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 patients 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
Bimatoprost SR is a biodegradable, sustained-release, preservative-free bimatoprost implant, preloaded in an applicator for administration. The Bimatoprost SR implant is injected into the anterior chamber via the corneal limbus using the prefilled applicator.
Sham bimatoprost SR performed using the same procedure as for Bimatoprost SR using an needleless applicator that touches the eye at the area of insertion but does not deliver an implant into the anterior chamber.
PROCEDURESelective Laser Trabeculoplasty
SLT is a laser procedure that targets the melanin, or pigment, in specific cells of the eye. An ophthalmologist performed 360 degrees of SLT using a standardized method.
PROCEDURESham Selective Laser Trabeculoplasty
Sham SLT is performed on the contralateral eye using the same method as for SLT, with the exception that the laser is not switched to the active state.
Sponsors
AbbVie
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. * In the investigator's opinion, patient's IOP is not adequately managed with topical medication for reasons other than medication efficacy (eg, due to intolerance or nonadherence). * In the investigator's opinion, both eyes can be treated adequately with topical prostamide, prostaglandin, or prostaglandin analog eye drops as the sole therapy if medication was taken as directed, or with SLT monotherapy.
Exclusion criteria
* History of previous laser trabeculoplasty * History or evidence of complicated cataract surgery: eg, surgery resulting in complicated lens placement (such as anterior chamber intraocular lens implant \[IOL\], sulcus IOL, aphakia, etc) or intraoperative complications (such as a posterior capsular tear \[with or without vitreous loss\], substantial iris trauma, etc) or history of phakic IOL insertion for refractive error correction * Intraocular surgery (including cataract surgery) and/or any ocular laser surgery within the 6 months prior to treatment * Previous use of commercially available Bimatoprost SR; concurrent enrollment in another Allergan Bimatoprost SR study; or previous enrollment in which an implant was received.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Intraocular Pressure at Week 4 | Baseline and Week 4 | Intraocular pressure was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer. A negative change from Baseline indicates a decrease (improvement) in intraocular pressure. A mixed-effects model with repeated measures (MMRM) was used for the analysis. IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis. |
| Change From Baseline in Intraocular Pressure at Week 12 | Baseline and Week 12 | Intraocular pressure was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer. A negative change from Baseline indicates a decrease (improvement) in intraocular pressure. An MMRM was used for the analysis. IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis. |
| Change From Baseline in Intraocular Pressure at Week 24 | Baseline and Week 24 | Intraocular pressure was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer. A negative change from Baseline indicates a decrease (improvement) in intraocular pressure. An MMRM was used for the analysis. IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Initial Use of Non-study IOP-lowering Treatment | From first administration of study treatment to the end of study; overall median follow-up time of 728 days. | The time from the date of initial treatment to the date date of first use of non-study IOP-lowering treatment (rescue) was analyzed using the Kaplan-Meier method. If a participant did not use any non-study IOP-lowering treatment in an eye, then the event (initial use of non-study IOP-lowering treatment) time was censored at the study exit date or the last visit date if the study exit date was not available. |
| Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Baseline, Day 2, Weeks 4, 8, 12, 15, 20, 24, 28, 31, 36, 40, 44, 47, 52, Months 13, 14, 15, 16, 18, 20, 22, 24 | Intraocular pressure was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer. For by-cycle analyses, cycle number refers to the administration cycle for bimatoprost SR, or sham bimatoprost SR administration in SLT-treated eyes. For SLT-treated eyes cycle number does not refer to SLT administrations, because SLT was only performed once (Day 1). The Day/Week number refers to the number of days/weeks after bimatoprost SR/sham bimatoprost SR administration. IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis. |
| Change From Baseline in IOP at Weeks 8, 15, and 20 | Baseline and Weeks 8, 15, and 20 | IOP was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer. A negative change from Baseline indicates a decrease (improvement) in intraocular pressure. IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis. |
Countries
Australia, Canada, Denmark, France, Germany, Israel, New Zealand, Philippines, Poland, Russia, United Kingdom, United States
Participant flow
Recruitment details
Participants were randomized at 61 sites in 11 countries (Australia, Canada, Germany, Denmark, France, Great Britain, Israel, New Zealand, Philippines, Poland, and the US). The eye with the higher intraocular pressure (IOP) at Baseline was assigned as the primary eye. If Baseline IOP was the same in both eyes, the right eye was the primary eye.
Pre-assignment details
The primary eye was randomized to receive either bimatoprost sustained release (SR) or selective laser trabeculoplasty (SLT) using a 1:1 ratio. If the primary eye received bimatoprost SR, the contralateral eye received SLT. If the primary eye received SLT, the contralateral eye received bimatoprost SR.
Participants by arm
| Arm | Count |
|---|---|
| Stage 1: SLT (Primary Eye) / Bimatoprost SR 15 μg (Contralateral Eye) Participants enrolled prior to implementation of Protocol Amendment 3 (August 2018) received the following treatment in each eye:
Assigned Primary Eye: Selective laser trabeculoplasty (SLT) administered on Day 1 followed by up to three sham bimatoprost SR administrations.
Contralateral Eye: Sham SLT administered on Day 1 followed by up to three bimatoprost SR 15 μg administrations.
Bimatoprost SR/sham bimatoprost SR was administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2) and Week 32 (Cycle 3; participants who reached Week 32 prior to implementation of Protocol Amendment 3 only). | 29 |
| Stage 1: Bimatoprost SR 15 μg (Primary Eye) / SLT Contralateral Eye) Participants enrolled prior to implementation of Protocol Amendment 3 received the following treatment in each eye:
Assigned Primary Eye: Sham SLT administered on Day 1 followed by up to three bimatoprost SR 15 μg administrations. Contralateral Eye: SLT administered on Day 1 followed by up to three sham bimatoprost SR administrations.
Bimatoprost SR/sham bimatoprost SR was administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2) and Week 32 (Cycle 3; participants who reached Week 32 prior to implementation of Protocol Amendment 3 only). | 28 |
| Stage 2: SLT (Primary Eye) / Bimatoprost SR 10 μg (Contralateral Eye) Participants enrolled after implementation of Protocol Amendment 3 received the following treatment in each eye:
Assigned Primary Eye: SLT administered on Day 1 followed by up to two sham bimatoprost SR administrations.
Contralateral Eye: Sham SLT administered on Day 1 followed by up to two bimatoprost SR 10 μg administrations. Bimatoprost SR/sham bimatoprost SR was administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2). After implementation of Protocol Amendment 6, Cycle 2 retreatment could have occurred after Week 16 and prior to Month 12 based on when retreatment criteria were met. | 92 |
| Stage 2: Bimatoprost SR 10 μg (Primary Eye) / SLT (Contralateral Eye) Participants enrolled after implementation of Protocol Amendment 3 received the following treatment in each eye: Assigned Primary Eye: Sham SLT administered on Day 1 followed by up to two bimatoprost SR 10 μg administrations. Contralateral Eye: SLT administered on Day 1 followed by up to two sham bimatoprost SR administrations.
Bimatoprost SR/sham bimatoprost SR was administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2). After implementation of Protocol Amendment 6, Cycle 2 retreatment could have occurred after Week 16 and prior to Month 12 based on when retreatment criteria were met. | 91 |
| Total | 240 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 2 | 2 | 2 |
| Overall Study | Lost to Follow-up | 0 | 0 | 2 | 1 |
| Overall Study | Other, Not Specified | 0 | 0 | 2 | 4 |
| Overall Study | Protocol Violation | 1 | 0 | 2 | 0 |
| Overall Study | Screen Failure | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 4 | 6 | 6 |
Baseline characteristics
| Characteristic | Total | Stage 1: Bimatoprost SR 15 μg (Primary Eye) / SLT Contralateral Eye) | Stage 1: SLT (Primary Eye) / Bimatoprost SR 15 μg (Contralateral Eye) | Stage 2: Bimatoprost SR 10 μg (Primary Eye) / SLT (Contralateral Eye) | Stage 2: SLT (Primary Eye) / Bimatoprost SR 10 μg (Contralateral Eye) |
|---|---|---|---|---|---|
| Age, Continuous Stage 1 | 62.3 years STANDARD_DEVIATION 13.11 | 59.6 years STANDARD_DEVIATION 13.59 | 64.9 years STANDARD_DEVIATION 12.32 | — | — |
| Age, Continuous Stage 2 | 62.4 years STANDARD_DEVIATION 11.16 | — | — | 62.1 years STANDARD_DEVIATION 10.74 | 62.6 years STANDARD_DEVIATION 11.61 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 21 Participants | 4 Participants | 1 Participants | 10 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 219 Participants | 24 Participants | 28 Participants | 81 Participants | 86 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 participants | 0 participants | 0 participants | 2 participants | 0 participants |
| Race/Ethnicity, Customized Asian | 16 participants | 3 participants | 3 participants | 6 participants | 4 participants |
| Race/Ethnicity, Customized Black or African American | 44 participants | 2 participants | 1 participants | 14 participants | 27 participants |
| Race/Ethnicity, Customized Not Reported | 3 participants | 0 participants | 0 participants | 0 participants | 3 participants |
| Race/Ethnicity, Customized White | 175 participants | 23 participants | 25 participants | 69 participants | 58 participants |
| Sex: Female, Male Female | 122 Participants | 12 Participants | 16 Participants | 48 Participants | 46 Participants |
| Sex: Female, Male Male | 118 Participants | 16 Participants | 13 Participants | 43 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 57 | 0 / 57 | 2 / 183 | 2 / 183 |
| other Total, other adverse events | 41 / 56 | 49 / 55 | 107 / 180 | 121 / 175 |
| serious Total, serious adverse events | 3 / 56 | 3 / 55 | 18 / 180 | 22 / 175 |
Outcome results
Primary
Change From Baseline in Intraocular Pressure at Week 12
Intraocular pressure was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer. A negative change from Baseline indicates a decrease (improvement) in intraocular pressure. An MMRM was used for the analysis. IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis.
Time frame: Baseline and Week 12
Population: The ITT population is defined as all randomized participants. Primary efficacy analysis was performed for participants enrolled in Stage 2. Overall Number of Participants / Units Analyzed reflects the number of participants and eyes with data available for the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Stage 2: SLT | Change From Baseline in Intraocular Pressure at Week 12 | -6.4 mmHg | Standard Error 0.3 |
| Stage 2: Bimatoprost SR 10 µg | Change From Baseline in Intraocular Pressure at Week 12 | -6.9 mmHg | Standard Error 0.3 |
p-value: 0.161595% CI: [-1.04, 0.18]Mixed Effect Model Repeated Measurement
Primary
Change From Baseline in Intraocular Pressure at Week 24
Intraocular pressure was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer. A negative change from Baseline indicates a decrease (improvement) in intraocular pressure. An MMRM was used for the analysis. IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis.
Time frame: Baseline and Week 24
Population: The ITT population is defined as all randomized participants. Primary efficacy analysis was performed for participants enrolled in Stage 2. Overall Number of Participants / Units Analyzed reflects the number of participants and eyes with data available for the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Stage 2: SLT | Change From Baseline in Intraocular Pressure at Week 24 | -6.5 mmHg | Standard Error 0.28 |
| Stage 2: Bimatoprost SR 10 µg | Change From Baseline in Intraocular Pressure at Week 24 | -6.9 mmHg | Standard Error 0.27 |
p-value: 0.167395% CI: [-0.97, 0.17]Mixed Effect Model Repeated Measurement
Primary
Change From Baseline in Intraocular Pressure at Week 4
Intraocular pressure was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer. A negative change from Baseline indicates a decrease (improvement) in intraocular pressure. A mixed-effects model with repeated measures (MMRM) was used for the analysis. IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis.
Time frame: Baseline and Week 4
Population: The intent-to-treat (ITT) population is defined as all randomized participants. Primary efficacy analysis was performed for participants enrolled in Stage 2. Overall Number of Participants / Units Analyzed reflects the number of participants and eyes with data available for the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Stage 2: SLT | Change From Baseline in Intraocular Pressure at Week 4 | -6.2 mmHg | Standard Error 0.28 |
| Stage 2: Bimatoprost SR 10 µg | Change From Baseline in Intraocular Pressure at Week 4 | -6.8 mmHg | Standard Error 0.28 |
p-value: 0.023195% CI: [-1.03, -0.08]Mixed Effect Model Repeated Measurement
Secondary
Change From Baseline in IOP at Weeks 8, 15, and 20
IOP was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer. A negative change from Baseline indicates a decrease (improvement) in intraocular pressure. IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis.
Time frame: Baseline and Weeks 8, 15, and 20
Population: Intent-to-treat poulation participants enrolled in Stage 2 with available IOP data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 2: SLT | Change From Baseline in IOP at Weeks 8, 15, and 20 | Week 8 | -6.1 mmHg | Standard Deviation 3.52 |
| Stage 2: SLT | Change From Baseline in IOP at Weeks 8, 15, and 20 | Week 20 | -5.9 mmHg | Standard Deviation 3.44 |
| Stage 2: SLT | Change From Baseline in IOP at Weeks 8, 15, and 20 | Week 15 | -6.0 mmHg | Standard Deviation 3.58 |
| Stage 2: SLT | Change From Baseline in IOP at Weeks 8, 15, and 20 | Baseline | 25.1 mmHg | Standard Deviation 3 |
| Stage 2: Bimatoprost SR 10 µg | Change From Baseline in IOP at Weeks 8, 15, and 20 | Week 15 | -6.0 mmHg | Standard Deviation 4.36 |
| Stage 2: Bimatoprost SR 10 µg | Change From Baseline in IOP at Weeks 8, 15, and 20 | Week 8 | -6.8 mmHg | Standard Deviation 3.96 |
| Stage 2: Bimatoprost SR 10 µg | Change From Baseline in IOP at Weeks 8, 15, and 20 | Baseline | 25.2 mmHg | Standard Deviation 2.99 |
| Stage 2: Bimatoprost SR 10 µg | Change From Baseline in IOP at Weeks 8, 15, and 20 | Week 20 | -6.4 mmHg | Standard Deviation 3.97 |
Secondary
Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle
Intraocular pressure was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer. For by-cycle analyses, cycle number refers to the administration cycle for bimatoprost SR, or sham bimatoprost SR administration in SLT-treated eyes. For SLT-treated eyes cycle number does not refer to SLT administrations, because SLT was only performed once (Day 1). The Day/Week number refers to the number of days/weeks after bimatoprost SR/sham bimatoprost SR administration. IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis.
Time frame: Baseline, Day 2, Weeks 4, 8, 12, 15, 20, 24, 28, 31, 36, 40, 44, 47, 52, Months 13, 14, 15, 16, 18, 20, 22, 24
Population: Participants/eyes enrolled in Stage 2 with available IOP data at Baseline and each time point; participants who received retreatment with bimatoprost SR/sham bimatoprost SR at or after Week 16 are not included in Cycle 1 time points from the date of retreatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 2: SLT | Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Week 4 | 68.5 percentage of eyes |
| Stage 2: SLT | Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Week 36 | 68.3 percentage of eyes |
| Stage 2: SLT | Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Month 14 | 73.4 percentage of eyes |
| Stage 2: SLT | Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Week 12 | 71.1 percentage of eyes |
| Stage 2: SLT | Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Month 15 | 72.0 percentage of eyes |
| Stage 2: SLT | Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Week 40 | 72.1 percentage of eyes |
| Stage 2: SLT | Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Month 16 | 76.8 percentage of eyes |
| Stage 2: SLT | Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Week 28 | 72.1 percentage of eyes |
| Stage 2: SLT | Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Month 18 | 75.0 percentage of eyes |
| Stage 2: SLT | Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Week 44 | 65.5 percentage of eyes |
| Stage 2: SLT | Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Month 20 | 79.5 percentage of eyes |
| Stage 2: SLT | Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Month 24 | 73.2 percentage of eyes |
| Stage 2: SLT | Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Week 20 | 62.8 percentage of eyes |
| Stage 2: SLT | Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Day 2 | 59.1 percentage of eyes |
| Stage 2: SLT | Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Week 47 | 83.3 percentage of eyes |
| Stage 2: SLT | Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Week 8 | 64.0 percentage of eyes |
| Stage 2: SLT | Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Week 15 | 65.3 percentage of eyes |
| Stage 2: SLT | Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Week 24 | 73.2 percentage of eyes |
| Stage 2: SLT | Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Month 13 | 73.1 percentage of eyes |
| Stage 2: SLT | Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Week 31 | 67.5 percentage of eyes |
| Stage 2: SLT | Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Month 22 | 78.6 percentage of eyes |
| Stage 2: SLT | Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Week 52 | 78.4 percentage of eyes |
| Stage 2: Bimatoprost SR 10 µg | Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Month 15 | 61.2 percentage of eyes |
| Stage 2: Bimatoprost SR 10 µg | Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Week 8 | 75.3 percentage of eyes |
| Stage 2: Bimatoprost SR 10 µg | Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Week 12 | 71.8 percentage of eyes |
| Stage 2: Bimatoprost SR 10 µg | Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Week 15 | 61.2 percentage of eyes |
| Stage 2: Bimatoprost SR 10 µg | Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Week 20 | 67.3 percentage of eyes |
| Stage 2: Bimatoprost SR 10 µg | Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Week 24 | 75.2 percentage of eyes |
| Stage 2: Bimatoprost SR 10 µg | Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Week 28 | 71.4 percentage of eyes |
| Stage 2: Bimatoprost SR 10 µg | Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Week 31 | 62.1 percentage of eyes |
| Stage 2: Bimatoprost SR 10 µg | Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Week 36 | 55.5 percentage of eyes |
| Stage 2: Bimatoprost SR 10 µg | Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Week 40 | 62.0 percentage of eyes |
| Stage 2: Bimatoprost SR 10 µg | Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Week 44 | 57.9 percentage of eyes |
| Stage 2: Bimatoprost SR 10 µg | Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Week 47 | 70.9 percentage of eyes |
| Stage 2: Bimatoprost SR 10 µg | Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Week 52 | 66.4 percentage of eyes |
| Stage 2: Bimatoprost SR 10 µg | Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Month 13 | 65.7 percentage of eyes |
| Stage 2: Bimatoprost SR 10 µg | Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Month 14 | 56.9 percentage of eyes |
| Stage 2: Bimatoprost SR 10 µg | Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Day 2 | 86.6 percentage of eyes |
| Stage 2: Bimatoprost SR 10 µg | Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Month 16 | 70.8 percentage of eyes |
| Stage 2: Bimatoprost SR 10 µg | Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Month 18 | 60.3 percentage of eyes |
| Stage 2: Bimatoprost SR 10 µg | Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Month 24 | 66.7 percentage of eyes |
| Stage 2: Bimatoprost SR 10 µg | Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Week 4 | 71.2 percentage of eyes |
| Stage 2: Bimatoprost SR 10 µg | Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Month 20 | 62.3 percentage of eyes |
| Stage 2: Bimatoprost SR 10 µg | Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle | Month 22 | 69.1 percentage of eyes |
Secondary
Time to Initial Use of Non-study IOP-lowering Treatment
The time from the date of initial treatment to the date date of first use of non-study IOP-lowering treatment (rescue) was analyzed using the Kaplan-Meier method. If a participant did not use any non-study IOP-lowering treatment in an eye, then the event (initial use of non-study IOP-lowering treatment) time was censored at the study exit date or the last visit date if the study exit date was not available.
Time frame: From first administration of study treatment to the end of study; overall median follow-up time of 728 days.
Population: Participants in the ITT population enrolled in Stage 2; eyes that received study treatment are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 2: SLT | Time to Initial Use of Non-study IOP-lowering Treatment | 25% percentile | 263 days |
| Stage 2: SLT | Time to Initial Use of Non-study IOP-lowering Treatment | 50% percentile | NA days |
| Stage 2: SLT | Time to Initial Use of Non-study IOP-lowering Treatment | 75% percentile | NA days |
| Stage 2: Bimatoprost SR 10 µg | Time to Initial Use of Non-study IOP-lowering Treatment | 25% percentile | 276 days |
| Stage 2: Bimatoprost SR 10 µg | Time to Initial Use of Non-study IOP-lowering Treatment | 50% percentile | 732 days |
| Stage 2: Bimatoprost SR 10 µg | Time to Initial Use of Non-study IOP-lowering Treatment | 75% percentile | NA days |