Trial Outcomes & Findings for A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension (NCT NCT02636946)
NCT ID: NCT02636946
Last Updated: 2022-02-23
Results Overview
IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
144 participants
Primary outcome timeframe
Baseline (prior to treatment)
Results posted on
2022-02-23
Participant Flow
A total of 144 participants were randomized with 72 participants in each treatment group. Out of them 142 participants were treated. The primary eye was defined as the eye with the higher intraocular pressure (IOP) at Baseline. If both the eyes were the same, the right eye was used as the primary eye. The contralateral eye is the other eye.
Participant milestones
| Measure |
SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye)
Primary Eye: Selective Laser Trabeculoplasty (SLT) administered on Day 1 followed by up to three Sham Bimatoprost sustained release (Bim SR) administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.
Contralateral (Other) Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants enrolled under Protocol Amendment 2 or later.
|
Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye)
Primary Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.
Contralateral (Other) Eye: SLT administered on Day 1 followed by up to three Sham Bimatoprost SR administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.
|
|---|---|---|
|
Cycle 1 (Day 1 to Week 15)
STARTED
|
72
|
72
|
|
Cycle 1 (Day 1 to Week 15)
Received Treatment in Either Eye
|
72
|
70
|
|
Cycle 1 (Day 1 to Week 15)
COMPLETED
|
71
|
67
|
|
Cycle 1 (Day 1 to Week 15)
NOT COMPLETED
|
1
|
5
|
|
Cycle 2 (Week 16 to Week 31)
STARTED
|
65
|
62
|
|
Cycle 2 (Week 16 to Week 31)
COMPLETED
|
63
|
61
|
|
Cycle 2 (Week 16 to Week 31)
NOT COMPLETED
|
2
|
1
|
|
Cycle 3 (Week 32 to Week 52)
STARTED
|
17
|
16
|
|
Cycle 3 (Week 32 to Week 52)
COMPLETED
|
17
|
16
|
|
Cycle 3 (Week 32 to Week 52)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye)
Primary Eye: Selective Laser Trabeculoplasty (SLT) administered on Day 1 followed by up to three Sham Bimatoprost sustained release (Bim SR) administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.
Contralateral (Other) Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants enrolled under Protocol Amendment 2 or later.
|
Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye)
Primary Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.
Contralateral (Other) Eye: SLT administered on Day 1 followed by up to three Sham Bimatoprost SR administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.
|
|---|---|---|
|
Cycle 1 (Day 1 to Week 15)
Withdrawal of Consent
|
0
|
1
|
|
Cycle 1 (Day 1 to Week 15)
Lost to Follow-up
|
1
|
0
|
|
Cycle 1 (Day 1 to Week 15)
Protocol Violation
|
0
|
1
|
|
Cycle 1 (Day 1 to Week 15)
Reason not Specified
|
0
|
1
|
|
Cycle 1 (Day 1 to Week 15)
Randomized but not Treated
|
0
|
2
|
|
Cycle 2 (Week 16 to Week 31)
Adverse Event
|
2
|
1
|
Baseline Characteristics
A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension
Baseline characteristics by cohort
| Measure |
SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye)
n=72 Participants
Primary Eye: Selective Laser Trabeculoplasty (SLT) administered on Day 1 followed by up to three Sham Bimatoprost sustained release (Bim SR) administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.
Contralateral (Other) Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants enrolled under Protocol Amendment 2 or later.
|
Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye)
n=72 Participants
Primary Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.
Contralateral (Other) Eye: SLT administered on Day 1 followed by up to three Sham Bimatoprost SR administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.
|
Total
n=144 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.9 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
62.1 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
60.0 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
53 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic
|
61 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (prior to treatment)Population: Modified Intent-to-Treat (mITT) Population was defined based in the Intent-to-Treat (ITT) population but excluded participants who did not receive the second implant after implementation of Amendment 3.
IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0.
Outcome measures
| Measure |
Selective Laser Trabeculoplasty
n=138 Participants
SLT administered on Day 1.
Participants' primary eyes from 'SLT (Primary Eye) / Bim SR 15 ug (Contralateral Eye)' arm and contralateral eyes from 'Bim SR 15 ug (Primary Eye) / SLT (Contralateral Eye)' arm were combined for outcome measure analyses.
|
Bim SR 15 μg
n=138 Participants
Three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.
Participants' contralateral eyes from 'SLT (Primary Eye) / Bim SR 15 ug (Contralateral Eye)' arm and primary eyes from 'Bim SR 15 ug (Primary Eye) / SLT (Contralateral Eye)' arm were combined for outcome measure analyses.
|
|---|---|---|
|
Intraocular Pressure (IOP) at Baseline
|
24.45 millimeters of mercury (mmHg)
Standard Deviation 2.75
|
24.38 millimeters of mercury (mmHg)
Standard Deviation 2.49
|
PRIMARY outcome
Timeframe: Baseline (prior to treatment) to Week 4Population: mITT Population was defined based in the ITT population but excluded participants who did not receive the second implant after implementation of Amendment 3. Overall number analyzed are number of participants and eyes with data available for analyses.
IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening. A mixed-effects model with repeated measures (MMRM) was used for analyses.
Outcome measures
| Measure |
Selective Laser Trabeculoplasty
n=131 eyes
SLT administered on Day 1.
Participants' primary eyes from 'SLT (Primary Eye) / Bim SR 15 ug (Contralateral Eye)' arm and contralateral eyes from 'Bim SR 15 ug (Primary Eye) / SLT (Contralateral Eye)' arm were combined for outcome measure analyses.
|
Bim SR 15 μg
n=135 eyes
Three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.
Participants' contralateral eyes from 'SLT (Primary Eye) / Bim SR 15 ug (Contralateral Eye)' arm and primary eyes from 'Bim SR 15 ug (Primary Eye) / SLT (Contralateral Eye)' arm were combined for outcome measure analyses.
|
|---|---|---|
|
Change From Baseline in IOP at Week 4
|
-6.28 mmHg
Standard Error 0.30
|
-6.98 mmHg
Standard Error 0.29
|
PRIMARY outcome
Timeframe: Baseline (prior to treatment) to Week 12Population: mITT Population was defined based in the ITT population but excluded participants who did not receive the second implant after implementation of Amendment 3. Overall number analyzed are number of participants and eyes with data available for analyses.
IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening. A MMRM was used for analyses.
Outcome measures
| Measure |
Selective Laser Trabeculoplasty
n=122 eyes
SLT administered on Day 1.
Participants' primary eyes from 'SLT (Primary Eye) / Bim SR 15 ug (Contralateral Eye)' arm and contralateral eyes from 'Bim SR 15 ug (Primary Eye) / SLT (Contralateral Eye)' arm were combined for outcome measure analyses.
|
Bim SR 15 μg
n=128 eyes
Three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.
Participants' contralateral eyes from 'SLT (Primary Eye) / Bim SR 15 ug (Contralateral Eye)' arm and primary eyes from 'Bim SR 15 ug (Primary Eye) / SLT (Contralateral Eye)' arm were combined for outcome measure analyses.
|
|---|---|---|
|
Change From Baseline in IOP at Week 12
|
-6.28 mmHg
Standard Error 0.29
|
-6.81 mmHg
Standard Error 0.29
|
PRIMARY outcome
Timeframe: Baseline (prior to treatment) to Week 24Population: mITT Population was defined based in the ITT population but excluded participants who did not receive the second implant after implementation of Amendment 3. Overall number analyzed are number of participants and eyes with data available for analyses.
IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening. A MMRM was used for analyses.
Outcome measures
| Measure |
Selective Laser Trabeculoplasty
n=117 eyes
SLT administered on Day 1.
Participants' primary eyes from 'SLT (Primary Eye) / Bim SR 15 ug (Contralateral Eye)' arm and contralateral eyes from 'Bim SR 15 ug (Primary Eye) / SLT (Contralateral Eye)' arm were combined for outcome measure analyses.
|
Bim SR 15 μg
n=126 eyes
Three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.
Participants' contralateral eyes from 'SLT (Primary Eye) / Bim SR 15 ug (Contralateral Eye)' arm and primary eyes from 'Bim SR 15 ug (Primary Eye) / SLT (Contralateral Eye)' arm were combined for outcome measure analyses.
|
|---|---|---|
|
Change From Baseline in Intraocular Pressure (IOP) at Week 24
|
-6.34 mmHg
Standard Error 0.29
|
-6.59 mmHg
Standard Error 0.29
|
SECONDARY outcome
Timeframe: Baseline (prior to treatment) to Weeks 8, 15 and 20Population: ITT Population was defined as all randomized participants. Number analyzed is the number of participants and eyes analyzed at the given timepoint.
IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening.
Outcome measures
| Measure |
Selective Laser Trabeculoplasty
n=144 eyes
SLT administered on Day 1.
Participants' primary eyes from 'SLT (Primary Eye) / Bim SR 15 ug (Contralateral Eye)' arm and contralateral eyes from 'Bim SR 15 ug (Primary Eye) / SLT (Contralateral Eye)' arm were combined for outcome measure analyses.
|
Bim SR 15 μg
n=144 eyes
Three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.
Participants' contralateral eyes from 'SLT (Primary Eye) / Bim SR 15 ug (Contralateral Eye)' arm and primary eyes from 'Bim SR 15 ug (Primary Eye) / SLT (Contralateral Eye)' arm were combined for outcome measure analyses.
|
|---|---|---|
|
Change From Baseline in IOP at Weeks 8, 15, and 20
Change from Baseline at Week 8
|
-6.65 mmHg
Standard Deviation 3.10
|
-7.09 mmHg
Standard Deviation 2.93
|
|
Change From Baseline in IOP at Weeks 8, 15, and 20
Change from Baseline at Week 15
|
-6.14 mmHg
Standard Deviation 3.47
|
-5.36 mmHg
Standard Deviation 3.73
|
|
Change From Baseline in IOP at Weeks 8, 15, and 20
Change from Baseline at Week 20
|
-5.06 mmHg
Standard Deviation 3.33
|
-4.29 mmHg
Standard Deviation 1.93
|
SECONDARY outcome
Timeframe: First treatment to end of study (up to 525 days)Population: ITT Population was defined as all randomized participants. Overall number analyzed are number of participants and eyes with data available for analyses.
Median time in days from first treatment to the initial use of non-study IOP-lowering treatment.
Outcome measures
| Measure |
Selective Laser Trabeculoplasty
n=142 eyes
SLT administered on Day 1.
Participants' primary eyes from 'SLT (Primary Eye) / Bim SR 15 ug (Contralateral Eye)' arm and contralateral eyes from 'Bim SR 15 ug (Primary Eye) / SLT (Contralateral Eye)' arm were combined for outcome measure analyses.
|
Bim SR 15 μg
n=141 eyes
Three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.
Participants' contralateral eyes from 'SLT (Primary Eye) / Bim SR 15 ug (Contralateral Eye)' arm and primary eyes from 'Bim SR 15 ug (Primary Eye) / SLT (Contralateral Eye)' arm were combined for outcome measure analyses.
|
|---|---|---|
|
Time to Initial Use of Nonstudy IOP-lowering Treatment as Determined by the Investigator
|
410 days
Interval 392.0 to
The upper limit of 95% confidence interval was not estimable due to the low number of participants with events.
|
446 days
Interval 407.0 to
The upper limit of 95% confidence interval was not estimable due to the low number of participants with events.
|
SECONDARY outcome
Timeframe: Baseline (prior to treatment) to Cycle 1: Day 2, Weeks 4, 8, 12, 15, 20, 24, 28, 31, 36, 40, 44, 47, 52; Cycle 2:Day 2, Weeks 4, 8, 12, 15, 20, 24, 28, 31, 36; Cycle 3: Day 2, Weeks 4, 8, 15, 20Population: ITT Population was defined as all randomized participants. Number analyzed is number of participants and eyes analyzed at the given timepoint.
IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. The participants who did not continue in the subsequent cycle were followed up to Week 52 in Cycle 1, Week 36 in Cycle 2, and Week 20 in Cycle 3.
Outcome measures
| Measure |
Selective Laser Trabeculoplasty
n=144 eyes
SLT administered on Day 1.
Participants' primary eyes from 'SLT (Primary Eye) / Bim SR 15 ug (Contralateral Eye)' arm and contralateral eyes from 'Bim SR 15 ug (Primary Eye) / SLT (Contralateral Eye)' arm were combined for outcome measure analyses.
|
Bim SR 15 μg
n=144 eyes
Three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.
Participants' contralateral eyes from 'SLT (Primary Eye) / Bim SR 15 ug (Contralateral Eye)' arm and primary eyes from 'Bim SR 15 ug (Primary Eye) / SLT (Contralateral Eye)' arm were combined for outcome measure analyses.
|
|---|---|---|
|
Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP
Cycle 3 Day 2
|
75.8 percentage of participants
|
90.9 percentage of participants
|
|
Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP
Cycle 1 Day 2
|
60.6 percentage of participants
|
92.7 percentage of participants
|
|
Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP
Cycle 1 Week 4
|
70.2 percentage of participants
|
78.0 percentage of participants
|
|
Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP
Cycle 1 Week 8
|
72.9 percentage of participants
|
80.0 percentage of participants
|
|
Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP
Cycle 1 Week 12
|
67.9 percentage of participants
|
75.2 percentage of participants
|
|
Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP
Cycle 1 Week 15
|
67.2 percentage of participants
|
64.2 percentage of participants
|
|
Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP
Cycle 1 Week 20
|
50.0 percentage of participants
|
40.0 percentage of participants
|
|
Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP
Cycle 1 Week 24
|
81.8 percentage of participants
|
45.5 percentage of participants
|
|
Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP
Cycle 1 Week 28
|
63.6 percentage of participants
|
45.5 percentage of participants
|
|
Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP
Cycle 1 Week 31
|
100.0 percentage of participants
|
40.0 percentage of participants
|
|
Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP
Cycle 1 Week 36
|
72.7 percentage of participants
|
72.7 percentage of participants
|
|
Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP
Cycle 1 Week 40
|
54.5 percentage of participants
|
54.5 percentage of participants
|
|
Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP
Cycle 1 Week 44
|
81.8 percentage of participants
|
45.5 percentage of participants
|
|
Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP
Cycle 1 Week 47
|
72.7 percentage of participants
|
54.5 percentage of participants
|
|
Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP
Cycle 1 Week 52
|
81.8 percentage of participants
|
81.8 percentage of participants
|
|
Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP
Cycle 2 Day 2
|
70.2 percentage of participants
|
89.5 percentage of participants
|
|
Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP
Cycle 2 Week 4
|
68.8 percentage of participants
|
75.2 percentage of participants
|
|
Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP
Cycle 2 Week 8
|
68.5 percentage of participants
|
71.0 percentage of participants
|
|
Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP
Cycle 2 Week 12
|
72.0 percentage of participants
|
65.3 percentage of participants
|
|
Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP
Cycle 2 Week 15
|
69.4 percentage of participants
|
64.3 percentage of participants
|
|
Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP
Cycle 2 Week 20
|
76.9 percentage of participants
|
64.8 percentage of participants
|
|
Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP
Cycle 2 Week 24
|
64.4 percentage of participants
|
71.3 percentage of participants
|
|
Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP
Cycle 2 Week 28
|
76.5 percentage of participants
|
74.1 percentage of participants
|
|
Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP
Cycle 2 Week 31
|
76.7 percentage of participants
|
74.4 percentage of participants
|
|
Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP
Cycle 2 Week 36
|
79.1 percentage of participants
|
67.0 percentage of participants
|
|
Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP
Cycle 3 Week 4
|
74.2 percentage of participants
|
71.0 percentage of participants
|
|
Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP
Cycle 3 Week 8
|
75.0 percentage of participants
|
59.4 percentage of participants
|
|
Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP
Cycle 3 Week 15
|
70.0 percentage of participants
|
43.3 percentage of participants
|
|
Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP
Cycle 3 Week 20
|
69.7 percentage of participants
|
39.4 percentage of participants
|
Adverse Events
SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye)
Serious events: 11 serious events
Other events: 56 other events
Deaths: 0 deaths
Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye)
Serious events: 6 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye)
n=72 participants at risk
Primary Eye: Selective Laser Trabeculoplasty (SLT) administered on Day 1 followed by up to three Sham Bimatoprost sustained release (Bim SR) administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.
Contralateral (Other) Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants enrolled under Protocol Amendment 2 or later.
|
Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye)
n=70 participants at risk
Primary Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.
Contralateral (Other) Eye: SLT administered on Day 1 followed by up to three Sham Bimatoprost SR administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
1.4%
1/72 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
0.00%
0/70 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
|
Eye disorders
Corneal endothelial cell loss
|
5.6%
4/72 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
1.4%
1/70 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
|
Eye disorders
Cataract
|
1.4%
1/72 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
0.00%
0/70 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
|
Eye disorders
Corneal oedema
|
0.00%
0/72 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
2.9%
2/70 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
|
Immune system disorders
Drug hypersensitivity
|
1.4%
1/72 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
0.00%
0/70 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
|
Infections and infestations
COVID-19 pneumonia
|
1.4%
1/72 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
0.00%
0/70 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
1.4%
1/72 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
0.00%
0/70 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
1.4%
1/72 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
0.00%
0/70 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
1.4%
1/72 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
0.00%
0/70 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
1.4%
1/72 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
0.00%
0/70 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
|
Nervous system disorders
Quadrantanopia
|
1.4%
1/72 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
0.00%
0/70 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/72 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
1.4%
1/70 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/72 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
1.4%
1/70 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/72 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
1.4%
1/70 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
|
Renal and urinary disorders
Renal haematoma
|
0.00%
0/72 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
1.4%
1/70 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
|
Renal and urinary disorders
Renal haemorrhage
|
0.00%
0/72 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
1.4%
1/70 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.00%
0/72 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
1.4%
1/70 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/72 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
1.4%
1/70 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
Other adverse events
| Measure |
SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye)
n=72 participants at risk
Primary Eye: Selective Laser Trabeculoplasty (SLT) administered on Day 1 followed by up to three Sham Bimatoprost sustained release (Bim SR) administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.
Contralateral (Other) Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants enrolled under Protocol Amendment 2 or later.
|
Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye)
n=70 participants at risk
Primary Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.
Contralateral (Other) Eye: SLT administered on Day 1 followed by up to three Sham Bimatoprost SR administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.
|
|---|---|---|
|
Eye disorders
Conjunctival hyperaemia
|
41.7%
30/72 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
27.1%
19/70 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
|
Eye disorders
Corneal endothelial cell loss
|
15.3%
11/72 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
5.7%
4/70 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
|
Eye disorders
Punctate keratitis
|
13.9%
10/72 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
11.4%
8/70 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
|
Eye disorders
Conjunctival haemorrhage
|
9.7%
7/72 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
7.1%
5/70 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
|
Eye disorders
Corneal oedema
|
8.3%
6/72 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
12.9%
9/70 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
|
Eye disorders
Photophobia
|
8.3%
6/72 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
5.7%
4/70 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
|
Eye disorders
Eye irritation
|
8.3%
6/72 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
4.3%
3/70 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
|
Eye disorders
Eye pain
|
6.9%
5/72 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
12.9%
9/70 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
|
Eye disorders
Dry eye
|
6.9%
5/72 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
4.3%
3/70 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
|
Eye disorders
Anterior chamber cell
|
5.6%
4/72 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
4.3%
3/70 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
|
Eye disorders
Foreign body sensation in eyes
|
5.6%
4/72 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
4.3%
3/70 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
|
Eye disorders
Corneal opacity
|
5.6%
4/72 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
0.00%
0/70 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
|
Infections and infestations
Conjunctivitis
|
5.6%
4/72 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
1.4%
1/70 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
|
Infections and infestations
Sinusitis
|
1.4%
1/72 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
5.7%
4/70 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
|
Investigations
Intraocular pressure increased
|
18.1%
13/72 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
10.0%
7/70 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/72 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
5.7%
4/70 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
|
Nervous system disorders
Headache
|
4.2%
3/72 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
5.7%
4/70 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
|
Vascular disorders
Hypertension
|
2.8%
2/72 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
8.6%
6/70 • First treatment to end of study (up to 525 days)
All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
|
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