Trial Outcomes & Findings for Comparison of Bimatoprost Sustained Release (SR) to Selective Laser Trabeculoplasty (SLT) in Adults With Open-Angle Glaucoma or Ocular Hypertension (NCT NCT02507687)
NCT ID: NCT02507687
Last Updated: 2024-05-10
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
240 participants
Primary outcome timeframe
Baseline and Week 4
Results posted on
2024-05-10
Participant Flow
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.
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.
Participant milestones
| Measure |
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).
|
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).
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
29
|
28
|
92
|
91
|
|
Overall Study
Received Treatment
|
29
|
27
|
90
|
90
|
|
Overall Study
COMPLETED
|
24
|
22
|
77
|
78
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
15
|
13
|
Reasons for withdrawal
| Measure |
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).
|
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).
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
2
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
4
|
6
|
6
|
|
Overall Study
Protocol Violation
|
1
|
0
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
2
|
1
|
|
Overall Study
Screen Failure
|
0
|
0
|
1
|
0
|
|
Overall Study
Other, Not Specified
|
0
|
0
|
2
|
4
|
Baseline Characteristics
Demographic data were analyzed separately for participants in Stage 1 and Stage 2.
Baseline characteristics by cohort
| Measure |
Stage 1: SLT (Primary Eye) / Bimatoprost SR 15 μg (Contralateral Eye)
n=29 Participants
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).
|
Stage 1: Bimatoprost SR 15 μg (Primary Eye) / SLT Contralateral Eye)
n=28 Participants
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).
|
Stage 2: SLT (Primary Eye) / Bimatoprost SR 10 μg (Contralateral Eye)
n=92 Participants
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.
|
Stage 2: Bimatoprost SR 10 μg (Primary Eye) / SLT (Contralateral Eye)
n=91 Participants
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.
|
Total
n=240 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
Stage 1
|
64.9 years
STANDARD_DEVIATION 12.32 • n=29 Participants • Demographic data were analyzed separately for participants in Stage 1 and Stage 2.
|
59.6 years
STANDARD_DEVIATION 13.59 • n=28 Participants • Demographic data were analyzed separately for participants in Stage 1 and Stage 2.
|
—
|
—
|
62.3 years
STANDARD_DEVIATION 13.11 • n=57 Participants • Demographic data were analyzed separately for participants in Stage 1 and Stage 2.
|
|
Age, Continuous
Stage 2
|
—
|
—
|
62.6 years
STANDARD_DEVIATION 11.61 • n=92 Participants • Demographic data were analyzed separately for participants in Stage 1 and Stage 2.
|
62.1 years
STANDARD_DEVIATION 10.74 • n=91 Participants • Demographic data were analyzed separately for participants in Stage 1 and Stage 2.
|
62.4 years
STANDARD_DEVIATION 11.16 • n=183 Participants • Demographic data were analyzed separately for participants in Stage 1 and Stage 2.
|
|
Sex: Female, Male
Female
|
16 Participants
n=29 Participants
|
12 Participants
n=28 Participants
|
46 Participants
n=92 Participants
|
48 Participants
n=91 Participants
|
122 Participants
n=240 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=29 Participants
|
16 Participants
n=28 Participants
|
46 Participants
n=92 Participants
|
43 Participants
n=91 Participants
|
118 Participants
n=240 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=29 Participants
|
4 Participants
n=28 Participants
|
6 Participants
n=92 Participants
|
10 Participants
n=91 Participants
|
21 Participants
n=240 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=29 Participants
|
24 Participants
n=28 Participants
|
86 Participants
n=92 Participants
|
81 Participants
n=91 Participants
|
219 Participants
n=240 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=29 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=92 Participants
|
0 Participants
n=91 Participants
|
0 Participants
n=240 Participants
|
|
Race/Ethnicity, Customized
White
|
25 participants
n=29 Participants
|
23 participants
n=28 Participants
|
58 participants
n=92 Participants
|
69 participants
n=91 Participants
|
175 participants
n=240 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 participants
n=29 Participants
|
2 participants
n=28 Participants
|
27 participants
n=92 Participants
|
14 participants
n=91 Participants
|
44 participants
n=240 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 participants
n=29 Participants
|
3 participants
n=28 Participants
|
4 participants
n=92 Participants
|
6 participants
n=91 Participants
|
16 participants
n=240 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=29 Participants
|
0 participants
n=28 Participants
|
0 participants
n=92 Participants
|
2 participants
n=91 Participants
|
2 participants
n=240 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 participants
n=29 Participants
|
0 participants
n=28 Participants
|
3 participants
n=92 Participants
|
0 participants
n=91 Participants
|
3 participants
n=240 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 4Population: 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.
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.
Outcome measures
| Measure |
Stage 2: SLT
n=168 Eyes
One 360° administration of SLT on Day 1 followed by up to two sham bimatoprost SR administrations.
|
Stage 2: Bimatoprost SR 10 µg
n=170 Eyes
Sham SLT on Day 1 followed by bimatoprost SR 10 µg administered on Day 4 with repeat administration at Week 16 or after Week 16 and prior to Month 12 depending on when retreatment criteria were met.
|
|---|---|---|
|
Change From Baseline in Intraocular Pressure at Week 4
|
-6.2 mmHg
Standard Error 0.28
|
-6.8 mmHg
Standard Error 0.28
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: 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.
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.
Outcome measures
| Measure |
Stage 2: SLT
n=149 Eyes
One 360° administration of SLT on Day 1 followed by up to two sham bimatoprost SR administrations.
|
Stage 2: Bimatoprost SR 10 µg
n=156 Eyes
Sham SLT on Day 1 followed by bimatoprost SR 10 µg administered on Day 4 with repeat administration at Week 16 or after Week 16 and prior to Month 12 depending on when retreatment criteria were met.
|
|---|---|---|
|
Change From Baseline in Intraocular Pressure at Week 12
|
-6.4 mmHg
Standard Error 0.30
|
-6.9 mmHg
Standard Error 0.30
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: 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.
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.
Outcome measures
| Measure |
Stage 2: SLT
n=138 Eyes
One 360° administration of SLT on Day 1 followed by up to two sham bimatoprost SR administrations.
|
Stage 2: Bimatoprost SR 10 µg
n=145 Eyes
Sham SLT on Day 1 followed by bimatoprost SR 10 µg administered on Day 4 with repeat administration at Week 16 or after Week 16 and prior to Month 12 depending on when retreatment criteria were met.
|
|---|---|---|
|
Change From Baseline in Intraocular Pressure at Week 24
|
-6.5 mmHg
Standard Error 0.28
|
-6.9 mmHg
Standard Error 0.27
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Stage 2: SLT
n=180 Eyes
One 360° administration of SLT on Day 1 followed by up to two sham bimatoprost SR administrations.
|
Stage 2: Bimatoprost SR 10 µg
n=175 Eyes
Sham SLT on Day 1 followed by bimatoprost SR 10 µg administered on Day 4 with repeat administration at Week 16 or after Week 16 and prior to Month 12 depending on when retreatment criteria were met.
|
|---|---|---|
|
Time to Initial Use of Non-study IOP-lowering Treatment
25% percentile
|
263 days
Interval 167.0 to 329.0
|
276 days
Interval 217.0 to 323.0
|
|
Time to Initial Use of Non-study IOP-lowering Treatment
50% percentile
|
NA days
Interval 736.0 to
Data could not be estimated due to the low number of events.
|
732 days
Interval 496.0 to
Data could not be estimated due to the low number of events.
|
|
Time to Initial Use of Non-study IOP-lowering Treatment
75% percentile
|
NA days
Data could not be estimated due to the low number of events.
|
NA days
Data could not be estimated due to the low number of events.
|
SECONDARY outcome
Timeframe: 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, 24Population: 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.
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.
Outcome measures
| Measure |
Stage 2: SLT
n=183 Eyes
One 360° administration of SLT on Day 1 followed by up to two sham bimatoprost SR administrations.
|
Stage 2: Bimatoprost SR 10 µg
n=183 Eyes
Sham SLT on Day 1 followed by bimatoprost SR 10 µg administered on Day 4 with repeat administration at Week 16 or after Week 16 and prior to Month 12 depending on when retreatment criteria were met.
|
|---|---|---|
|
Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle
Day 2
|
59.1 percentage of eyes
|
86.6 percentage of eyes
|
|
Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle
Week 4
|
68.5 percentage of eyes
|
71.2 percentage of eyes
|
|
Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle
Week 8
|
64.0 percentage of eyes
|
75.3 percentage of eyes
|
|
Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle
Week 12
|
71.1 percentage of eyes
|
71.8 percentage of eyes
|
|
Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle
Week 15
|
65.3 percentage of eyes
|
61.2 percentage of eyes
|
|
Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle
Week 20
|
62.8 percentage of eyes
|
67.3 percentage of eyes
|
|
Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle
Week 24
|
73.2 percentage of eyes
|
75.2 percentage of eyes
|
|
Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle
Week 28
|
72.1 percentage of eyes
|
71.4 percentage of eyes
|
|
Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle
Week 31
|
67.5 percentage of eyes
|
62.1 percentage of eyes
|
|
Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle
Week 36
|
68.3 percentage of eyes
|
55.5 percentage of eyes
|
|
Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle
Week 40
|
72.1 percentage of eyes
|
62.0 percentage of eyes
|
|
Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle
Week 44
|
65.5 percentage of eyes
|
57.9 percentage of eyes
|
|
Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle
Week 47
|
83.3 percentage of eyes
|
70.9 percentage of eyes
|
|
Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle
Week 52
|
78.4 percentage of eyes
|
66.4 percentage of eyes
|
|
Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle
Month 13
|
73.1 percentage of eyes
|
65.7 percentage of eyes
|
|
Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle
Month 14
|
73.4 percentage of eyes
|
56.9 percentage of eyes
|
|
Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle
Month 15
|
72.0 percentage of eyes
|
61.2 percentage of eyes
|
|
Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle
Month 16
|
76.8 percentage of eyes
|
70.8 percentage of eyes
|
|
Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle
Month 18
|
75.0 percentage of eyes
|
60.3 percentage of eyes
|
|
Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle
Month 20
|
79.5 percentage of eyes
|
62.3 percentage of eyes
|
|
Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle
Month 22
|
78.6 percentage of eyes
|
69.1 percentage of eyes
|
|
Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle
Month 24
|
73.2 percentage of eyes
|
66.7 percentage of eyes
|
SECONDARY outcome
Timeframe: Baseline and Weeks 8, 15, and 20Population: Intent-to-treat poulation participants enrolled in Stage 2 with available IOP data at each time point.
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.
Outcome measures
| Measure |
Stage 2: SLT
n=183 Eyes
One 360° administration of SLT on Day 1 followed by up to two sham bimatoprost SR administrations.
|
Stage 2: Bimatoprost SR 10 µg
n=183 Eyes
Sham SLT on Day 1 followed by bimatoprost SR 10 µg administered on Day 4 with repeat administration at Week 16 or after Week 16 and prior to Month 12 depending on when retreatment criteria were met.
|
|---|---|---|
|
Change From Baseline in IOP at Weeks 8, 15, and 20
Baseline
|
25.1 mmHg
Standard Deviation 3.00
|
25.2 mmHg
Standard Deviation 2.99
|
|
Change From Baseline in IOP at Weeks 8, 15, and 20
Week 8
|
-6.1 mmHg
Standard Deviation 3.52
|
-6.8 mmHg
Standard Deviation 3.96
|
|
Change From Baseline in IOP at Weeks 8, 15, and 20
Week 15
|
-6.0 mmHg
Standard Deviation 3.58
|
-6.0 mmHg
Standard Deviation 4.36
|
|
Change From Baseline in IOP at Weeks 8, 15, and 20
Week 20
|
-5.9 mmHg
Standard Deviation 3.44
|
-6.4 mmHg
Standard Deviation 3.97
|
Adverse Events
Stage 1: SLT
Serious events: 3 serious events
Other events: 41 other events
Deaths: 0 deaths
Stage 1: Bimatoprost SR 15 µg
Serious events: 3 serious events
Other events: 49 other events
Deaths: 0 deaths
Stage 2: SLT
Serious events: 18 serious events
Other events: 107 other events
Deaths: 2 deaths
Stage 2: Bimatoprost SR 10 µg
Serious events: 22 serious events
Other events: 121 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Stage 1: SLT
n=56 participants at risk
Selective laser trabeculoplasty (SLT) administered on Day 1 followed by up to three sham bimatoprost SR administrations.
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).
|
Stage 1: Bimatoprost SR 15 µg
n=55 participants at risk
Sham SLT administered on Day 1 followed by up to three bimatoprost SR 15 µg administrations.
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).
|
Stage 2: SLT
n=180 participants at risk
SLT administered on Day 1 followed by up to two sham bimatoprost SR administrations.
Sham bimatoprost SR was administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2; participants who reached Week 32 prior to implementation of Protocol Amendment 3 only).
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.
|
Stage 2: Bimatoprost SR 10 µg
n=175 participants at risk
Sham SLT administered on Day 1 followed by up to two bimatoprost SR 10 µg administrations.
Bimatoprost SR was administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2; participants who reached Week 32 prior to implementation of Protocol Amendment 3 only).
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.
|
|---|---|---|---|---|
|
Cardiac disorders
ARTERIOSCLEROSIS CORONARY ARTERY
|
0.00%
0/56 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/55 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.56%
1/180 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.57%
1/175 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/56 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/55 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
1.1%
2/180 • Number of events 2 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
1.1%
2/175 • Number of events 2 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.00%
0/56 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/55 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.56%
1/180 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.57%
1/175 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
1.8%
1/56 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
1.8%
1/55 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/180 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/175 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Eye disorders
CATARACT SUBCAPSULAR
|
0.00%
0/56 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/55 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/180 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.57%
1/175 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Eye disorders
CORNEAL ENDOTHELIAL CELL LOSS
|
0.00%
0/56 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/55 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/180 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.57%
1/175 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Eye disorders
CORNEAL OEDEMA
|
0.00%
0/56 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
1.8%
1/55 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/180 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.57%
1/175 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Eye disorders
CORNEAL THICKENING
|
0.00%
0/56 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/55 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/180 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.57%
1/175 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Eye disorders
EPISCLERITIS
|
0.00%
0/56 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/55 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/180 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.57%
1/175 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Eye disorders
PHOTOPHOBIA
|
0.00%
0/56 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/55 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/180 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.57%
1/175 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Eye disorders
RETINAL VEIN OCCLUSION
|
1.8%
1/56 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/55 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/180 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/175 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Eye disorders
VISION BLURRED
|
0.00%
0/56 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/55 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/180 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.57%
1/175 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/56 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/55 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.56%
1/180 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.57%
1/175 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.00%
0/56 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/55 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.56%
1/180 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.57%
1/175 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.00%
0/56 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/55 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.56%
1/180 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.57%
1/175 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Infections and infestations
BURSITIS INFECTIVE
|
0.00%
0/56 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/55 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.56%
1/180 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.57%
1/175 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Infections and infestations
COVID-19
|
0.00%
0/56 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/55 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.56%
1/180 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.57%
1/175 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Infections and infestations
PNEUMONIA
|
1.8%
1/56 • Number of events 2 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
1.8%
1/55 • Number of events 2 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/180 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/175 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/56 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/55 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.56%
1/180 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.57%
1/175 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Musculoskeletal and connective tissue disorders
CERVICAL SPINAL STENOSIS
|
0.00%
0/56 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/55 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.56%
1/180 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.57%
1/175 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.00%
0/56 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/55 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.56%
1/180 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.57%
1/175 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
1.8%
1/56 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
1.8%
1/55 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.56%
1/180 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.57%
1/175 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Musculoskeletal and connective tissue disorders
SPINAL OSTEOARTHRITIS
|
0.00%
0/56 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/55 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.56%
1/180 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.57%
1/175 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA OF COLON
|
0.00%
0/56 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/55 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.56%
1/180 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.57%
1/175 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BLADDER CANCER
|
0.00%
0/56 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/55 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.56%
1/180 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.57%
1/175 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GASTRIC CANCER
|
0.00%
0/56 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/55 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.56%
1/180 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.57%
1/175 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OESOPHAGEAL CANCER METASTATIC
|
0.00%
0/56 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/55 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.56%
1/180 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.57%
1/175 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.00%
0/56 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/55 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.56%
1/180 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.57%
1/175 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER STAGE I
|
0.00%
0/56 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/55 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.56%
1/180 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.57%
1/175 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL CELL CARCINOMA
|
0.00%
0/56 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/55 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.56%
1/180 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.57%
1/175 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Nervous system disorders
APHASIA
|
0.00%
0/56 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/55 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.56%
1/180 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.57%
1/175 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Nervous system disorders
MYELOPATHY
|
0.00%
0/56 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/55 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.56%
1/180 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.57%
1/175 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.00%
0/56 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/55 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.56%
1/180 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.57%
1/175 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Respiratory, thoracic and mediastinal disorders
VOCAL CORD DISORDER
|
0.00%
0/56 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/55 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.56%
1/180 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.57%
1/175 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
0.00%
0/56 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/55 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.56%
1/180 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.57%
1/175 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Vascular disorders
ACCELERATED HYPERTENSION
|
0.00%
0/56 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/55 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.56%
1/180 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.57%
1/175 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/56 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/55 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.56%
1/180 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.57%
1/175 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
Other adverse events
| Measure |
Stage 1: SLT
n=56 participants at risk
Selective laser trabeculoplasty (SLT) administered on Day 1 followed by up to three sham bimatoprost SR administrations.
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).
|
Stage 1: Bimatoprost SR 15 µg
n=55 participants at risk
Sham SLT administered on Day 1 followed by up to three bimatoprost SR 15 µg administrations.
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).
|
Stage 2: SLT
n=180 participants at risk
SLT administered on Day 1 followed by up to two sham bimatoprost SR administrations.
Sham bimatoprost SR was administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2; participants who reached Week 32 prior to implementation of Protocol Amendment 3 only).
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.
|
Stage 2: Bimatoprost SR 10 µg
n=175 participants at risk
Sham SLT administered on Day 1 followed by up to two bimatoprost SR 10 µg administrations.
Bimatoprost SR was administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2; participants who reached Week 32 prior to implementation of Protocol Amendment 3 only).
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.
|
|---|---|---|---|---|
|
Eye disorders
ANTERIOR CHAMBER CELL
|
7.1%
4/56 • Number of events 4 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
10.9%
6/55 • Number of events 8 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
5.6%
10/180 • Number of events 10 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
4.0%
7/175 • Number of events 12 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Eye disorders
ANTERIOR CHAMBER FLARE
|
3.6%
2/56 • Number of events 2 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
7.3%
4/55 • Number of events 4 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.56%
1/180 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
1.7%
3/175 • Number of events 4 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Eye disorders
BLEPHARITIS
|
5.4%
3/56 • Number of events 3 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
3.6%
2/55 • Number of events 2 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
2.2%
4/180 • Number of events 4 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
1.7%
3/175 • Number of events 3 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Eye disorders
CONJUNCTIVAL HAEMORRHAGE
|
10.7%
6/56 • Number of events 6 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
18.2%
10/55 • Number of events 11 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
1.1%
2/180 • Number of events 2 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
5.1%
9/175 • Number of events 9 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Eye disorders
CONJUNCTIVAL HYPERAEMIA
|
23.2%
13/56 • Number of events 22 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
38.2%
21/55 • Number of events 47 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
12.2%
22/180 • Number of events 23 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
20.0%
35/175 • Number of events 48 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Eye disorders
CORNEAL ENDOTHELIAL CELL LOSS
|
7.1%
4/56 • Number of events 4 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
10.9%
6/55 • Number of events 6 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
3.3%
6/180 • Number of events 6 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
6.3%
11/175 • Number of events 13 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Eye disorders
CORNEAL TOUCH
|
0.00%
0/56 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
5.5%
3/55 • Number of events 3 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/180 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.57%
1/175 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Eye disorders
DRY EYE
|
8.9%
5/56 • Number of events 7 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
12.7%
7/55 • Number of events 10 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
12.2%
22/180 • Number of events 25 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
14.3%
25/175 • Number of events 34 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Eye disorders
EYE IRRITATION
|
7.1%
4/56 • Number of events 4 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
10.9%
6/55 • Number of events 6 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
1.1%
2/180 • Number of events 2 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
2.3%
4/175 • Number of events 4 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Eye disorders
EYE PAIN
|
10.7%
6/56 • Number of events 7 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
10.9%
6/55 • Number of events 11 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
2.2%
4/180 • Number of events 5 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
8.6%
15/175 • Number of events 19 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Eye disorders
FOREIGN BODY SENSATION IN EYES
|
1.8%
1/56 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
9.1%
5/55 • Number of events 5 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
1.1%
2/180 • Number of events 2 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
6.9%
12/175 • Number of events 14 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Eye disorders
IRITIS
|
0.00%
0/56 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
7.3%
4/55 • Number of events 4 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/180 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
2.9%
5/175 • Number of events 7 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Eye disorders
LACRIMATION INCREASED
|
5.4%
3/56 • Number of events 3 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
1.8%
1/55 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
1.7%
3/180 • Number of events 3 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
2.3%
4/175 • Number of events 5 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Eye disorders
PHOTOPHOBIA
|
1.8%
1/56 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
9.1%
5/55 • Number of events 8 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
1.1%
2/180 • Number of events 2 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
8.6%
15/175 • Number of events 23 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Eye disorders
PUNCTATE KERATITIS
|
8.9%
5/56 • Number of events 5 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
12.7%
7/55 • Number of events 9 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
10.6%
19/180 • Number of events 25 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
12.0%
21/175 • Number of events 27 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Eye disorders
VISION BLURRED
|
5.4%
3/56 • Number of events 3 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
7.3%
4/55 • Number of events 4 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
2.2%
4/180 • Number of events 4 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
3.4%
6/175 • Number of events 6 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Eye disorders
VISUAL FIELD DEFECT
|
0.00%
0/56 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
3.6%
2/55 • Number of events 2 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
10.0%
18/180 • Number of events 22 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
10.3%
18/175 • Number of events 20 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Eye disorders
VITREOUS FLOATERS
|
1.8%
1/56 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
5.5%
3/55 • Number of events 3 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.56%
1/180 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
1.1%
2/175 • Number of events 2 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Infections and infestations
BRONCHITIS
|
5.4%
3/56 • Number of events 3 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
5.5%
3/55 • Number of events 3 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.56%
1/180 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.57%
1/175 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Infections and infestations
COVID-19
|
0.00%
0/56 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/55 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
7.8%
14/180 • Number of events 15 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
8.0%
14/175 • Number of events 15 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Infections and infestations
CONJUNCTIVITIS
|
0.00%
0/56 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/55 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
2.8%
5/180 • Number of events 5 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
5.1%
9/175 • Number of events 10 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Infections and infestations
NASOPHARYNGITIS
|
5.4%
3/56 • Number of events 5 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
5.5%
3/55 • Number of events 5 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
4.4%
8/180 • Number of events 8 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
4.6%
8/175 • Number of events 8 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Investigations
INTRAOCULAR PRESSURE INCREASED
|
8.9%
5/56 • Number of events 6 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
14.5%
8/55 • Number of events 8 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
18.3%
33/180 • Number of events 41 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
24.6%
43/175 • Number of events 55 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
5.4%
3/56 • Number of events 3 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
5.5%
3/55 • Number of events 3 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/180 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
0.00%
0/175 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
5.4%
3/56 • Number of events 4 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
5.5%
3/55 • Number of events 4 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
1.1%
2/180 • Number of events 2 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
1.1%
2/175 • Number of events 2 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Nervous system disorders
HEADACHE
|
1.8%
1/56 • Number of events 1 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
3.6%
2/55 • Number of events 2 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
5.6%
10/180 • Number of events 10 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
5.7%
10/175 • Number of events 10 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
7.1%
4/56 • Number of events 5 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
7.3%
4/55 • Number of events 5 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
1.7%
3/180 • Number of events 3 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
1.7%
3/175 • Number of events 3 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
|
Vascular disorders
HYPERTENSION
|
7.1%
4/56 • Number of events 4 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
7.3%
4/55 • Number of events 4 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
8.3%
15/180 • Number of events 16 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
8.6%
15/175 • Number of events 16 • All-cause mortality (based on all randomized participants): for an overall median follow-up time of 728 days. Adverse events (AEs; based on all treated participants*): from first dose of study drug up to Month 24 ±7 days. *Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg); these participants are included only in the SLT reporting groups.
Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER