ITT population but excluded participants who did not receive the second implant after implementation of Amendment 3. Overall number analyzed are number of participants and eyes with data available for analyses.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Selective Laser Trabeculoplasty | Change From Baseline in IOP at Week 4 | -6.28 mmHg | Standard Error 0.3 |
| Bim SR 15 μg | Change From Baseline in IOP at Week 4 | -6.98 mmHg | Standard Error 0.29 |
Comparison: Change from Baseline at Week 4: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to SLT if the upper limit of the 95% CI was ≤ 1.5 mmHg at all scheduled visits (Weeks 4, 12, and 24).p-value: 0.016695% CI: [-1.28, -0.13]MMRM
Primary
Intraocular Pressure (IOP) at Baseline
IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0.
Time frame: Baseline (prior to treatment)
Population: Modified Intent-to-Treat (mITT) Population was defined based in the Intent-to-Treat (ITT) population but excluded participants who did not receive the second implant after implementation of Amendment 3.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Selective Laser Trabeculoplasty | Intraocular Pressure (IOP) at Baseline | 24.45 millimeters of mercury (mmHg) | Standard Deviation 2.75 |
| Bim SR 15 μg | Intraocular Pressure (IOP) at Baseline | 24.38 millimeters of mercury (mmHg) | Standard Deviation 2.49 |
Secondary
Change From Baseline in IOP at Weeks 8, 15, and 20
IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening.
Time frame: Baseline (prior to treatment) to Weeks 8, 15 and 20
Population: ITT Population was defined as all randomized participants. Number analyzed is the number of participants and eyes analyzed at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Selective Laser Trabeculoplasty | Change From Baseline in IOP at Weeks 8, 15, and 20 | Change from Baseline at Week 8 | -6.65 mmHg | Standard Deviation 3.1 |
| Selective Laser Trabeculoplasty | Change From Baseline in IOP at Weeks 8, 15, and 20 | Change from Baseline at Week 15 | -6.14 mmHg | Standard Deviation 3.47 |
| Selective Laser Trabeculoplasty | Change From Baseline in IOP at Weeks 8, 15, and 20 | Change from Baseline at Week 20 | -5.06 mmHg | Standard Deviation 3.33 |
| Bim SR 15 μg | Change From Baseline in IOP at Weeks 8, 15, and 20 | Change from Baseline at Week 8 | -7.09 mmHg | Standard Deviation 2.93 |
| Bim SR 15 μg | Change From Baseline in IOP at Weeks 8, 15, and 20 | Change from Baseline at Week 15 | -5.36 mmHg | Standard Deviation 3.73 |
| Bim SR 15 μg | Change From Baseline in IOP at Weeks 8, 15, and 20 | Change from Baseline at Week 20 | -4.29 mmHg | Standard Deviation 1.93 |
Secondary
Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP
IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. The participants who did not continue in the subsequent cycle were followed up to Week 52 in Cycle 1, Week 36 in Cycle 2, and Week 20 in Cycle 3.
Time frame: Baseline (prior to treatment) to Cycle 1: Day 2, Weeks 4, 8, 12, 15, 20, 24, 28, 31, 36, 40, 44, 47, 52; Cycle 2:Day 2, Weeks 4, 8, 12, 15, 20, 24, 28, 31, 36; Cycle 3: Day 2, Weeks 4, 8, 15, 20
Population: ITT Population was defined as all randomized participants. Number analyzed is number of participants and eyes analyzed at the given timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Selective Laser Trabeculoplasty | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 2 Day 2 | 70.2 percentage of participants |
| Selective Laser Trabeculoplasty | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 1 Week 28 | 63.6 percentage of participants |
| Selective Laser Trabeculoplasty | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 2 Week 4 | 68.8 percentage of participants |
| Selective Laser Trabeculoplasty | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 1 Day 2 | 60.6 percentage of participants |
| Selective Laser Trabeculoplasty | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 2 Week 8 | 68.5 percentage of participants |
| Selective Laser Trabeculoplasty | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 1 Week 31 | 100.0 percentage of participants |
| Selective Laser Trabeculoplasty | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 2 Week 12 | 72.0 percentage of participants |
| Selective Laser Trabeculoplasty | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 1 Week 15 | 67.2 percentage of participants |
| Selective Laser Trabeculoplasty | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 2 Week 15 | 69.4 percentage of participants |
| Selective Laser Trabeculoplasty | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 1 Week 36 | 72.7 percentage of participants |
| Selective Laser Trabeculoplasty | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 2 Week 20 | 76.9 percentage of participants |
| Selective Laser Trabeculoplasty | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 1 Week 8 | 72.9 percentage of participants |
| Selective Laser Trabeculoplasty | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 2 Week 24 | 64.4 percentage of participants |
| Selective Laser Trabeculoplasty | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 1 Week 40 | 54.5 percentage of participants |
| Selective Laser Trabeculoplasty | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 2 Week 28 | 76.5 percentage of participants |
| Selective Laser Trabeculoplasty | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 1 Week 20 | 50.0 percentage of participants |
| Selective Laser Trabeculoplasty | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 2 Week 31 | 76.7 percentage of participants |
| Selective Laser Trabeculoplasty | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 1 Week 44 | 81.8 percentage of participants |
| Selective Laser Trabeculoplasty | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 2 Week 36 | 79.1 percentage of participants |
| Selective Laser Trabeculoplasty | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 3 Day 2 | 75.8 percentage of participants |
| Selective Laser Trabeculoplasty | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 1 Week 4 | 70.2 percentage of participants |
| Selective Laser Trabeculoplasty | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 3 Week 4 | 74.2 percentage of participants |
| Selective Laser Trabeculoplasty | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 1 Week 47 | 72.7 percentage of participants |
| Selective Laser Trabeculoplasty | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 3 Week 8 | 75.0 percentage of participants |
| Selective Laser Trabeculoplasty | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 1 Week 24 | 81.8 percentage of participants |
| Selective Laser Trabeculoplasty | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 3 Week 15 | 70.0 percentage of participants |
| Selective Laser Trabeculoplasty | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 1 Week 52 | 81.8 percentage of participants |
| Selective Laser Trabeculoplasty | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 3 Week 20 | 69.7 percentage of participants |
| Selective Laser Trabeculoplasty | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 1 Week 12 | 67.9 percentage of participants |
| Bim SR 15 μg | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 2 Week 12 | 65.3 percentage of participants |
| Bim SR 15 μg | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 1 Day 2 | 92.7 percentage of participants |
| Bim SR 15 μg | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 1 Week 4 | 78.0 percentage of participants |
| Bim SR 15 μg | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 1 Week 8 | 80.0 percentage of participants |
| Bim SR 15 μg | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 1 Week 12 | 75.2 percentage of participants |
| Bim SR 15 μg | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 1 Week 15 | 64.2 percentage of participants |
| Bim SR 15 μg | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 1 Week 20 | 40.0 percentage of participants |
| Bim SR 15 μg | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 1 Week 24 | 45.5 percentage of participants |
| Bim SR 15 μg | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 1 Week 28 | 45.5 percentage of participants |
| Bim SR 15 μg | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 1 Week 31 | 40.0 percentage of participants |
| Bim SR 15 μg | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 1 Week 36 | 72.7 percentage of participants |
| Bim SR 15 μg | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 1 Week 40 | 54.5 percentage of participants |
| Bim SR 15 μg | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 1 Week 44 | 45.5 percentage of participants |
| Bim SR 15 μg | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 1 Week 47 | 54.5 percentage of participants |
| Bim SR 15 μg | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 1 Week 52 | 81.8 percentage of participants |
| Bim SR 15 μg | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 2 Day 2 | 89.5 percentage of participants |
| Bim SR 15 μg | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 2 Week 4 | 75.2 percentage of participants |
| Bim SR 15 μg | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 2 Week 8 | 71.0 percentage of participants |
| Bim SR 15 μg | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 2 Week 36 | 67.0 percentage of participants |
| Bim SR 15 μg | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 2 Week 15 | 64.3 percentage of participants |
| Bim SR 15 μg | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 2 Week 20 | 64.8 percentage of participants |
| Bim SR 15 μg | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 2 Week 24 | 71.3 percentage of participants |
| Bim SR 15 μg | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 2 Week 28 | 74.1 percentage of participants |
| Bim SR 15 μg | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 2 Week 31 | 74.4 percentage of participants |
| Bim SR 15 μg | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 3 Day 2 | 90.9 percentage of participants |
| Bim SR 15 μg | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 3 Week 4 | 71.0 percentage of participants |
| Bim SR 15 μg | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 3 Week 8 | 59.4 percentage of participants |
| Bim SR 15 μg | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 3 Week 15 | 43.3 percentage of participants |
| Bim SR 15 μg | Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | Cycle 3 Week 20 | 39.4 percentage of participants |
Secondary
Time to Initial Use of Nonstudy IOP-lowering Treatment as Determined by the Investigator
Median time in days from first treatment to the initial use of non-study IOP-lowering treatment.
Time frame: First treatment to end of study (up to 525 days)
Population: ITT Population was defined as all randomized participants. Overall number analyzed are number of participants and eyes with data available for analyses.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Selective Laser Trabeculoplasty | Time to Initial Use of Nonstudy IOP-lowering Treatment as Determined by the Investigator | 410 days |
| Bim SR 15 μg | Time to Initial Use of Nonstudy IOP-lowering Treatment as Determined by the Investigator | 446 days |