Trial Outcomes & Findings for Dose-Ranging Study of the Bimatoprost Ocular Insert (NCT NCT02358369)
NCT ID: NCT02358369
Last Updated: 2020-06-04
Results Overview
IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 8. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated an improvement.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
156 participants
Primary outcome timeframe
Baseline (Day 0) to Week 8
Results posted on
2020-06-04
Participant Flow
156 participants were enrolled and entered the washout placebo and trial-wear period. A total of 121 participants were randomized to one of three treatment groups.
Participant milestones
| Measure |
Washout + Placebo Ocular Insert
Glaucoma medication washout and placebo ocular insert in each eye for 4 to 6 weeks prior to randomization.
|
Placebo Ocular Insert + Timolol 0.5% (Period A/B)
Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular insert in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued.
|
2.2 mg Bimatoprost Ocular Insert (Period A/B)
Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.
|
13 mg Bimatoprost Ocular Insert (Period A/B)
Following the washout period, 13 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops to each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 13 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.
|
13 mg Bimatoprost Ocular Insert (Period C)
Following Treatment Period A/B, 13 mg Bimatoprost Ocular Insert for 12 weeks in Period C (Week 12 to 24).
|
|---|---|---|---|---|---|
|
Pre-Randomization Washout Period
STARTED
|
156
|
0
|
0
|
0
|
0
|
|
Pre-Randomization Washout Period
COMPLETED
|
121
|
0
|
0
|
0
|
0
|
|
Pre-Randomization Washout Period
NOT COMPLETED
|
35
|
0
|
0
|
0
|
0
|
|
Treatment Period A/B
STARTED
|
0
|
40
|
40
|
41
|
0
|
|
Treatment Period A/B
COMPLETED
|
0
|
38
|
38
|
37
|
0
|
|
Treatment Period A/B
NOT COMPLETED
|
0
|
2
|
2
|
4
|
0
|
|
Treatment Period C
STARTED
|
0
|
0
|
0
|
0
|
113
|
|
Treatment Period C
COMPLETED
|
0
|
0
|
0
|
0
|
106
|
|
Treatment Period C
NOT COMPLETED
|
0
|
0
|
0
|
0
|
7
|
Reasons for withdrawal
| Measure |
Washout + Placebo Ocular Insert
Glaucoma medication washout and placebo ocular insert in each eye for 4 to 6 weeks prior to randomization.
|
Placebo Ocular Insert + Timolol 0.5% (Period A/B)
Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular insert in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued.
|
2.2 mg Bimatoprost Ocular Insert (Period A/B)
Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.
|
13 mg Bimatoprost Ocular Insert (Period A/B)
Following the washout period, 13 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops to each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 13 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.
|
13 mg Bimatoprost Ocular Insert (Period C)
Following Treatment Period A/B, 13 mg Bimatoprost Ocular Insert for 12 weeks in Period C (Week 12 to 24).
|
|---|---|---|---|---|---|
|
Pre-Randomization Washout Period
Not Qualified for Randomization
|
35
|
0
|
0
|
0
|
0
|
|
Treatment Period A/B
Adverse Event
|
0
|
0
|
1
|
2
|
0
|
|
Treatment Period A/B
Death
|
0
|
0
|
1
|
0
|
0
|
|
Treatment Period A/B
Withdrawal by Subject
|
0
|
2
|
0
|
2
|
0
|
|
Treatment Period C
Adverse Event
|
0
|
0
|
0
|
0
|
7
|
Baseline Characteristics
Dose-Ranging Study of the Bimatoprost Ocular Insert
Baseline characteristics by cohort
| Measure |
Placebo Ocular Insert + Timolol 0.5%
n=40 Participants
Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular inserts in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued. In Treatment Period C all participants were fitted with 13 mg Bimatoprost Ocular Inserts for 12 weeks.
|
2.2 mg Bimatoprost Ocular Insert
n=40 Participants
Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued. In Treatment Period C all participants were fitted with 13 mg Bimatoprost Ocular Insert in each eye for 12 weeks.
|
13 mg Bimatoprost Ocular Insert
n=41 Participants
Following the washout period, 13 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 13 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued. In Treatment Period C all participants were fitted with 13 mg Bimatoprost Ocular Insert in each eye for 12 weeks.
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
67.7 years
STANDARD_DEVIATION 8.70 • n=5 Participants
|
64.1 years
STANDARD_DEVIATION 9.24 • n=7 Participants
|
63.0 years
STANDARD_DEVIATION 10.01 • n=5 Participants
|
64.9 years
STANDARD_DEVIATION 9.47 • n=4 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0) to Week 8Population: Participants from the FAS, all participants who were randomized, treated and returned for at least one post-treatment visit, with data available at Week 8.
IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 8. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated an improvement.
Outcome measures
| Measure |
Placebo Ocular Insert + Timolol 0.5% (Period A/B)
n=38 Participants
Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular insert in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued.
|
2.2 mg Bimatoprost Ocular Insert (Period A/B)
n=35 Participants
Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.
|
13 mg Bimatoprost Ocular Insert (Period A/B)
n=36 Participants
Following the washout period, 13 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops to each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 13 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.
|
|---|---|---|---|
|
Change From Baseline in Intraocular Pressure (IOP) at Week 8
Change from Baseline to Week 8 (T=0 hour)
|
-4.68 mm Hg
Standard Deviation 2.931
|
-3.68 mm Hg
Standard Deviation 3.105
|
-4.56 mm Hg
Standard Deviation 3.007
|
|
Change From Baseline in Intraocular Pressure (IOP) at Week 8
Change from Baseline to Week 8 (T=2 hour)
|
-3.62 mm Hg
Standard Deviation 2.924
|
-3.31 mm Hg
Standard Deviation 3.063
|
-3.98 mm Hg
Standard Deviation 3.522
|
|
Change From Baseline in Intraocular Pressure (IOP) at Week 8
Change from Baseline to Week 8 (T=8 hour)
|
-3.21 mm Hg
Standard Deviation 2.812
|
-3.23 mm Hg
Standard Deviation 2.573
|
-3.22 mm Hg
Standard Deviation 3.061
|
PRIMARY outcome
Timeframe: Baseline (Day 0) to Week 12Population: FAS, all participants who were randomized, treated and returned for at least one post-treatment visit, with data available at Week 12. Participants on rescue therapy with missing data during the evaluation period or measurements out of the pre-specified visit window had IOP data imputed using LOCF (last observation carried forward) for the visit.
IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 12. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated an improvement.
Outcome measures
| Measure |
Placebo Ocular Insert + Timolol 0.5% (Period A/B)
n=38 Participants
Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular insert in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued.
|
2.2 mg Bimatoprost Ocular Insert (Period A/B)
n=35 Participants
Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.
|
13 mg Bimatoprost Ocular Insert (Period A/B)
n=37 Participants
Following the washout period, 13 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops to each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 13 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.
|
|---|---|---|---|
|
Change From Baseline in IOP at Week 12
Change from Baseline to Week 12 (T=0 hour)
|
-3.37 mm Hg
Standard Deviation 3.147
|
-3.64 mm Hg
Standard Deviation 3.454
|
-4.08 mm Hg
Standard Deviation 2.893
|
|
Change From Baseline in IOP at Week 12
Change from Baseline to Week 12 (T=2 hour)
|
-2.74 mm Hg
Standard Deviation 2.891
|
-3.67 mm Hg
Standard Deviation 3.182
|
-3.40 mm Hg
Standard Deviation 3.815
|
|
Change From Baseline in IOP at Week 12
Change from Baseline to Week 12 (T=8 hour)
|
-2.34 mm Hg
Standard Deviation 2.756
|
-3.20 mm Hg
Standard Deviation 2.491
|
-2.69 mm Hg
Standard Deviation 2.523
|
PRIMARY outcome
Timeframe: Baseline (Day 0) to Week 8Population: Participants from the Safety Population, all randomized participants who had an ocular insert placed, with data available for analysis at Week 8.
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Outcome measures
| Measure |
Placebo Ocular Insert + Timolol 0.5% (Period A/B)
n=38 Participants
Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular insert in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued.
|
2.2 mg Bimatoprost Ocular Insert (Period A/B)
n=39 Participants
Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.
|
13 mg Bimatoprost Ocular Insert (Period A/B)
n=36 Participants
Following the washout period, 13 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops to each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 13 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.
|
|---|---|---|---|
|
Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8
Right Eye, 10+ Letter Improvement
|
2.6 percentage of participants
|
0 percentage of participants
|
2.8 percentage of participants
|
|
Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8
Right Eye, 5+ Letter Improvement
|
18.4 percentage of participants
|
7.7 percentage of participants
|
5.6 percentage of participants
|
|
Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8
Right Eye, No Change
|
65.8 percentage of participants
|
69.2 percentage of participants
|
77.8 percentage of participants
|
|
Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8
Right Eye, 5- Letter Worsening
|
13.2 percentage of participants
|
17.9 percentage of participants
|
13.9 percentage of participants
|
|
Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8
Right Eye, 10- Letter Worsening
|
0 percentage of participants
|
5.1 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8
Left Eye, 10+ Letter Improvement
|
2.6 percentage of participants
|
0 percentage of participants
|
5.6 percentage of participants
|
|
Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8
Left Eye, 5+ Letter Improvement
|
10.5 percentage of participants
|
20.5 percentage of participants
|
19.4 percentage of participants
|
|
Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8
Left Eye, No Change
|
68.4 percentage of participants
|
66.7 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8
Left Eye, 5- Letter Worsening
|
15.8 percentage of participants
|
7.7 percentage of participants
|
5.6 percentage of participants
|
|
Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8
Left Eye, 10- Letter Worsening
|
2.6 percentage of participants
|
5.1 percentage of participants
|
2.8 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0) to Week 12Population: Participants from the Safety Population, all randomized participants who had an ocular insert placed, with data available for analysis at Week 12.
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Outcome measures
| Measure |
Placebo Ocular Insert + Timolol 0.5% (Period A/B)
n=38 Participants
Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular insert in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued.
|
2.2 mg Bimatoprost Ocular Insert (Period A/B)
n=38 Participants
Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.
|
13 mg Bimatoprost Ocular Insert (Period A/B)
n=36 Participants
Following the washout period, 13 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops to each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 13 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.
|
|---|---|---|---|
|
Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12
Right Eye, 10+ Letter Improvement
|
0 percentage of participants
|
0 percentage of participants
|
2.8 percentage of participants
|
|
Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12
Right Eye, 5+ Letter Improvement
|
7.9 percentage of participants
|
5.3 percentage of participants
|
11.1 percentage of participants
|
|
Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12
Right Eye, No Change
|
73.7 percentage of participants
|
57.9 percentage of participants
|
61.1 percentage of participants
|
|
Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12
Right Eye, 5- Letter Worsening
|
13.2 percentage of participants
|
28.9 percentage of participants
|
22.2 percentage of participants
|
|
Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12
Right Eye, 10- Letter Worsening
|
5.3 percentage of participants
|
7.9 percentage of participants
|
2.8 percentage of participants
|
|
Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12
Left Eye, 10+ Letter Improvement
|
0 percentage of participants
|
0 percentage of participants
|
5.6 percentage of participants
|
|
Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12
Left Eye, 5+ Letter Improvement
|
7.9 percentage of participants
|
13.2 percentage of participants
|
19.4 percentage of participants
|
|
Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12
Left Eye, No Change
|
71.1 percentage of participants
|
68.4 percentage of participants
|
61.1 percentage of participants
|
|
Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12
Left Eye, 5- Letter Worsening
|
18.4 percentage of participants
|
15.8 percentage of participants
|
13.9 percentage of participants
|
|
Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12
Left Eye, 10- Letter Worsening
|
2.6 percentage of participants
|
2.6 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0) to Week 12Population: Safety population included all participants who had an ocular insert placed.
The clinician examined and graded the eyelids, conjunctiva, cornea and anterior chamber of the eye with the aid of a slit-lamp, (conjunctival erythema was assessed as part of the examination). Fluorescein dye was instilled into the ocular cul-de-sac to facilitate this examination.
Outcome measures
| Measure |
Placebo Ocular Insert + Timolol 0.5% (Period A/B)
n=40 Participants
Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular insert in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued.
|
2.2 mg Bimatoprost Ocular Insert (Period A/B)
n=40 Participants
Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.
|
13 mg Bimatoprost Ocular Insert (Period A/B)
n=41 Participants
Following the washout period, 13 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops to each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 13 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.
|
|---|---|---|---|
|
Percentage of Participants With Clinically Significant Change From Baseline in Slit-Lamp Examination Findings at Week 12
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0) to Week 12Population: Safety Population included all randomized participants who had an ocular insert placed. The number of participants analyzed is the number of participants with data available at the given time-point.
Automated Visual Field was examined used the Humphrey Visual Field Analyzer, a test that measures the entire area of peripheral vision that can be seen while the eye is focused on a central point. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Placebo Ocular Insert + Timolol 0.5% (Period A/B)
n=40 Participants
Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular insert in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued.
|
2.2 mg Bimatoprost Ocular Insert (Period A/B)
n=40 Participants
Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.
|
13 mg Bimatoprost Ocular Insert (Period A/B)
n=41 Participants
Following the washout period, 13 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops to each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 13 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.
|
|---|---|---|---|
|
Change From Baseline in Automated Visual Field at Week 12
Baseline
|
-2.58 decibels (dB)
Standard Deviation 3.377
|
-1.45 decibels (dB)
Standard Deviation 4.041
|
-2.70 decibels (dB)
Standard Deviation 2.934
|
|
Change From Baseline in Automated Visual Field at Week 12
Change from Baseline to Week 12
|
-0.18 decibels (dB)
Standard Deviation 2.010
|
0.02 decibels (dB)
Standard Deviation 1.819
|
0.39 decibels (dB)
Standard Deviation 1.446
|
PRIMARY outcome
Timeframe: Week 12Population: Participants from the Safety Population, all randomized participants who had an ocular insert placed, with data available for analysis. The number analyzed is the number of participants with data available at the given time-point.
The cup-to-disk-ratio is an eye test to assess the progression of glaucoma. The diameter of the cup is compared to the diameter of the disk and a ratio is determined. The normal cup-disk ratio is 0.3. An increase in the cup-to-disc-ratio is a possible indication of glaucoma.
Outcome measures
| Measure |
Placebo Ocular Insert + Timolol 0.5% (Period A/B)
n=38 Participants
Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular insert in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued.
|
2.2 mg Bimatoprost Ocular Insert (Period A/B)
n=38 Participants
Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.
|
13 mg Bimatoprost Ocular Insert (Period A/B)
n=36 Participants
Following the washout period, 13 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops to each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 13 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.
|
|---|---|---|---|
|
Dilated Fundus Exam: Cup-to-Disc-Ratio
Right Eye, Week 12
|
0.53 ratio
Standard Deviation 0.172
|
0.55 ratio
Standard Deviation 0.161
|
0.47 ratio
Standard Deviation 0.184
|
|
Dilated Fundus Exam: Cup-to-Disc-Ratio
Left Eye, Week 12
|
0.54 ratio
Standard Deviation 0.160
|
0.56 ratio
Standard Deviation 0.157
|
0.48 ratio
Standard Deviation 0.176
|
PRIMARY outcome
Timeframe: Week 12Population: Safety Population included all randomized participants who had an ocular insert placed. The number of participants analyzed is the number of participants with data available at the given time-point.
Dilated fundus examination pathology findings were noted, described and graded on a scale of None (0), Mild (+1), Moderate (+2) and Severe (+3). The percentage of participants in each grade is reported.
Outcome measures
| Measure |
Placebo Ocular Insert + Timolol 0.5% (Period A/B)
n=40 Participants
Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular insert in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued.
|
2.2 mg Bimatoprost Ocular Insert (Period A/B)
n=40 Participants
Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.
|
13 mg Bimatoprost Ocular Insert (Period A/B)
n=41 Participants
Following the washout period, 13 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops to each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 13 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.
|
|---|---|---|---|
|
Percentage of Participants by Dilated Fundus Exam Pathology Grade at Week 12
Right Eye, None
|
63.2 percentage of participants
|
71.1 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants by Dilated Fundus Exam Pathology Grade at Week 12
Left Eye, None
|
62.2 percentage of participants
|
71.1 percentage of participants
|
47.2 percentage of participants
|
|
Percentage of Participants by Dilated Fundus Exam Pathology Grade at Week 12
Right Eye, Mild
|
34.2 percentage of participants
|
26.3 percentage of participants
|
44.4 percentage of participants
|
|
Percentage of Participants by Dilated Fundus Exam Pathology Grade at Week 12
Left Eye, Mild
|
35.1 percentage of participants
|
26.3 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants by Dilated Fundus Exam Pathology Grade at Week 12
Right Eye, Moderate
|
2.6 percentage of participants
|
2.6 percentage of participants
|
5.6 percentage of participants
|
|
Percentage of Participants by Dilated Fundus Exam Pathology Grade at Week 12
Left Eye, Moderate
|
2.7 percentage of participants
|
2.6 percentage of participants
|
2.8 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0) to Week 12Population: Safety Population included all randomized participants who had an ocular insert placed.
An AE was defined as any untoward medical occurrence (eg, sign, symptom, disease, syndrome, intercurrent illness) that occurred in a study participant, regardless of the suspected cause during the study. An ocular AE is an AE that occurred in the eye and non-ocular is an AE that occurred not in the eye. Th investigator assessed the worst severity of each AE as: Mild=aware of sign or symptom, but readily tolerated, Moderate=discomfort enough to cause interference with usual activity or Severe=incapacitating with inability to work or do usual activity.
Outcome measures
| Measure |
Placebo Ocular Insert + Timolol 0.5% (Period A/B)
n=40 Participants
Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular insert in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued.
|
2.2 mg Bimatoprost Ocular Insert (Period A/B)
n=40 Participants
Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.
|
13 mg Bimatoprost Ocular Insert (Period A/B)
n=41 Participants
Following the washout period, 13 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops to each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 13 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.
|
|---|---|---|---|
|
Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period A/B
Ocular, Mild
|
12.5 percentage of participants
|
17.5 percentage of participants
|
26.8 percentage of participants
|
|
Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period A/B
Ocular, Moderate
|
2.5 percentage of participants
|
5.0 percentage of participants
|
4.9 percentage of participants
|
|
Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period A/B
Ocular, Severe
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period A/B
Non-ocular, Mild
|
5.0 percentage of participants
|
5.0 percentage of participants
|
9.8 percentage of participants
|
|
Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period A/B
Non-Ocular, Moderate
|
15.0 percentage of participants
|
2.5 percentage of participants
|
7.3 percentage of participants
|
|
Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period A/B
Non-ocular, Severe
|
0 percentage of participants
|
2.5 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Week 12 to Week 24Population: Safety Population included all randomized participants who had an ocular insert placed.
An AE was defined as any untoward medical occurrence (eg, sign, symptom, disease, syndrome, intercurrent illness) that occurred in a study participant, regardless of the suspected cause during the study. An ocular AE is an AE that occurred in the eye and non-ocular is an AE that occurred not in the eye. The investigator assessed the worst severity of each AE as: Mild=aware of sign or symptom, but readily tolerated, Moderate=discomfort enough to cause interference with usual activity or Severe=incapacitating with inability to work or do usual activity.
Outcome measures
| Measure |
Placebo Ocular Insert + Timolol 0.5% (Period A/B)
n=113 Participants
Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular insert in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued.
|
2.2 mg Bimatoprost Ocular Insert (Period A/B)
Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.
|
13 mg Bimatoprost Ocular Insert (Period A/B)
Following the washout period, 13 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops to each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 13 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.
|
|---|---|---|---|
|
Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period C
Ocular, Mild
|
23.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period C
Ocular, Moderate
|
5.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period C
Ocular, Severe
|
0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period C
Non-ocular, Mild
|
5.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period C
Non-ocular, Moderate
|
4.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period C
Non-ocular, Severe
|
0.9 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 0) to Week 2Population: Participants from the FAS, all participants who were randomized, treated and returned for at least one post-treatment visit, with data available at Week 2.
IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 2. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated an improvement.
Outcome measures
| Measure |
Placebo Ocular Insert + Timolol 0.5% (Period A/B)
n=39 Participants
Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular insert in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued.
|
2.2 mg Bimatoprost Ocular Insert (Period A/B)
n=40 Participants
Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.
|
13 mg Bimatoprost Ocular Insert (Period A/B)
n=40 Participants
Following the washout period, 13 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops to each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 13 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.
|
|---|---|---|---|
|
Change From Baseline in IOP at Week 2
Change from Baseline to Week 2 (T=0 hour)
|
-6.84 mm Hg
Standard Deviation 2.264
|
-4.56 mm Hg
Standard Deviation 3.134
|
-5.95 mm Hg
Standard Deviation 2.367
|
|
Change From Baseline in IOP at Week 2
Change from Baseline to Week 2 (T=2 hour)
|
-5.71 mm Hg
Standard Deviation 2.277
|
-4.14 mm Hg
Standard Deviation 2.637
|
-5.34 mm Hg
Standard Deviation 2.499
|
|
Change From Baseline in IOP at Week 2
Change from Baseline to Week 2 (T=8 hour)
|
-4.81 mm Hg
Standard Deviation 2.612
|
-3.76 mm Hg
Standard Deviation 2.320
|
-4.52 mm Hg
Standard Deviation 2.594
|
SECONDARY outcome
Timeframe: Baseline (Day 0) to Week 6Population: Participants from the FAS, all participants who were randomized, treated and returned for at least one post-treatment visit, with data available at Week 6.
IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 6. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated an improvement.
Outcome measures
| Measure |
Placebo Ocular Insert + Timolol 0.5% (Period A/B)
n=39 Participants
Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular insert in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued.
|
2.2 mg Bimatoprost Ocular Insert (Period A/B)
n=36 Participants
Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.
|
13 mg Bimatoprost Ocular Insert (Period A/B)
n=38 Participants
Following the washout period, 13 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops to each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 13 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.
|
|---|---|---|---|
|
Change From Baseline in IOP at Week 6
Change from Baseline to Week 6 (T=0 hour)
|
-6.42 mm Hg
Standard Deviation 2.770
|
-4.87 mm Hg
Standard Deviation 3.212
|
-5.30 mm Hg
Standard Deviation 2.941
|
|
Change From Baseline in IOP at Week 6
Change from Baseline to Week 6 (T=2 hour)
|
-4.97 mm Hg
Standard Deviation 2.948
|
-4.40 mm Hg
Standard Deviation 3.138
|
-4.42 mm Hg
Standard Deviation 2.830
|
|
Change From Baseline in IOP at Week 6
Change from Baseline to Week 6 (T=8 hour)
|
-4.40 mm Hg
Standard Deviation 2.529
|
-3.73 mm Hg
Standard Deviation 2.393
|
-3.77 mm Hg
Standard Deviation 2.291
|
SECONDARY outcome
Timeframe: Baseline (Day 0) to Weeks 14, 18 and 24Population: Participants from the FAS, all participants who were randomized, treated and returned for at least one post-treatment visit, with data available at the given timepoint.
IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Weeks 14, 18 and 24. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated an improvement.
Outcome measures
| Measure |
Placebo Ocular Insert + Timolol 0.5% (Period A/B)
n=113 Participants
Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular insert in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued.
|
2.2 mg Bimatoprost Ocular Insert (Period A/B)
Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.
|
13 mg Bimatoprost Ocular Insert (Period A/B)
Following the washout period, 13 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops to each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 13 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.
|
|---|---|---|---|
|
Change From Baseline in IOP in Period C
Change from Baseline to Week 14 (T=0 hour)
|
-5.72 mm Hg
Standard Deviation 2.919
|
—
|
—
|
|
Change From Baseline in IOP in Period C
Change from Baseline to Week 14 (T=2 hour)
|
-4.64 mm Hg
Standard Deviation 3.100
|
—
|
—
|
|
Change From Baseline in IOP in Period C
Change from Baseline to Week 14 (T=8 hour)
|
-4.13 mm Hg
Standard Deviation 2.849
|
—
|
—
|
|
Change From Baseline in IOP in Period C
Change from Baseline to Week 18 (T=0 hour)
|
-5.62 mm Hg
Standard Deviation 3.135
|
—
|
—
|
|
Change From Baseline in IOP in Period C
Change from Baseline to Week 18 (T=2 hour)
|
-4.33 mm Hg
Standard Deviation 3.072
|
—
|
—
|
|
Change From Baseline in IOP in Period C
Change from Baseline to Week 18 (T=8 hour)
|
-4.17 mm Hg
Standard Deviation 2.714
|
—
|
—
|
|
Change From Baseline in IOP in Period C
Change from Baseline to Week 24 (T=0 hour)
|
-4.85 mm Hg
Standard Deviation 2.882
|
—
|
—
|
|
Change From Baseline in IOP in Period C
Change from Baseline to Week 24 (T=2 hour)
|
-3.99 mm Hg
Standard Deviation 2.847
|
—
|
—
|
|
Change From Baseline in IOP in Period C
Change from Baseline to Week 24 (T=8 hour)
|
-2.99 mm Hg
Standard Deviation 3.010
|
—
|
—
|
Adverse Events
Washout + Placebo Ocular Insert
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo Ocular Insert + Timolol 0.5%
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
2.2 mg Bimatoprost Ocular Insert
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
13 mg Bimatoprost Ocular Insert
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Washout + Placebo Ocular Insert
n=156 participants at risk
Glaucoma medication washout and placebo ocular insert in each eye for 4 to 6 weeks prior to randomization.
|
Placebo Ocular Insert + Timolol 0.5%
n=40 participants at risk
Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular inserts in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued. In Treatment Period C all participants were fitted with 13 mg Bimatoprost Ocular Inserts for 12 weeks.
|
2.2 mg Bimatoprost Ocular Insert
n=40 participants at risk
Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued. In Treatment Period C all participants were fitted with 13 mg Bimatoprost Ocular Insert in each eye for 12 weeks.
|
13 mg Bimatoprost Ocular Insert
n=41 participants at risk
Following the washout period, 13 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 13 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued. In Treatment Period C all participants were fitted with 13 mg Bimatoprost Ocular Insert in each eye for 12 weeks.
|
|---|---|---|---|---|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/156 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
2.5%
1/40 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
0.00%
0/40 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
0.00%
0/41 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
|
General disorders
Device dislocation
|
0.00%
0/156 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
2.5%
1/40 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
0.00%
0/40 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
0.00%
0/41 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
|
Nervous system disorders
Brain hypoxia
|
0.00%
0/156 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
0.00%
0/40 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
2.5%
1/40 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
0.00%
0/41 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/156 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
0.00%
0/40 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
0.00%
0/40 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
2.4%
1/41 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/156 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
2.5%
1/40 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
0.00%
0/40 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
0.00%
0/41 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/156 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
2.5%
1/40 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
0.00%
0/40 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
0.00%
0/41 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
Other adverse events
| Measure |
Washout + Placebo Ocular Insert
n=156 participants at risk
Glaucoma medication washout and placebo ocular insert in each eye for 4 to 6 weeks prior to randomization.
|
Placebo Ocular Insert + Timolol 0.5%
n=40 participants at risk
Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular inserts in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued. In Treatment Period C all participants were fitted with 13 mg Bimatoprost Ocular Inserts for 12 weeks.
|
2.2 mg Bimatoprost Ocular Insert
n=40 participants at risk
Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued. In Treatment Period C all participants were fitted with 13 mg Bimatoprost Ocular Insert in each eye for 12 weeks.
|
13 mg Bimatoprost Ocular Insert
n=41 participants at risk
Following the washout period, 13 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 13 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued. In Treatment Period C all participants were fitted with 13 mg Bimatoprost Ocular Insert in each eye for 12 weeks.
|
|---|---|---|---|---|
|
Eye disorders
Conjunctival hyperaemia
|
1.9%
3/156 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
5.0%
2/40 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
7.5%
3/40 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
7.3%
3/41 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
|
Eye disorders
Eye discharge
|
3.2%
5/156 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
12.5%
5/40 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
17.5%
7/40 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
17.1%
7/41 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
|
Eye disorders
Eye pruritus
|
0.64%
1/156 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
7.5%
3/40 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
5.0%
2/40 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
2.4%
1/41 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
|
Eye disorders
Punctate keratitis
|
0.00%
0/156 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
7.5%
3/40 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
2.5%
1/40 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
14.6%
6/41 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/156 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
5.0%
2/40 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
5.0%
2/40 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
2.4%
1/41 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
|
Eye disorders
Eye irritation
|
0.00%
0/156 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
5.0%
2/40 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
2.5%
1/40 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
0.00%
0/41 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
|
Eye disorders
Dry eye
|
0.00%
0/156 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
5.0%
2/40 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
0.00%
0/40 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
0.00%
0/41 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.64%
1/156 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
5.0%
2/40 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
2.5%
1/40 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
7.3%
3/41 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/156 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
5.0%
2/40 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
0.00%
0/40 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
2.4%
1/41 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/156 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
2.5%
1/40 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
0.00%
0/40 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
7.3%
3/41 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
|
Vascular disorders
Hypertension
|
0.64%
1/156 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
5.0%
2/40 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
0.00%
0/40 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
7.3%
3/41 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
|
Eye disorders
Vision blurred
|
0.00%
0/156 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
2.5%
1/40 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
2.5%
1/40 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
9.8%
4/41 • Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm. During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee No presentation or publication of Institution's data relating to the Trial may occur until after the Trial has been completed at all sites. If Investigator desires to present or publish, investigator must submit any and all manuscripts, posters, abstracts, or other intended publications (hereinafter collectively referred to as "manuscripts") to Sponsor at least sixty (60) days prior to the actual submission of such manuscript(s) for publication.
- Publication restrictions are in place
Restriction type: OTHER