Trial Outcomes & Findings for Pharmacokinetics of CLG561 in Patients With Advanced Age-Related Macular Degeneration (NCT NCT01835015)
NCT ID: NCT01835015
Last Updated: 2016-03-25
Results Overview
BCVA (with spectacles or other visual corrective devices) using Early Treatment Diabetic Retinopathy Study (ETDRS) testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
50 participants
Primary outcome timeframe
Baseline, Day 2, Day 4, Day 15, Day 29, Day 57, Day 85
Results posted on
2016-03-25
Participant Flow
Subjects were recruited from 4 investigational centers located in the US.
Of the 50 enrolled,19 subjects were exited as screen failures prior to randomization. This reporting group includes all assigned subjects (31).
Participant milestones
| Measure |
CLG561, Level A
Single 50 μL intravitreal injection of CLG561, Dose Level A
|
CLG561, Level B
Single 50 μL intravitreal injection of CLG561, Dose Level B
|
CLG561, Level C
Single 50 μL intravitreal injection of CLG561, Dose Level C
|
CLG561, Level D
Single 50 μL intravitreal injection of CLG561, Dose Level D
|
CLG561, Level E
Single 100 μL intravitreal injection of CLG561, Dose Level E
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
7
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
CLG561, Level A
Single 50 μL intravitreal injection of CLG561, Dose Level A
|
CLG561, Level B
Single 50 μL intravitreal injection of CLG561, Dose Level B
|
CLG561, Level C
Single 50 μL intravitreal injection of CLG561, Dose Level C
|
CLG561, Level D
Single 50 μL intravitreal injection of CLG561, Dose Level D
|
CLG561, Level E
Single 100 μL intravitreal injection of CLG561, Dose Level E
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Pharmacokinetics of CLG561 in Patients With Advanced Age-Related Macular Degeneration
Baseline characteristics by cohort
| Measure |
CLG561, Level A
n=6 Participants
Single 50 μL intravitreal injection of CLG561, Dose Level A
|
CLG561, Level B
n=6 Participants
Single 50 μL intravitreal injection of CLG561, Dose Level B
|
CLG561, Level C
n=7 Participants
Single 50 μL intravitreal injection of CLG561, Dose Level C
|
CLG561, Level D
n=6 Participants
Single 50 μL intravitreal injection of CLG561, Dose Level D
|
CLG561, Level E
n=6 Participants
Single 100 μL intravitreal injection of CLG561, Dose Level E
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
74.2 years
STANDARD_DEVIATION 6.82 • n=93 Participants
|
76.2 years
STANDARD_DEVIATION 8.80 • n=4 Participants
|
76.1 years
STANDARD_DEVIATION 6.69 • n=27 Participants
|
73.3 years
STANDARD_DEVIATION 9.52 • n=483 Participants
|
76.5 years
STANDARD_DEVIATION 10.86 • n=36 Participants
|
75.3 years
STANDARD_DEVIATION 8.12 • n=10 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
19 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
12 Participants
n=10 Participants
|
|
Primary Diagnosis
Geographic atrophy
|
0 participants
n=93 Participants
|
2 participants
n=4 Participants
|
2 participants
n=27 Participants
|
1 participants
n=483 Participants
|
2 participants
n=36 Participants
|
7 participants
n=10 Participants
|
|
Primary Diagnosis
Exudative macular degeneration
|
6 participants
n=93 Participants
|
4 participants
n=4 Participants
|
5 participants
n=27 Participants
|
5 participants
n=483 Participants
|
4 participants
n=36 Participants
|
24 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 2, Day 4, Day 15, Day 29, Day 57, Day 85Population: This analysis population includes all enrolled subjects who received investigational product. Here, "n" is the number of subjects with non-missing values at the specific time point for each arm group, respectively.
BCVA (with spectacles or other visual corrective devices) using Early Treatment Diabetic Retinopathy Study (ETDRS) testing was reported in letters read correctly. 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 |
CLG561, Level A
n=6 Participants
Single 50 μL intravitreal injection of CLG561, Dose Level A
|
CLG561, Level B
n=6 Participants
Single 50 μL intravitreal injection of CLG561, Dose Level B
|
CLG561, Level C
n=7 Participants
Single 50 μL intravitreal injection of CLG561, Dose Level C
|
CLG561, Level D
n=6 Participants
Single 50 μL intravitreal injection of CLG561, Dose Level D
|
CLG561, Level E
n=6 Participants
Single 100 μL intravitreal injection of CLG561, Dose Level E
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) by Visit - Study Eye
Change from Baseline, Day 29, n=6,5,6,6,6
|
2.2 letters
Standard Deviation 5.85
|
4.8 letters
Standard Deviation 5.02
|
1.3 letters
Standard Deviation 5.28
|
2.0 letters
Standard Deviation 6.84
|
1.5 letters
Standard Deviation 4.51
|
|
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) by Visit - Study Eye
Change from Baseline, Day 57, n=6,5,6,6,6
|
4.7 letters
Standard Deviation 11.09
|
2.0 letters
Standard Deviation 3.24
|
2.5 letters
Standard Deviation 5.75
|
4.2 letters
Standard Deviation 11.09
|
2.3 letters
Standard Deviation 2.94
|
|
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) by Visit - Study Eye
Change from Baseline, Day 85, n=6,6,6,6,6
|
3.8 letters
Standard Deviation 9.43
|
3.0 letters
Standard Deviation 4.86
|
2.2 letters
Standard Deviation 5.12
|
2.2 letters
Standard Deviation 5.12
|
3.2 letters
Standard Deviation 5.12
|
|
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) by Visit - Study Eye
Baseline, n=6,6,7,6,6
|
23.7 letters
Standard Deviation 16.55
|
25.7 letters
Standard Deviation 15.20
|
27.6 letters
Standard Deviation 17.67
|
41.5 letters
Standard Deviation 20.42
|
38.0 letters
Standard Deviation 11.75
|
|
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) by Visit - Study Eye
Change from Baseline, Day 2, n=6,6,7,6,6
|
0.7 letters
Standard Deviation 8.24
|
2.5 letters
Standard Deviation 5.24
|
1.1 letters
Standard Deviation 3.02
|
0.0 letters
Standard Deviation 5.73
|
-1.0 letters
Standard Deviation 10.02
|
|
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) by Visit - Study Eye
Change from Baseline, Day 4, n=6,6,7,6,6
|
3.5 letters
Standard Deviation 8.53
|
4.8 letters
Standard Deviation 4.67
|
1.7 letters
Standard Deviation 3.04
|
1.8 letters
Standard Deviation 5.19
|
3.3 letters
Standard Deviation 7.87
|
|
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) by Visit - Study Eye
Change from Baseline, Day 15, n=6,6,6,6,6
|
2.7 letters
Standard Deviation 7.99
|
3.7 letters
Standard Deviation 4.50
|
2.0 letters
Standard Deviation 4.73
|
3.5 letters
Standard Deviation 8.26
|
5.2 letters
Standard Deviation 8.06
|
PRIMARY outcome
Timeframe: Baseline, Day 1, Day 2, Day 4, Day 15, Day 29, Day 57, Day 85Population: This analysis population includes all enrolled subjects who received investigational product. Here, "n" is the number of subjects with non-missing values at the specific time point for each arm group, respectively.
IOP was measured by Goldmann applanation tonometry or tonopen, at the discretion of the Investigator, and reported in mmHg (millimeters of mercury). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
CLG561, Level A
n=6 Participants
Single 50 μL intravitreal injection of CLG561, Dose Level A
|
CLG561, Level B
n=6 Participants
Single 50 μL intravitreal injection of CLG561, Dose Level B
|
CLG561, Level C
n=7 Participants
Single 50 μL intravitreal injection of CLG561, Dose Level C
|
CLG561, Level D
n=6 Participants
Single 50 μL intravitreal injection of CLG561, Dose Level D
|
CLG561, Level E
n=6 Participants
Single 100 μL intravitreal injection of CLG561, Dose Level E
|
|---|---|---|---|---|---|
|
Mean Intra-Ocular Pressure (IOP) by Visit - Study Eye
Baseline, n=6,6,7,6,6
|
14.7 mmHg
Standard Deviation 2.16
|
14.3 mmHg
Standard Deviation 2.42
|
15.7 mmHg
Standard Deviation 3.86
|
15.2 mmHg
Standard Deviation 3.06
|
16.5 mmHg
Standard Deviation 3.67
|
|
Mean Intra-Ocular Pressure (IOP) by Visit - Study Eye
Day 1, n=6,6,7,6,6
|
16.3 mmHg
Standard Deviation 3.72
|
20.2 mmHg
Standard Deviation 8.01
|
16.6 mmHg
Standard Deviation 6.24
|
22.3 mmHg
Standard Deviation 3.50
|
20.2 mmHg
Standard Deviation 3.97
|
|
Mean Intra-Ocular Pressure (IOP) by Visit - Study Eye
Day 2, n=6,6,7,6,6
|
16.0 mmHg
Standard Deviation 1.79
|
14.5 mmHg
Standard Deviation 1.05
|
14.3 mmHg
Standard Deviation 3.15
|
14.0 mmHg
Standard Deviation 4.00
|
15.0 mmHg
Standard Deviation 3.10
|
|
Mean Intra-Ocular Pressure (IOP) by Visit - Study Eye
Day 4, n=6,6,7,6,6
|
16.2 mmHg
Standard Deviation 2.32
|
14.5 mmHg
Standard Deviation 3.99
|
15.1 mmHg
Standard Deviation 4.74
|
14.7 mmHg
Standard Deviation 4.23
|
15.3 mmHg
Standard Deviation 3.93
|
|
Mean Intra-Ocular Pressure (IOP) by Visit - Study Eye
Day 15, n=6,6,6,6,6
|
14.0 mmHg
Standard Deviation 1.67
|
15.5 mmHg
Standard Deviation 2.81
|
16.2 mmHg
Standard Deviation 6.21
|
16.2 mmHg
Standard Deviation 3.76
|
16.5 mmHg
Standard Deviation 4.09
|
|
Mean Intra-Ocular Pressure (IOP) by Visit - Study Eye
Day 29, n=6,5,6,6,6
|
16.8 mmHg
Standard Deviation 3.19
|
16.8 mmHg
Standard Deviation 4.60
|
16.0 mmHg
Standard Deviation 4.94
|
16.8 mmHg
Standard Deviation 4.26
|
16.2 mmHg
Standard Deviation 4.67
|
|
Mean Intra-Ocular Pressure (IOP) by Visit - Study Eye
Day 57, n=6,5,6,6,6
|
17.7 mmHg
Standard Deviation 2.94
|
15.6 mmHg
Standard Deviation 5.32
|
16.3 mmHg
Standard Deviation 3.27
|
16.3 mmHg
Standard Deviation 2.25
|
15.8 mmHg
Standard Deviation 3.13
|
|
Mean Intra-Ocular Pressure (IOP) by Visit - Study Eye
Day 85, n=6,6,6,6,6
|
16.5 mmHg
Standard Deviation 2.07
|
15.5 mmHg
Standard Deviation 5.24
|
16.7 mmHg
Standard Deviation 4.27
|
16.2 mmHg
Standard Deviation 4.07
|
16.2 mmHg
Standard Deviation 4.26
|
PRIMARY outcome
Timeframe: Baseline, Day 2, Day 4, Day 8, Day 15, Day 29, Day 57, Day 85Population: This analysis population includes all enrolled subjects who received investigational product.
A dilated fundus examination was performed to evaluate the health of the retina, macula, choroid, and optic nerve. Subjects having a normal baseline evaluation were examined at subsequent visits, and any change from normal to abnormal was recorded. Criteria for reclassifying from normal to abnormal were left to the opinion of the investigators. One eye (study eye) contributed to the analysis. None of the abnormalities were deemed related to the study medication.
Outcome measures
| Measure |
CLG561, Level A
n=6 Participants
Single 50 μL intravitreal injection of CLG561, Dose Level A
|
CLG561, Level B
n=6 Participants
Single 50 μL intravitreal injection of CLG561, Dose Level B
|
CLG561, Level C
n=7 Participants
Single 50 μL intravitreal injection of CLG561, Dose Level C
|
CLG561, Level D
n=6 Participants
Single 50 μL intravitreal injection of CLG561, Dose Level D
|
CLG561, Level E
n=6 Participants
Single 100 μL intravitreal injection of CLG561, Dose Level E
|
|---|---|---|---|---|---|
|
Number of Subjects With Change From Normal to Abnormal in Fundus Examination at Any Post-Therapy Visit as Compared to Baseline Assessment
Retina: Baseline Normal
|
5 participants
|
4 participants
|
4 participants
|
6 participants
|
5 participants
|
|
Number of Subjects With Change From Normal to Abnormal in Fundus Examination at Any Post-Therapy Visit as Compared to Baseline Assessment
Retina: Change from Normal to Abnormal
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Subjects With Change From Normal to Abnormal in Fundus Examination at Any Post-Therapy Visit as Compared to Baseline Assessment
Macula: Baseline Normal
|
6 participants
|
6 participants
|
6 participants
|
6 participants
|
6 participants
|
|
Number of Subjects With Change From Normal to Abnormal in Fundus Examination at Any Post-Therapy Visit as Compared to Baseline Assessment
Macula: Change from Normal to Abnormal
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Subjects With Change From Normal to Abnormal in Fundus Examination at Any Post-Therapy Visit as Compared to Baseline Assessment
Choroid: Baseline Normal
|
6 participants
|
6 participants
|
6 participants
|
6 participants
|
6 participants
|
|
Number of Subjects With Change From Normal to Abnormal in Fundus Examination at Any Post-Therapy Visit as Compared to Baseline Assessment
Choroid: Change from Normal to Abnormal
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects With Change From Normal to Abnormal in Fundus Examination at Any Post-Therapy Visit as Compared to Baseline Assessment
Optic Nerve: Baseline Normal
|
6 participants
|
3 participants
|
5 participants
|
6 participants
|
5 participants
|
|
Number of Subjects With Change From Normal to Abnormal in Fundus Examination at Any Post-Therapy Visit as Compared to Baseline Assessment
Optic Nerve: Change from Normal to Abnormal
|
1 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline, Day 2, Day 4, Day 8, Day 15, Day 29, Day 57, Day 85Population: This analysis population includes all enrolled subjects who received investigational product.
A slit-lamp biomicroscopy examination was performed to evaluate the anterior segment of the eye. Subjects having a normal baseline evaluation were examined at subsequent visits, and any change from normal to abnormal was recorded. Criteria for reclassifying from normal to abnormal were left to the opinion of the investigators. One eye (study eye) contributed to the analysis. None of the abnormalities were deemed related to the study medication.
Outcome measures
| Measure |
CLG561, Level A
n=6 Participants
Single 50 μL intravitreal injection of CLG561, Dose Level A
|
CLG561, Level B
n=6 Participants
Single 50 μL intravitreal injection of CLG561, Dose Level B
|
CLG561, Level C
n=7 Participants
Single 50 μL intravitreal injection of CLG561, Dose Level C
|
CLG561, Level D
n=6 Participants
Single 50 μL intravitreal injection of CLG561, Dose Level D
|
CLG561, Level E
n=6 Participants
Single 100 μL intravitreal injection of CLG561, Dose Level E
|
|---|---|---|---|---|---|
|
Number of Subjects With a Change From Normal to Abnormal in Ocular Signs at Any Post-Therapy Visit as Compared to Baseline Assessment
Cornea: Change from Normal to Abnormal
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
1 participants
|
|
Number of Subjects With a Change From Normal to Abnormal in Ocular Signs at Any Post-Therapy Visit as Compared to Baseline Assessment
Iris: Baseline Normal
|
6 participants
|
6 participants
|
6 participants
|
6 participants
|
6 participants
|
|
Number of Subjects With a Change From Normal to Abnormal in Ocular Signs at Any Post-Therapy Visit as Compared to Baseline Assessment
Lids/Lashes: Baseline Normal
|
5 participants
|
4 participants
|
5 participants
|
6 participants
|
6 participants
|
|
Number of Subjects With a Change From Normal to Abnormal in Ocular Signs at Any Post-Therapy Visit as Compared to Baseline Assessment
Lids/Lashes: Change from Normal to Abnormal
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Number of Subjects With a Change From Normal to Abnormal in Ocular Signs at Any Post-Therapy Visit as Compared to Baseline Assessment
Conjunctiva: Baseline Normal
|
5 participants
|
4 participants
|
6 participants
|
5 participants
|
5 participants
|
|
Number of Subjects With a Change From Normal to Abnormal in Ocular Signs at Any Post-Therapy Visit as Compared to Baseline Assessment
Conjunctiva: Change from Normal to Abnormal
|
2 participants
|
1 participants
|
4 participants
|
0 participants
|
2 participants
|
|
Number of Subjects With a Change From Normal to Abnormal in Ocular Signs at Any Post-Therapy Visit as Compared to Baseline Assessment
Cornea: Baseline Normal
|
6 participants
|
5 participants
|
6 participants
|
6 participants
|
5 participants
|
|
Number of Subjects With a Change From Normal to Abnormal in Ocular Signs at Any Post-Therapy Visit as Compared to Baseline Assessment
Iris: Change from Normal to Abnormal
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85Population: This analysis population includes all subjects who received investigational product, completed at least 1 post-injection study visit and for whom serum concentration-time data is available, provided no collection or analytical deviations which would affect the integrity of the data occurred.
Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental pharmacokinetic (PK) method.
Outcome measures
| Measure |
CLG561, Level A
n=6 Participants
Single 50 μL intravitreal injection of CLG561, Dose Level A
|
CLG561, Level B
n=6 Participants
Single 50 μL intravitreal injection of CLG561, Dose Level B
|
CLG561, Level C
n=6 Participants
Single 50 μL intravitreal injection of CLG561, Dose Level C
|
CLG561, Level D
n=6 Participants
Single 50 μL intravitreal injection of CLG561, Dose Level D
|
CLG561, Level E
n=6 Participants
Single 100 μL intravitreal injection of CLG561, Dose Level E
|
|---|---|---|---|---|---|
|
Area Under the Serum Concentration-time Curve (AUC) From Time Zero to All [AUC(0-all)]
|
NA hr*ng/mL
Standard Deviation NA
Statistical analysis was not conducted because the concentration was too low to allow reliable estimation.
|
NA hr*ng/mL
Standard Deviation NA
Statistical analysis was not conducted because the concentration was too low to allow reliable estimation.
|
NA hr*ng/mL
Standard Deviation NA
Statistical analysis was not conducted because the concentration was too low to allow reliable estimation.
|
238000 hr*ng/mL
Standard Deviation 81800
|
373000 hr*ng/mL
Standard Deviation 160000
|
SECONDARY outcome
Timeframe: Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85Population: This analysis population includes all subjects who received investigational product, completed at least 1 post-injection study visit and for whom serum concentration-time data is available, provided no collection or analytical deviations which would affect the integrity of the data occurred.
Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental PK method.
Outcome measures
| Measure |
CLG561, Level A
n=6 Participants
Single 50 μL intravitreal injection of CLG561, Dose Level A
|
CLG561, Level B
n=6 Participants
Single 50 μL intravitreal injection of CLG561, Dose Level B
|
CLG561, Level C
n=6 Participants
Single 50 μL intravitreal injection of CLG561, Dose Level C
|
CLG561, Level D
n=6 Participants
Single 50 μL intravitreal injection of CLG561, Dose Level D
|
CLG561, Level E
n=6 Participants
Single 100 μL intravitreal injection of CLG561, Dose Level E
|
|---|---|---|---|---|---|
|
Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-last)]
|
NA hr*ng/mL
Standard Deviation NA
Statistical analysis was not conducted because the concentration was too low to allow reliable estimation.
|
NA hr*ng/mL
Standard Deviation NA
Statistical analysis was not conducted because the concentration was too low to allow reliable estimation.
|
NA hr*ng/mL
Standard Deviation NA
Statistical analysis was not conducted because the concentration was too low to allow reliable estimation.
|
195000 hr*ng/mL
Standard Deviation 78300
|
304000 hr*ng/mL
Standard Deviation 148000
|
SECONDARY outcome
Timeframe: Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85Population: This analysis population includes all subjects who received investigational product, completed at least 1 post-injection study visit and for whom serum concentration-time data is available, provided no collection or analytical deviations which would affect the integrity of the data occurred.
Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental PK method.
Outcome measures
| Measure |
CLG561, Level A
n=6 Participants
Single 50 μL intravitreal injection of CLG561, Dose Level A
|
CLG561, Level B
n=6 Participants
Single 50 μL intravitreal injection of CLG561, Dose Level B
|
CLG561, Level C
n=6 Participants
Single 50 μL intravitreal injection of CLG561, Dose Level C
|
CLG561, Level D
n=6 Participants
Single 50 μL intravitreal injection of CLG561, Dose Level D
|
CLG561, Level E
n=6 Participants
Single 100 μL intravitreal injection of CLG561, Dose Level E
|
|---|---|---|---|---|---|
|
Time to Reach the Maximum Serum Concentration After Drug Administration (Tmax)
|
NA hours
Standard Deviation NA
Statistical analysis was not conducted because the concentration was too low to allow reliable estimation.
|
NA hours
Standard Deviation NA
Statistical analysis was not conducted because the concentration was too low to allow reliable estimation.
|
NA hours
Standard Deviation NA
Statistical analysis was not conducted because the concentration was too low to allow reliable estimation.
|
144 hours
Standard Deviation 62.7
|
187 hours
Standard Deviation 79.8
|
SECONDARY outcome
Timeframe: Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85Population: This analysis population includes all subjects who received investigational product, completed at least 1 post-injection study visit and for whom serum concentration-time data is available, provided no collection or analytical deviations which would affect the integrity of the data occurred.
Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental PK method.
Outcome measures
| Measure |
CLG561, Level A
n=6 Participants
Single 50 μL intravitreal injection of CLG561, Dose Level A
|
CLG561, Level B
n=6 Participants
Single 50 μL intravitreal injection of CLG561, Dose Level B
|
CLG561, Level C
n=6 Participants
Single 50 μL intravitreal injection of CLG561, Dose Level C
|
CLG561, Level D
n=6 Participants
Single 50 μL intravitreal injection of CLG561, Dose Level D
|
CLG561, Level E
n=6 Participants
Single 100 μL intravitreal injection of CLG561, Dose Level E
|
|---|---|---|---|---|---|
|
Dose Normalized Observed Maximum Serum Concentration Following Drug Administration (Cmax/D)
|
NA ng/mL/mg
Standard Deviation NA
Statistical analysis was not conducted because the concentration was too low to allow reliable estimation.
|
NA ng/mL/mg
Standard Deviation NA
Statistical analysis was not conducted because the concentration was too low to allow reliable estimation.
|
NA ng/mL/mg
Standard Deviation NA
Statistical analysis was not conducted because the concentration was too low to allow reliable estimation.
|
102 ng/mL/mg
Standard Deviation 30
|
75.8 ng/mL/mg
Standard Deviation 30.9
|
SECONDARY outcome
Timeframe: Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85Population: This analysis population includes all subjects who received investigational product, completed at least 1 post-injection study visit and for whom serum concentration-time data is available, provided no collection or analytical deviations which would affect the integrity of the data occurred.
Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental PK method.
Outcome measures
| Measure |
CLG561, Level A
n=6 Participants
Single 50 μL intravitreal injection of CLG561, Dose Level A
|
CLG561, Level B
n=6 Participants
Single 50 μL intravitreal injection of CLG561, Dose Level B
|
CLG561, Level C
n=6 Participants
Single 50 μL intravitreal injection of CLG561, Dose Level C
|
CLG561, Level D
n=6 Participants
Single 50 μL intravitreal injection of CLG561, Dose Level D
|
CLG561, Level E
n=6 Participants
Single 100 μL intravitreal injection of CLG561, Dose Level E
|
|---|---|---|---|---|---|
|
Dose-normalized Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-last)/D]
|
NA hr*ng/mL/mg
Standard Deviation NA
Statistical analysis was not conducted because the concentration was too low to allow reliable estimation.
|
NA hr*ng/mL/mg
Standard Deviation NA
Statistical analysis was not conducted because the concentration was too low to allow reliable estimation.
|
NA hr*ng/mL/mg
Standard Deviation NA
Statistical analysis was not conducted because the concentration was too low to allow reliable estimation.
|
38900 hr*ng/mL/mg
Standard Deviation 15700
|
30400 hr*ng/mL/mg
Standard Deviation 14800
|
SECONDARY outcome
Timeframe: Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85Population: This parameter was not calculated as AUClast and AUCall were considered sufficient to characterize the systemic exposure to CLG561.
Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85Population: This parameter was not calculated as AUClast and AUCall were considered sufficient to characterize the systemic exposure to CLG561.
Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85Population: This parameter was not calculated as AUClast and AUCall were considered sufficient to characterize the systemic exposure to CLG561.
Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85Population: This parameter was not calculated as AUClast and AUCall were considered sufficient to characterize the systemic exposure to CLG561.
Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method.
Outcome measures
Outcome data not reported
Adverse Events
CLG561, Level A
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
CLG561, Level B
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
CLG561, Level C
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
CLG561, Level D
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
CLG561, Level E
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Pretreatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CLG561, Level A
n=6 participants at risk
Reported subsequent to the initiation of treatment
|
CLG561, Level B
n=6 participants at risk
Reported subsequent to the initiation of treatment
|
CLG561, Level C
n=7 participants at risk
Reported subsequent to the initiation of treatment
|
CLG561, Level D
n=6 participants at risk
Reported subsequent to the initiation of treatment
|
CLG561, Level E
n=6 participants at risk
Reported subsequent to the initiation of treatment
|
Pretreatment
n=50 participants at risk
Reported prior to the initiation of study treatment
|
|---|---|---|---|---|---|---|
|
Eye disorders
Blindness Transient
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
14.3%
1/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
Other adverse events
| Measure |
CLG561, Level A
n=6 participants at risk
Reported subsequent to the initiation of treatment
|
CLG561, Level B
n=6 participants at risk
Reported subsequent to the initiation of treatment
|
CLG561, Level C
n=7 participants at risk
Reported subsequent to the initiation of treatment
|
CLG561, Level D
n=6 participants at risk
Reported subsequent to the initiation of treatment
|
CLG561, Level E
n=6 participants at risk
Reported subsequent to the initiation of treatment
|
Pretreatment
n=50 participants at risk
Reported prior to the initiation of study treatment
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
14.3%
1/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Cardiac disorders
Heart valve incompetence
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
14.3%
1/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
14.3%
1/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Eye disorders
Arcus lipoides
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
14.3%
1/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Eye disorders
Conjunctival haemorrhage
|
50.0%
3/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
42.9%
3/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
28.6%
2/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Eye disorders
Conjunctivochalasis
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Eye disorders
Erythema of eyelid
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
28.6%
2/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Eye disorders
Eye discharge
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
14.3%
1/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Eye disorders
Eye pain
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Eye disorders
Eyelid cyst
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
14.3%
1/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Eye disorders
Eyelid margin crusting
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
14.3%
1/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
14.3%
1/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Eye disorders
Foreign body sensation in eyes
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Eye disorders
Lacrimal disorder
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
14.3%
1/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Eye disorders
Optic atrophy
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
28.6%
2/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Eye disorders
Optic disc disorder
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
14.3%
1/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Eye disorders
Punctate keratitis
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
42.9%
3/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
14.3%
1/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Eye disorders
Vitreal cells
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Eye disorders
Vitreous degeneration
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
14.3%
1/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
14.3%
1/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Eye disorders
Vitreous opacities
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
General disorders
Oedema peripheral
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
14.3%
1/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
14.3%
1/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
14.3%
1/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
14.3%
1/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Investigations
Amylase increased
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
33.3%
2/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Investigations
C-reactive protein increased
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Investigations
Crystal urine present
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Investigations
Lipase increased
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
33.3%
2/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
14.3%
1/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
14.3%
1/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
14.3%
1/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
14.3%
1/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Skin and subcutaneous tissue disorders
Cutis laxa
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Skin and subcutaneous tissue disorders
Madarosis
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
14.3%
1/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Skin and subcutaneous tissue disorders
Seborrhoea
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
14.3%
1/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
16.7%
1/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
14.3%
1/7 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/6 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
0.00%
0/50 • Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
|
Additional Information
Director, Translational Medicine Expert, Ophthalmology
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