Trial Outcomes & Findings for A Three Part Study of MGV354 in Ocular Hypertension or Glaucoma (NCT NCT02743780)
NCT ID: NCT02743780
Last Updated: 2018-07-02
Results Overview
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. Diurnal IOP was defined as the average of the five time points measured (8 AM, 10 AM, noon, 4 PM, and 8 PM). Baseline diurnal IOP was the average of IOP measurements obtained at the 2 eligibility visits. Change from baseline was calculated by taking the change at each time point from baseline to Day 8 and averaging the available changes. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye (study eye) contributed to the analysis.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
191 participants
Primary outcome timeframe
Baseline, Day 8
Results posted on
2018-07-02
Participant Flow
Subjects were recruited from 5 study centers located in the US.
This study was conducted in 3 parts. A separate cohort of subjects was enrolled for each part. Of the 191 subjects enrolled (Part 1, 2, and 3 combined), 79 were exited as screen failures and 14 were discontinued prior to randomization. This reporting group includes all randomized subjects. A zero indicates no intended subjects.
Participant milestones
| Measure |
MGV354 0.01%
MGV354 ophthalmic suspension 0.01%, 1 drop in the study eye (Part 1)
|
MGV354 0.03%
MGV354 ophthalmic suspension 0.03%, 1 drop in the study eye (Part 1) or 1 drop in each eye for 7 days (Part 2)
|
MGV354 0.1%
MGV354 ophthalmic suspension 0.1%, 1 drop in the study eye (Part 1) or 1 drop in each eye for 7 days (Part 2 and Part 3)
|
MGV354 0.3%
MGV354 ophthalmic suspension 0.3%, 1 drop in the study eye (Part 1)
|
Placebo
Placebo, 1 drop in the study eye (Part 1); 1 drop in each eye for 7 days (Part 2 and Part 3)
|
|---|---|---|---|---|---|
|
Part 1 (3 Days)
STARTED
|
6
|
6
|
6
|
6
|
8
|
|
Part 1 (3 Days)
COMPLETED
|
6
|
6
|
6
|
6
|
8
|
|
Part 1 (3 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Part 2 (8 Days)
STARTED
|
0
|
6
|
6
|
0
|
4
|
|
Part 2 (8 Days)
COMPLETED
|
0
|
6
|
6
|
0
|
4
|
|
Part 2 (8 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Part 3 (7 Days)
STARTED
|
0
|
0
|
25
|
0
|
25
|
|
Part 3 (7 Days)
COMPLETED
|
0
|
0
|
24
|
0
|
25
|
|
Part 3 (7 Days)
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
MGV354 0.01%
MGV354 ophthalmic suspension 0.01%, 1 drop in the study eye (Part 1)
|
MGV354 0.03%
MGV354 ophthalmic suspension 0.03%, 1 drop in the study eye (Part 1) or 1 drop in each eye for 7 days (Part 2)
|
MGV354 0.1%
MGV354 ophthalmic suspension 0.1%, 1 drop in the study eye (Part 1) or 1 drop in each eye for 7 days (Part 2 and Part 3)
|
MGV354 0.3%
MGV354 ophthalmic suspension 0.3%, 1 drop in the study eye (Part 1)
|
Placebo
Placebo, 1 drop in the study eye (Part 1); 1 drop in each eye for 7 days (Part 2 and Part 3)
|
|---|---|---|---|---|---|
|
Part 3 (7 Days)
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
This study was conducted in 3 parts.
Baseline characteristics by cohort
| Measure |
MGV354 0.01%
n=6 Participants
MGV354 ophthalmic suspension 0.01%, 1 drop in the study eye (Part 1)
|
MGV354 0.03%
n=12 Participants
MGV354 ophthalmic suspension 0.03%, 1 drop in the study eye (Part 1) or 1 drop in each eye for 7 days (Part 2)
|
MGV354 0.1%
n=36 Participants
MGV354 ophthalmic suspension 0.1%, 1 drop in the study eye (Part 1) or 1 drop in each eye for 7 days (Part 2 and Part 3)
|
MGV354 0.3%
n=6 Participants
MGV354 ophthalmic suspension 0.3%, 1 drop in the study eye (Part 1)
|
Placebo
n=37 Participants
Placebo, 1 drop in the study eye (Part 1); 1 drop in each eye for 7 days (Part 2 and Part 3)
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
Part 1
|
31.2 years
STANDARD_DEVIATION 13.61 • n=6 Participants • This study was conducted in 3 parts.
|
51.7 years
STANDARD_DEVIATION 15.77 • n=6 Participants • This study was conducted in 3 parts.
|
48.5 years
STANDARD_DEVIATION 17.55 • n=6 Participants • This study was conducted in 3 parts.
|
62.7 years
STANDARD_DEVIATION 7.74 • n=6 Participants • This study was conducted in 3 parts.
|
50.1 years
STANDARD_DEVIATION 7.51 • n=8 Participants • This study was conducted in 3 parts.
|
48.9 years
STANDARD_DEVIATION 15.54 • n=32 Participants • This study was conducted in 3 parts.
|
|
Age, Customized
Part 2
|
—
|
59.2 years
STANDARD_DEVIATION 7.52 • n=6 Participants • This study was conducted in 3 parts.
|
63.3 years
STANDARD_DEVIATION 7.79 • n=6 Participants • This study was conducted in 3 parts.
|
—
|
63.3 years
STANDARD_DEVIATION 6.70 • n=4 Participants • This study was conducted in 3 parts.
|
61.8 years
STANDARD_DEVIATION 7.23 • n=16 Participants • This study was conducted in 3 parts.
|
|
Age, Customized
Part 3
|
—
|
—
|
65.5 years
STANDARD_DEVIATION 8.17 • n=24 Participants • This study was conducted in 3 parts.
|
—
|
64.8 years
STANDARD_DEVIATION 9.92 • n=25 Participants • This study was conducted in 3 parts.
|
65.2 years
STANDARD_DEVIATION 9.02 • n=49 Participants • This study was conducted in 3 parts.
|
|
Sex/Gender, Customized
Female, Part 1
|
0 participants
n=6 Participants • This study was conducted in 3 parts.
|
5 participants
n=12 Participants • This study was conducted in 3 parts.
|
4 participants
n=36 Participants • This study was conducted in 3 parts.
|
6 participants
n=6 Participants • This study was conducted in 3 parts.
|
5 participants
n=37 Participants • This study was conducted in 3 parts.
|
20 participants
n=97 Participants • This study was conducted in 3 parts.
|
|
Sex/Gender, Customized
Male, Part 1
|
6 participants
n=6 Participants • This study was conducted in 3 parts.
|
1 participants
n=12 Participants • This study was conducted in 3 parts.
|
2 participants
n=36 Participants • This study was conducted in 3 parts.
|
0 participants
n=6 Participants • This study was conducted in 3 parts.
|
3 participants
n=37 Participants • This study was conducted in 3 parts.
|
12 participants
n=97 Participants • This study was conducted in 3 parts.
|
|
Sex/Gender, Customized
Female, Part 2
|
—
|
4 participants
n=12 Participants • This study was conducted in 3 parts.
|
3 participants
n=36 Participants • This study was conducted in 3 parts.
|
—
|
2 participants
n=37 Participants • This study was conducted in 3 parts.
|
9 participants
n=85 Participants • This study was conducted in 3 parts.
|
|
Sex/Gender, Customized
Male, Part 2
|
—
|
2 participants
n=12 Participants • This study was conducted in 3 parts.
|
3 participants
n=36 Participants • This study was conducted in 3 parts.
|
—
|
2 participants
n=37 Participants • This study was conducted in 3 parts.
|
7 participants
n=85 Participants • This study was conducted in 3 parts.
|
|
Sex/Gender, Customized
Female, Part 3
|
—
|
—
|
17 participants
n=36 Participants • This study was conducted in 3 parts.
|
—
|
17 participants
n=37 Participants • This study was conducted in 3 parts.
|
34 participants
n=73 Participants • This study was conducted in 3 parts.
|
|
Sex/Gender, Customized
Male, Part 3
|
—
|
—
|
7 participants
n=36 Participants • This study was conducted in 3 parts.
|
—
|
8 participants
n=37 Participants • This study was conducted in 3 parts.
|
15 participants
n=73 Participants • This study was conducted in 3 parts.
|
|
Intraocular Pressure (IOP)
Diurnal IOP
|
—
|
—
|
24.69 mmHg
STANDARD_DEVIATION 2.475 • n=24 Participants • IOP analysis was pre-specified for Part 3 subjects only.
|
—
|
24.63 mmHg
STANDARD_DEVIATION 2.119 • n=25 Participants • IOP analysis was pre-specified for Part 3 subjects only.
|
24.66 mmHg
STANDARD_DEVIATION 2.276 • n=49 Participants • IOP analysis was pre-specified for Part 3 subjects only.
|
|
Intraocular Pressure (IOP)
8 AM IOP
|
—
|
—
|
26.60 mmHg
STANDARD_DEVIATION 2.289 • n=24 Participants • IOP analysis was pre-specified for Part 3 subjects only.
|
—
|
27.33 mmHg
STANDARD_DEVIATION 3.300 • n=25 Participants • IOP analysis was pre-specified for Part 3 subjects only.
|
26.97 mmHg
STANDARD_DEVIATION 2.844 • n=49 Participants • IOP analysis was pre-specified for Part 3 subjects only.
|
|
Intraocular Pressure (IOP)
10 AM IOP
|
—
|
—
|
24.68 mmHg
STANDARD_DEVIATION 2.571 • n=24 Participants • IOP analysis was pre-specified for Part 3 subjects only.
|
—
|
24.77 mmHg
STANDARD_DEVIATION 1.976 • n=25 Participants • IOP analysis was pre-specified for Part 3 subjects only.
|
24.72 mmHg
STANDARD_DEVIATION 2.263 • n=49 Participants • IOP analysis was pre-specified for Part 3 subjects only.
|
|
Intraocular Pressure (IOP)
Noon IOP
|
—
|
—
|
24.46 mmHg
STANDARD_DEVIATION 2.842 • n=24 Participants • IOP analysis was pre-specified for Part 3 subjects only.
|
—
|
24.21 mmHg
STANDARD_DEVIATION 2.046 • n=25 Participants • IOP analysis was pre-specified for Part 3 subjects only.
|
24.33 mmHg
STANDARD_DEVIATION 2.445 • n=49 Participants • IOP analysis was pre-specified for Part 3 subjects only.
|
|
Intraocular Pressure (IOP)
4 PM IOP
|
—
|
—
|
24.39 mmHg
STANDARD_DEVIATION 2.521 • n=24 Participants • IOP analysis was pre-specified for Part 3 subjects only.
|
—
|
24.21 mmHg
STANDARD_DEVIATION 1.939 • n=25 Participants • IOP analysis was pre-specified for Part 3 subjects only.
|
24.30 mmHg
STANDARD_DEVIATION 2.221 • n=49 Participants • IOP analysis was pre-specified for Part 3 subjects only.
|
|
Intraocular Pressure (IOP)
8 PM IOP
|
—
|
—
|
23.34 mmHg
STANDARD_DEVIATION 2.998 • n=24 Participants • IOP analysis was pre-specified for Part 3 subjects only.
|
—
|
22.64 mmHg
STANDARD_DEVIATION 2.344 • n=25 Participants • IOP analysis was pre-specified for Part 3 subjects only.
|
22.98 mmHg
STANDARD_DEVIATION 2.680 • n=49 Participants • IOP analysis was pre-specified for Part 3 subjects only.
|
PRIMARY outcome
Timeframe: Baseline, Day 8Population: Full Analysis Set
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. Diurnal IOP was defined as the average of the five time points measured (8 AM, 10 AM, noon, 4 PM, and 8 PM). Baseline diurnal IOP was the average of IOP measurements obtained at the 2 eligibility visits. Change from baseline was calculated by taking the change at each time point from baseline to Day 8 and averaging the available changes. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
MGV354 0.1%
n=24 Participants
Part 3: MGV354 ophthalmic suspension, 1 drop in each eye for 7 days
|
Placebo
n=25 Participants
Part 3: MGV354 placebo, 1 drop in each eye for 7 days
|
MGV354 0.3%
Part 1: MGV354 0.3% ophthalmic suspension, 1 drop in the study eye
|
|---|---|---|---|
|
Part 3: Change in Diurnal IOP (Averaged Over 8 AM, 10 AM, Noon, 4 PM, and 8 PM) From Baseline to Day 8
|
-0.6 mmHg
Standard Error 0.43
|
-1.1 mmHg
Standard Error 0.42
|
—
|
PRIMARY outcome
Timeframe: Baseline, Day 8Population: Full Analysis Set
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. Baseline IOP was the average of IOP measurements obtained at the 2 eligibility visits. Change from baseline was calculated by taking the change at each time point from baseline to Day 8. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
MGV354 0.1%
n=24 Participants
Part 3: MGV354 ophthalmic suspension, 1 drop in each eye for 7 days
|
Placebo
n=25 Participants
Part 3: MGV354 placebo, 1 drop in each eye for 7 days
|
MGV354 0.3%
Part 1: MGV354 0.3% ophthalmic suspension, 1 drop in the study eye
|
|---|---|---|---|
|
Part 3: Change in IOP From Baseline to Day 8 at 8 AM, 10 AM, Noon, 4 PM, and 8 PM
Change from Baseline (BL) at 8 AM
|
0.1 mmHg
Standard Error 0.57
|
-1.5 mmHg
Standard Error 0.56
|
—
|
|
Part 3: Change in IOP From Baseline to Day 8 at 8 AM, 10 AM, Noon, 4 PM, and 8 PM
Change from BL at 10 AM
|
-0.4 mmHg
Standard Error 0.57
|
-1.5 mmHg
Standard Error 0.56
|
—
|
|
Part 3: Change in IOP From Baseline to Day 8 at 8 AM, 10 AM, Noon, 4 PM, and 8 PM
Change from BL at noon
|
-0.2 mmHg
Standard Error 0.57
|
-0.2 mmHg
Standard Error 0.56
|
—
|
|
Part 3: Change in IOP From Baseline to Day 8 at 8 AM, 10 AM, Noon, 4 PM, and 8 PM
Change from BL at 4 PM
|
-1.2 mmHg
Standard Error 0.57
|
-1.4 mmHg
Standard Error 0.56
|
—
|
|
Part 3: Change in IOP From Baseline to Day 8 at 8 AM, 10 AM, Noon, 4 PM, and 8 PM
Change from BL at 8 PM
|
-1.1 mmHg
Standard Error 0.57
|
-0.7 mmHg
Standard Error 0.56
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to Day 9Population: Full Analysis Set
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. Baseline IOP was the average of IOP measurements obtained at the 2 eligibility visits. Change from baseline was calculated by taking the change at each time point from baseline to Day 8 and averaging the available changes. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
MGV354 0.1%
n=24 Participants
Part 3: MGV354 ophthalmic suspension, 1 drop in each eye for 7 days
|
Placebo
n=25 Participants
Part 3: MGV354 placebo, 1 drop in each eye for 7 days
|
MGV354 0.3%
Part 1: MGV354 0.3% ophthalmic suspension, 1 drop in the study eye
|
|---|---|---|---|
|
Part 3: Change From Baseline in IOP at 36 Hours and 48 Hours Post Day 7 Administration
Change from Baseline at 36 hours post Day 7 dose
|
-1.58 mmHg
Standard Deviation 3.574
|
-1.09 mmHg
Standard Deviation 2.209
|
—
|
|
Part 3: Change From Baseline in IOP at 36 Hours and 48 Hours Post Day 7 Administration
Change from Baseline at 48 hours post Day 7 dose
|
-1.39 mmHg
Standard Deviation 3.282
|
-0.12 mmHg
Standard Deviation 2.541
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, .5, 2, 4, 6, 12, 24, 48, 72, 96, 120 hours post-dose, and Day 7 post-dosePopulation: This analysis population includes all subjects who received IP, had at least 1 plasma sample following exposure to non-placebo IP and had no known specimen collection or analytical deviations which would affect the integrity of the data (Pharmacokinetic (PK) Analysis Set). Number Analyzed is the number of subjects with data at visit.
Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was collected at each time point. Cmax is reported as mass/volume.
Outcome measures
| Measure |
MGV354 0.1%
n=3 Participants
Part 3: MGV354 ophthalmic suspension, 1 drop in each eye for 7 days
|
Placebo
n=6 Participants
Part 3: MGV354 placebo, 1 drop in each eye for 7 days
|
MGV354 0.3%
n=6 Participants
Part 1: MGV354 0.3% ophthalmic suspension, 1 drop in the study eye
|
|---|---|---|---|
|
Part 1: Maximum Observed Concentration [Cmax (ng/mL)]
|
0.073 ng/mL
Standard Deviation 0.013
|
0.098 ng/mL
Standard Deviation 0.032
|
0.327 ng/mL
Standard Deviation 0.178
|
SECONDARY outcome
Timeframe: Pre-dose, .5, 2, 4, 6, 12, 24, 48, 72, 96, 120 hours post-dose, and Day 7 post-dosePopulation: PK Analysis Set. Number Analyzed is the number of subjects with data at visit.
Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was collected at each time point.
Outcome measures
| Measure |
MGV354 0.1%
n=3 Participants
Part 3: MGV354 ophthalmic suspension, 1 drop in each eye for 7 days
|
Placebo
n=6 Participants
Part 3: MGV354 placebo, 1 drop in each eye for 7 days
|
MGV354 0.3%
n=6 Participants
Part 1: MGV354 0.3% ophthalmic suspension, 1 drop in the study eye
|
|---|---|---|---|
|
Part 1: Time to Reach Maximum Concentration [Tmax (h)]
|
0.483 hours
Interval 0.483 to 23.833
|
0.559 hours
Interval 0.5 to 2.033
|
0.575 hours
Interval 0.567 to 1.983
|
SECONDARY outcome
Timeframe: Pre-dose, .5, 2, 4, 6, 12, 24, 48, 72, 96, 120 hours post-dose, and Day 7 post-dosePopulation: PK Analysis Set. Number Analyzed is the number of subjects with data at visit.
Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was collected at each time point. AUClast is reported as mass\*time/volume.
Outcome measures
| Measure |
MGV354 0.1%
n=3 Participants
Part 3: MGV354 ophthalmic suspension, 1 drop in each eye for 7 days
|
Placebo
n=6 Participants
Part 3: MGV354 placebo, 1 drop in each eye for 7 days
|
MGV354 0.3%
n=6 Participants
Part 1: MGV354 0.3% ophthalmic suspension, 1 drop in the study eye
|
|---|---|---|---|
|
Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUClast (ng*h/mL)]
|
0.213 ng*h/mL
Standard Deviation 0.336
|
0.157 ng*h/mL
Standard Deviation 0.043
|
1.611 ng*h/mL
Standard Deviation 1.484
|
SECONDARY outcome
Timeframe: Pre-dose to 120 hours post-dosePopulation: Due to the low exposure and the limit of the lower limit of quantitation (LLOQ) (0.05 ng/mL), none of the observed individual profiles could generate valid AUC0-120.
Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was to be collected at each time point.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose to 120 hours post-dosePopulation: Due to the low exposure and the limit of LLOQ (0.05 ng/mL), none of the observed individual profiles could generate valid AUCinf.
Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was to be collected at each time point.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose to 120 hours post-dosePopulation: Due to the low exposure and the limit of LLOQ (0.05 ng/mL), none of the observed individual profiles could generate valid t1/2.
Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was to be collected at each time point.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Day 7Population: PK Analysis Set. Number Analyzed is the number of subjects with data at visit.
Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was collected at each time point. Cmax is reported as mass/volume.
Outcome measures
| Measure |
MGV354 0.1%
n=6 Participants
Part 3: MGV354 ophthalmic suspension, 1 drop in each eye for 7 days
|
Placebo
n=6 Participants
Part 3: MGV354 placebo, 1 drop in each eye for 7 days
|
MGV354 0.3%
Part 1: MGV354 0.3% ophthalmic suspension, 1 drop in the study eye
|
|---|---|---|---|
|
Part 2: Maximum Observed Concentration [Cmax (ng/mL)]
Day 1
|
0.077 ng/mL
Standard Deviation 0.026
|
0.139 ng/mL
Standard Deviation 0.034
|
—
|
|
Part 2: Maximum Observed Concentration [Cmax (ng/mL)]
Day 7
|
0.132 ng/mL
Standard Deviation 0.054
|
0.188 ng/mL
Standard Deviation 0.070
|
—
|
SECONDARY outcome
Timeframe: Up to Day 7Population: PK Analysis Set. Number Analyzed is the number of subjects with data at visit.
Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was collected at each time point.
Outcome measures
| Measure |
MGV354 0.1%
n=6 Participants
Part 3: MGV354 ophthalmic suspension, 1 drop in each eye for 7 days
|
Placebo
n=6 Participants
Part 3: MGV354 placebo, 1 drop in each eye for 7 days
|
MGV354 0.3%
Part 1: MGV354 0.3% ophthalmic suspension, 1 drop in the study eye
|
|---|---|---|---|
|
Part 2: Time to Reach Maximum Concentration [Tmax (h)]
Day 1
|
0.533 hours
Interval 0.5 to 0.583
|
0.567 hours
Interval 0.55 to 0.583
|
—
|
|
Part 2: Time to Reach Maximum Concentration [Tmax (h)]
Day 7
|
0.550 hours
Interval 0.483 to 0.55
|
0.533 hours
Interval 0.483 to 1.967
|
—
|
SECONDARY outcome
Timeframe: Up to Day 7Population: PK Analysis Set. Number Analyzed is the number of subjects with data at visit.
Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was collected at each time point. AUCtau is reported as mass\*time/volume.
Outcome measures
| Measure |
MGV354 0.1%
n=2 Participants
Part 3: MGV354 ophthalmic suspension, 1 drop in each eye for 7 days
|
Placebo
n=5 Participants
Part 3: MGV354 placebo, 1 drop in each eye for 7 days
|
MGV354 0.3%
Part 1: MGV354 0.3% ophthalmic suspension, 1 drop in the study eye
|
|---|---|---|---|
|
Part 2: Area Under the Concentration-time Curve From 0 to the End of the Dosing Interval Tau [AUCtau (ng*h/mL)]
Day 1
|
—
|
0.723 ng*h/mL
Standard Deviation NA
Not calculated when only 1 subject analyzed
|
—
|
|
Part 2: Area Under the Concentration-time Curve From 0 to the End of the Dosing Interval Tau [AUCtau (ng*h/mL)]
Day 7
|
0.392 ng*h/mL
Standard Deviation 0.444
|
1.461 ng*h/mL
Standard Deviation 1.043
|
—
|
SECONDARY outcome
Timeframe: Day 7Population: PK Analysis Set. Number Analyzed is the number of subjects with data at visit.
Accumulation Ratio was derived using Cmax on Day 7 versus Cmax on Day 1. Approximately 2 mL of venous blood was collected at each time point.
Outcome measures
| Measure |
MGV354 0.1%
n=3 Participants
Part 3: MGV354 ophthalmic suspension, 1 drop in each eye for 7 days
|
Placebo
n=5 Participants
Part 3: MGV354 placebo, 1 drop in each eye for 7 days
|
MGV354 0.3%
Part 1: MGV354 0.3% ophthalmic suspension, 1 drop in the study eye
|
|---|---|---|---|
|
Part 2: Accumulation Ratio (Racc)
|
1.893 ng/mL
Standard Deviation 1.038
|
1.391 ng/mL
Standard Deviation 0.366
|
—
|
SECONDARY outcome
Timeframe: Up to Day 8Population: PK Analysis Set. Number Analyzed is the number of subjects with data at visit.
Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was collected at each time point. C12 is reported as mass/volume.
Outcome measures
| Measure |
MGV354 0.1%
n=10 Participants
Part 3: MGV354 ophthalmic suspension, 1 drop in each eye for 7 days
|
Placebo
Part 3: MGV354 placebo, 1 drop in each eye for 7 days
|
MGV354 0.3%
Part 1: MGV354 0.3% ophthalmic suspension, 1 drop in the study eye
|
|---|---|---|---|
|
Part 3: Observed Concentration at 12 Hours Following Drug Administration [C12 (ng/mL)]
Day 2
|
0.0881 ng/mL
Standard Deviation 0.03964
|
—
|
—
|
|
Part 3: Observed Concentration at 12 Hours Following Drug Administration [C12 (ng/mL)]
Day 8
|
0.1488 ng/mL
Standard Deviation 0.11026
|
—
|
—
|
Adverse Events
MGV354 0.01% Part 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MGV354 0.03% Part 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MGV354 0.1% Part 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
MGV354 0.3% Part 1
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo Part 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MGV354 0.03% Part 2
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
MGV354 0.1% Part 2
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo Part 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
MGV354 0.1% Part 3
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Placebo Part 3
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MGV354 0.01% Part 1
n=6 participants at risk
1 drop in the study eye
|
MGV354 0.03% Part 1
n=6 participants at risk
1 drop in the study eye
|
MGV354 0.1% Part 1
n=6 participants at risk
1 drop in the study eye
|
MGV354 0.3% Part 1
n=6 participants at risk
1 drop in the study eye
|
Placebo Part 1
n=8 participants at risk
1 drop in the study eye
|
MGV354 0.03% Part 2
n=6 participants at risk
1 drop in each eye for 7 days
|
MGV354 0.1% Part 2
n=6 participants at risk
1 drop in each eye for 7 days
|
Placebo Part 2
n=4 participants at risk
1 drop in each eye for 7 days
|
MGV354 0.1% Part 3
n=25 participants at risk
1 drop in each eye for 7 days
|
Placebo Part 3
n=25 participants at risk
1 drop in each eye for 7 days
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
50.0%
3/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
100.0%
6/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/8 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
33.3%
2/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
100.0%
6/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/4 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
48.0%
12/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
4.0%
1/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
|
Eye disorders
Conjunctival oedema
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
66.7%
4/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/8 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
33.3%
2/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
16.7%
1/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/4 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
28.0%
7/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
8.0%
2/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
|
Eye disorders
Conjunctival cyst
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
16.7%
1/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/8 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/4 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
|
Eye disorders
Dry eye
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
16.7%
1/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/8 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/4 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
|
Eye disorders
Eye pruritus
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
16.7%
1/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/8 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
25.0%
1/4 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
16.7%
1/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/8 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/4 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
28.0%
7/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
16.7%
1/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/8 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/4 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
16.7%
1/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/8 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/4 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/8 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
66.7%
4/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/4 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
44.0%
11/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
12.0%
3/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/8 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
16.7%
1/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/4 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
|
Eye disorders
Eye irritation
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/8 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/4 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
16.0%
4/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/8 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/4 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
8.0%
2/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
0.00%
0/25 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (Part 1: up to 37 days, Part 2: up to 50 days, and Part 3: up to 59 days).
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects exposed to investigational product (Safety Analysis Set).
|
Additional Information
Translational Medicine Expert II, TM-Ophthalmic
Alcon, A Novartis Division
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