Trial Outcomes & Findings for ESBA1008 Microvolume Study (NCT NCT01849692)
NCT ID: NCT01849692
Last Updated: 2016-03-24
Results Overview
A subject was considered a responder if at least 3 out of the following 4 criteria were fulfilled in comparison to baseline: * Greater than or equal to 4 letter gain in BCVA at Day 14 * Greater than or equal to 4 letter gain in BCVA at Day 28 * Greater than or equal to 80 micron decrease in CSFT at Day 14 * Greater than or equal to 80 micron decrease in CSFT at Day 28. BCVA was measured by the number of letters read out of a possible 70 letters on the ETDRS chart. One eye (study eye) contributed to the analysis.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
107 participants
Primary outcome timeframe
Baseline, Day 14, Day 28
Results posted on
2016-03-24
Participant Flow
Subjects were recruited from 12 investigational centers located in the US, Australia, and the Dominican Republic.
Of the 107 enrolled, 55 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized participants (52).
Participant milestones
| Measure |
Cohort 1 - ESBA
ESBA1008 solution Day 0 (1.2 mg) and Day 28 (6 mg)
|
Cohort 1 - Ranibizumab
Ranibizumab 0.5 mg injection, Day 0 and Day 28
|
Cohort 2 - ESBA
ESBA1008 solution Day 0 (1 mg) and Day 28 (6 mg)
|
Cohort 2 - Ranibizumab
Ranibizumab 0.5 mg injection, Day 0 and Day 28
|
Cohort 3 - ESBA
ESBA1008 solution Day 0 (0.6 mg) and Day 28 (6 mg)
|
Cohort 3 - Ranibizumab
Ranibizumab 0.5 mg injection, Day 0 and Day 28
|
Cohort 4 - ESBA
ESBA1008 solution Day 0 (0.5 mg) and Day 28 (6 mg)
|
Cohort 4 - Ranibizumab
Ranibizumab 0.5 mg injection, Day 0 and Day 28
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
3
|
10
|
3
|
10
|
3
|
10
|
3
|
|
Overall Study
COMPLETED
|
10
|
3
|
10
|
3
|
10
|
3
|
10
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ESBA1008 Microvolume Study
Baseline characteristics by cohort
| Measure |
ESBA
n=40 Participants
All subjects who were treated with ESBA1008.
|
LUCENTIS
n=12 Participants
All subjects who were treated with LUCENTIS.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Cohort 1, n=10, 3
|
77.5 years
STANDARD_DEVIATION 3.6 • n=5 Participants
|
78.3 years
STANDARD_DEVIATION 7.2 • n=7 Participants
|
77.7 years
STANDARD_DEVIATION 4.3 • n=5 Participants
|
|
Age, Continuous
Cohort 2, n=10, 3
|
73.6 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
82.0 years
STANDARD_DEVIATION 3.6 • n=7 Participants
|
75.5 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Age, Continuous
Cohort 3, n=10, 3
|
76.5 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
81.7 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
77.7 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Age, Continuous
Cohort 4, n=10, 3
|
81.6 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
76.7 years
STANDARD_DEVIATION 3.8 • n=7 Participants
|
80.5 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
|
Sex/Gender, Customized
Cohort 1, Female
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Sex/Gender, Customized
Cohort 1, Male
|
7 participants
n=5 Participants
|
2 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Sex/Gender, Customized
Cohort 2, Female
|
6 participants
n=5 Participants
|
2 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Sex/Gender, Customized
Cohort 2, Male
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Sex/Gender, Customized
Cohort 3, Female
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Sex/Gender, Customized
Cohort 3, Male
|
5 participants
n=5 Participants
|
1 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Sex/Gender, Customized
Cohort 4, Female
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Sex/Gender, Customized
Cohort 4, Male
|
6 participants
n=5 Participants
|
2 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Best corrected visual acuity (BCVA)
Cohort 1, n=10, 3
|
63.4 letters
STANDARD_DEVIATION 6.8 • n=5 Participants
|
55.0 letters
STANDARD_DEVIATION 8.7 • n=7 Participants
|
61.5 letters
STANDARD_DEVIATION 7.8 • n=5 Participants
|
|
Best corrected visual acuity (BCVA)
Cohort 2, n=10, 3
|
61.0 letters
STANDARD_DEVIATION 11.8 • n=5 Participants
|
64.3 letters
STANDARD_DEVIATION 6.8 • n=7 Participants
|
61.8 letters
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Best corrected visual acuity (BCVA)
Cohort 3, n=10, 3
|
60.2 letters
STANDARD_DEVIATION 14.7 • n=5 Participants
|
59.3 letters
STANDARD_DEVIATION 5.1 • n=7 Participants
|
60.0 letters
STANDARD_DEVIATION 12.9 • n=5 Participants
|
|
Best corrected visual acuity (BCVA)
Cohort 4, n=10, 3
|
54.8 letters
STANDARD_DEVIATION 14.2 • n=5 Participants
|
48.7 letters
STANDARD_DEVIATION 16.9 • n=7 Participants
|
53.4 letters
STANDARD_DEVIATION 14.4 • n=5 Participants
|
|
Central subfield thickness (CSFT)
Cohort 1, n=10, 3
|
535.1 microns
STANDARD_DEVIATION 194.7 • n=5 Participants
|
482.3 microns
STANDARD_DEVIATION 104.3 • n=7 Participants
|
522.9 microns
STANDARD_DEVIATION 175.5 • n=5 Participants
|
|
Central subfield thickness (CSFT)
Cohort 2, n=10, 3
|
423.0 microns
STANDARD_DEVIATION 95.5 • n=5 Participants
|
405.7 microns
STANDARD_DEVIATION 19.9 • n=7 Participants
|
419.0 microns
STANDARD_DEVIATION 83.5 • n=5 Participants
|
|
Central subfield thickness (CSFT)
Cohort 3, n=10, 3
|
479.1 microns
STANDARD_DEVIATION 93.7 • n=5 Participants
|
403.3 microns
STANDARD_DEVIATION 67.7 • n=7 Participants
|
461.6 microns
STANDARD_DEVIATION 91.9 • n=5 Participants
|
|
Central subfield thickness (CSFT)
Cohort 4, n=10, 3
|
534.8 microns
STANDARD_DEVIATION 123.4 • n=5 Participants
|
573.3 microns
STANDARD_DEVIATION 160.6 • n=7 Participants
|
543.7 microns
STANDARD_DEVIATION 126.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 14, Day 28Population: This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables (BCVA and/or CSFT). Here, "n" is the number of subjects in each arm group.
A subject was considered a responder if at least 3 out of the following 4 criteria were fulfilled in comparison to baseline: * Greater than or equal to 4 letter gain in BCVA at Day 14 * Greater than or equal to 4 letter gain in BCVA at Day 28 * Greater than or equal to 80 micron decrease in CSFT at Day 14 * Greater than or equal to 80 micron decrease in CSFT at Day 28. BCVA was measured by the number of letters read out of a possible 70 letters on the ETDRS chart. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Cohort 1
n=13 Participants
ESBA1008 solution Day 0 (1.2 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
|
Cohort 2
n=13 Participants
ESBA1008 solution Day 0 (1 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
|
Cohort 3
n=13 Participants
ESBA1008 solution Day 0 (0.6 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
|
Cohort 4
n=13 Participants
ESBA1008 solution Day 0 (0.5 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
|
|---|---|---|---|---|
|
Percentage of Responders Based on CSFT and BCVA Outcomes at Day 14 and Day 28
LUCENTIS, n=3
|
100 percentage of responders
Interval 36.8 to 100.0
|
100 percentage of responders
Interval 36.8 to 100.0
|
33.3 percentage of responders
Interval 1.7 to 86.5
|
66.7 percentage of responders
Interval 13.5 to 98.3
|
|
Percentage of Responders Based on CSFT and BCVA Outcomes at Day 14 and Day 28
ESBA, n=10
|
70 percentage of responders
Interval 39.3 to 91.3
|
60 percentage of responders
Interval 30.4 to 85.0
|
80 percentage of responders
Interval 49.3 to 96.3
|
60 percentage of responders
Interval 30.4 to 85.0
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Day 14, Day 28, Day 42, Day 56Population: This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with last observation carried forward (LOCF) imputation for missing values.
BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly out of 70 letters on the chart. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Cohort 1
n=10 Participants
ESBA1008 solution Day 0 (1.2 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
|
Cohort 2
n=3 Participants
ESBA1008 solution Day 0 (1 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
|
Cohort 3
ESBA1008 solution Day 0 (0.6 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
|
Cohort 4
ESBA1008 solution Day 0 (0.5 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
|
|---|---|---|---|---|
|
Change From Baseline in BCVA, Cohort 1
Day 7
|
4.5 letters
Standard Deviation 6.5
|
4.7 letters
Standard Deviation 7.4
|
—
|
—
|
|
Change From Baseline in BCVA, Cohort 1
Day 14
|
5.9 letters
Standard Deviation 6.1
|
6.3 letters
Standard Deviation 7.6
|
—
|
—
|
|
Change From Baseline in BCVA, Cohort 1
Day 28
|
7.7 letters
Standard Deviation 5.2
|
10.3 letters
Standard Deviation 6.1
|
—
|
—
|
|
Change From Baseline in BCVA, Cohort 1
Day 42
|
10.3 letters
Standard Deviation 4.9
|
8.3 letters
Standard Deviation 5.9
|
—
|
—
|
|
Change From Baseline in BCVA, Cohort 1
Day 56
|
11.1 letters
Standard Deviation 8.0
|
11.7 letters
Standard Deviation 5.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Day 14, Day 28, Day 42, Day 56Population: This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with LOCF imputation for missing values.
BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly out of 70 letters on the chart. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Cohort 1
n=10 Participants
ESBA1008 solution Day 0 (1.2 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
|
Cohort 2
n=3 Participants
ESBA1008 solution Day 0 (1 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
|
Cohort 3
ESBA1008 solution Day 0 (0.6 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
|
Cohort 4
ESBA1008 solution Day 0 (0.5 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
|
|---|---|---|---|---|
|
Change From Baseline in BCVA, Cohort 2
Day 28
|
5.5 letters
Standard Deviation 6.0
|
10.3 letters
Standard Deviation 11.2
|
—
|
—
|
|
Change From Baseline in BCVA, Cohort 2
Day 42
|
8.1 letters
Standard Deviation 9.6
|
10.3 letters
Standard Deviation 11.0
|
—
|
—
|
|
Change From Baseline in BCVA, Cohort 2
Day 7
|
2.4 letters
Standard Deviation 6.2
|
7.0 letters
Standard Deviation 13.0
|
—
|
—
|
|
Change From Baseline in BCVA, Cohort 2
Day 14
|
4.8 letters
Standard Deviation 4.0
|
7.3 letters
Standard Deviation 10.4
|
—
|
—
|
|
Change From Baseline in BCVA, Cohort 2
Day 56
|
8.0 letters
Standard Deviation 7.3
|
10.7 letters
Standard Deviation 10.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Day 14, Day 28, Day 42, Day 56Population: This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with LOCF imputation for missing values.
BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly out of 70 letters on the chart. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Cohort 1
n=10 Participants
ESBA1008 solution Day 0 (1.2 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
|
Cohort 2
n=3 Participants
ESBA1008 solution Day 0 (1 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
|
Cohort 3
ESBA1008 solution Day 0 (0.6 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
|
Cohort 4
ESBA1008 solution Day 0 (0.5 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
|
|---|---|---|---|---|
|
Change From Baseline in BCVA, Cohort 3
Day 7
|
10.3 letters
Standard Deviation 9.0
|
5.0 letters
Standard Deviation 4.6
|
—
|
—
|
|
Change From Baseline in BCVA, Cohort 3
Day 14
|
9.8 letters
Standard Deviation 12.0
|
7.3 letters
Standard Deviation 7.8
|
—
|
—
|
|
Change From Baseline in BCVA, Cohort 3
Day 28
|
13.5 letters
Standard Deviation 10.4
|
5.0 letters
Standard Deviation 6.9
|
—
|
—
|
|
Change From Baseline in BCVA, Cohort 3
Day 42
|
15.0 letters
Standard Deviation 10.1
|
6.0 letters
Standard Deviation 6.2
|
—
|
—
|
|
Change From Baseline in BCVA, Cohort 3
Day 56
|
13.7 letters
Standard Deviation 9.9
|
9.3 letters
Standard Deviation 1.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Day 14, Day 28, Day 42, Day 56Population: This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with LOCF imputation for missing values.
BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly out of 70 letters on the chart. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Cohort 1
n=10 Participants
ESBA1008 solution Day 0 (1.2 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
|
Cohort 2
n=3 Participants
ESBA1008 solution Day 0 (1 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
|
Cohort 3
ESBA1008 solution Day 0 (0.6 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
|
Cohort 4
ESBA1008 solution Day 0 (0.5 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
|
|---|---|---|---|---|
|
Change From Baseline in BCVA, Cohort 4
Day 7
|
3.2 letters
Standard Deviation 6.0
|
9.3 letters
Standard Deviation 14.5
|
—
|
—
|
|
Change From Baseline in BCVA, Cohort 4
Day 14
|
7.1 letters
Standard Deviation 7.6
|
12.3 letters
Standard Deviation 11.8
|
—
|
—
|
|
Change From Baseline in BCVA, Cohort 4
Day 28
|
4.7 letters
Standard Deviation 3.8
|
11.7 letters
Standard Deviation 15.1
|
—
|
—
|
|
Change From Baseline in BCVA, Cohort 4
Day 42
|
6.6 letters
Standard Deviation 5.3
|
17.3 letters
Standard Deviation 17.9
|
—
|
—
|
|
Change From Baseline in BCVA, Cohort 4
Day 56
|
7.6 letters
Standard Deviation 7.1
|
18.7 letters
Standard Deviation 14.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Day 14, Day 28, Day 42, Day 56Population: This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with LOCF imputation for missing values.
CSFT was assessed by Spectral-Domain Optical Coherence Tomography (SD-OCT) and measured in microns. A decrease in CSFT indicates improvement. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Cohort 1
n=10 Participants
ESBA1008 solution Day 0 (1.2 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
|
Cohort 2
n=3 Participants
ESBA1008 solution Day 0 (1 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
|
Cohort 3
ESBA1008 solution Day 0 (0.6 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
|
Cohort 4
ESBA1008 solution Day 0 (0.5 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
|
|---|---|---|---|---|
|
Change From Baseline in CSFT, Cohort 1
Day 7
|
-114.0 microns
Standard Deviation 167.1
|
-99.7 microns
Standard Deviation 16.3
|
—
|
—
|
|
Change From Baseline in CSFT, Cohort 1
Day 14
|
-188.2 microns
Standard Deviation 122.0
|
-130.3 microns
Standard Deviation 39.7
|
—
|
—
|
|
Change From Baseline in CSFT, Cohort 1
Day 28
|
-182.0 microns
Standard Deviation 106.7
|
-175.3 microns
Standard Deviation 71.8
|
—
|
—
|
|
Change From Baseline in CSFT, Cohort 1
Day 42
|
-221.0 microns
Standard Deviation 156.3
|
-183.7 microns
Standard Deviation 74.3
|
—
|
—
|
|
Change From Baseline in CSFT, Cohort 1
Day 56
|
-226.3 microns
Standard Deviation 145.7
|
-162.7 microns
Standard Deviation 68.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Day 14, Day 28, Day 42, Day 56Population: This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with LOCF imputation for missing values.
CSFT was assessed by SD-OCT and measured in microns. A decrease in CSFT indicates improvement. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Cohort 1
n=10 Participants
ESBA1008 solution Day 0 (1.2 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
|
Cohort 2
n=3 Participants
ESBA1008 solution Day 0 (1 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
|
Cohort 3
ESBA1008 solution Day 0 (0.6 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
|
Cohort 4
ESBA1008 solution Day 0 (0.5 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
|
|---|---|---|---|---|
|
Change From Baseline in CSFT, Cohort 2
Day 7
|
-57.9 microns
Standard Deviation 38.1
|
-87.7 microns
Standard Deviation 32.7
|
—
|
—
|
|
Change From Baseline in CSFT, Cohort 2
Day 14
|
-96.5 microns
Standard Deviation 45.3
|
-116.0 microns
Standard Deviation 19.7
|
—
|
—
|
|
Change From Baseline in CSFT, Cohort 2
Day 28
|
-104.9 microns
Standard Deviation 44.2
|
-142.3 microns
Standard Deviation 18.1
|
—
|
—
|
|
Change From Baseline in CSFT, Cohort 2
Day 42
|
-133.1 microns
Standard Deviation 83.3
|
-148.3 microns
Standard Deviation 26.0
|
—
|
—
|
|
Change From Baseline in CSFT, Cohort 2
Day 56
|
-137.9 microns
Standard Deviation 73.9
|
-155.0 microns
Standard Deviation 26.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Day 14, Day 28, Day 42, Day 56Population: This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with LOCF imputation for missing values.
CSFT was assessed by SD-OCT and measured in microns. A decrease in CSFT indicates improvement. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Cohort 1
n=10 Participants
ESBA1008 solution Day 0 (1.2 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
|
Cohort 2
n=3 Participants
ESBA1008 solution Day 0 (1 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
|
Cohort 3
ESBA1008 solution Day 0 (0.6 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
|
Cohort 4
ESBA1008 solution Day 0 (0.5 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
|
|---|---|---|---|---|
|
Change From Baseline in CSFT, Cohort 3
Day 7
|
-93.4 microns
Standard Deviation 50.1
|
-54.0 microns
Standard Deviation 59.6
|
—
|
—
|
|
Change From Baseline in CSFT, Cohort 3
Day 14
|
-126.8 microns
Standard Deviation 61.0
|
-85.7 microns
Standard Deviation 87.4
|
—
|
—
|
|
Change From Baseline in CSFT, Cohort 3
Day 28
|
-163.1 microns
Standard Deviation 74.4
|
-104.0 microns
Standard Deviation 73.5
|
—
|
—
|
|
Change From Baseline in CSFT, Cohort 3
Day 42
|
-194.4 microns
Standard Deviation 66.9
|
-128.3 microns
Standard Deviation 73.8
|
—
|
—
|
|
Change From Baseline in CSFT, Cohort 3
Day 56
|
-205.4 microns
Standard Deviation 78.6
|
-108.7 microns
Standard Deviation 88.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Day 14, Day 28, Day 42, Day 56Population: This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with LOCF imputation for missing values.
CSFT was assessed by SD-OCT and measured in microns. A decrease in CSFT indicates improvement. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Cohort 1
n=10 Participants
ESBA1008 solution Day 0 (1.2 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
|
Cohort 2
n=3 Participants
ESBA1008 solution Day 0 (1 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
|
Cohort 3
ESBA1008 solution Day 0 (0.6 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
|
Cohort 4
ESBA1008 solution Day 0 (0.5 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
|
|---|---|---|---|---|
|
Change From Baseline in CSFT, Cohort 4
Day 7
|
-102.8 microns
Standard Deviation 111.1
|
-105.3 microns
Standard Deviation 72.2
|
—
|
—
|
|
Change From Baseline in CSFT, Cohort 4
Day 14
|
-119.9 microns
Standard Deviation 129.3
|
-194.3 microns
Standard Deviation 148.9
|
—
|
—
|
|
Change From Baseline in CSFT, Cohort 4
Day 28
|
-125.1 microns
Standard Deviation 143.6
|
-187.3 microns
Standard Deviation 195.7
|
—
|
—
|
|
Change From Baseline in CSFT, Cohort 4
Day 42
|
-184.2 microns
Standard Deviation 110.2
|
-253.0 microns
Standard Deviation 181.2
|
—
|
—
|
|
Change From Baseline in CSFT, Cohort 4
Day 56
|
-203.5 microns
Standard Deviation 105.8
|
-213.7 microns
Standard Deviation 228.2
|
—
|
—
|
Adverse Events
Stage 1 ESBA 1.2 mg INJ
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Stage 1 ESBA 1 mg INF
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Stage 1 LUCENTIS 0.5 mg INJ
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Stage 2 ESBA 0.6 mg INJ
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Stage 2 ESBA 0.5 mg INF
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Stage 2 LUCENTIS 0.5 mg INJ
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Pretreatment
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stage 1 ESBA 1.2 mg INJ
n=10 participants at risk
All subjects treated with ESBA1008 1.2 mg via injection
|
Stage 1 ESBA 1 mg INF
n=10 participants at risk
All subjects treated with ESBA1008 1 mg via infusion
|
Stage 1 LUCENTIS 0.5 mg INJ
n=6 participants at risk
All subjects treated with LUCENTIS via injection in Stage 1
|
Stage 2 ESBA 0.6 mg INJ
n=10 participants at risk
All subjects treated with ESBA1008 0.6 mg via injection
|
Stage 2 ESBA 0.5 mg INF
n=10 participants at risk
All subjects treated with ESBA1008 0.5 mg via infusion
|
Stage 2 LUCENTIS 0.5 mg INJ
n=6 participants at risk
All subjects treated with LUCENTIS via injection in Stage 2
|
Pretreatment
n=107 participants at risk
All subjects who consented to participate in the study prior to the initiation of study treatment
|
|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
10.0%
1/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
10.0%
1/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.93%
1/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
Other adverse events
| Measure |
Stage 1 ESBA 1.2 mg INJ
n=10 participants at risk
All subjects treated with ESBA1008 1.2 mg via injection
|
Stage 1 ESBA 1 mg INF
n=10 participants at risk
All subjects treated with ESBA1008 1 mg via infusion
|
Stage 1 LUCENTIS 0.5 mg INJ
n=6 participants at risk
All subjects treated with LUCENTIS via injection in Stage 1
|
Stage 2 ESBA 0.6 mg INJ
n=10 participants at risk
All subjects treated with ESBA1008 0.6 mg via injection
|
Stage 2 ESBA 0.5 mg INF
n=10 participants at risk
All subjects treated with ESBA1008 0.5 mg via infusion
|
Stage 2 LUCENTIS 0.5 mg INJ
n=6 participants at risk
All subjects treated with LUCENTIS via injection in Stage 2
|
Pretreatment
n=107 participants at risk
All subjects who consented to participate in the study prior to the initiation of study treatment
|
|---|---|---|---|---|---|---|---|
|
Endocrine disorders
Androgen deficiency
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Eye disorders
Abnormal sensation in eye
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
10.0%
1/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Eye disorders
Blepharitis
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Eye disorders
Chalazion
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Eye disorders
Choroidal neovascularisation
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
10.0%
1/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Eye disorders
Conjunctival haemorrhage
|
10.0%
1/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
20.0%
2/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
10.0%
1/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
10.0%
1/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Eye disorders
Conjunctival oedema
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
10.0%
1/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Eye disorders
Corneal epithelium defect
|
10.0%
1/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Eye disorders
Eye irritation
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
10.0%
1/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
10.0%
1/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Eye disorders
Eye pain
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
10.0%
1/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
10.0%
1/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
20.0%
2/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Eye disorders
Eyelid pain
|
10.0%
1/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Eye disorders
Eyelids pruritus
|
10.0%
1/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Eye disorders
Foreign body sensation in eyes
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Eye disorders
Metamorphopsia
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
10.0%
1/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Eye disorders
Ocular discomfort
|
10.0%
1/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
10.0%
1/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Eye disorders
Retinal pigment epitheliopathy
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Eye disorders
Vision blurred
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Eye disorders
Visual impairment
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
10.0%
1/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Eye disorders
Vitreous floaters
|
10.0%
1/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
10.0%
1/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Eye disorders
Xanthopsia
|
10.0%
1/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Gastrointestinal disorders
Dental caries
|
10.0%
1/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
1/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
10.0%
1/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
10.0%
1/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
10.0%
1/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
10.0%
1/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Infections and infestations
Bronchitis
|
20.0%
2/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Infections and infestations
Keratitis bacterial
|
10.0%
1/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
10.0%
1/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
10.0%
1/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
10.0%
1/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Injury, poisoning and procedural complications
Traumatic haemorrhage
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
10.0%
1/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Investigations
Biopsy ear
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Investigations
Blood pressure increased
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
10.0%
1/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
10.0%
1/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.93%
1/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
10.0%
1/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.93%
1/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
10.0%
1/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.93%
1/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
10.0%
1/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
33.3%
2/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
10.0%
1/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
10.0%
1/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
|
Vascular disorders
Hypertension
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
10.0%
1/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
0.93%
1/107 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to visit Day 56). Ocular adverse events are presented for both study eye and non-study eye. AEs were reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject administered study drug. AEs were obtained as solicited comments from subjects and as observations by the Investigator as outlined in the protocol.
|
Additional Information
Clinical Project Group Leader, GCRA, Pharma
Alcon Research, Ltd.
Phone: 1-888-451-3937
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER