Trial Outcomes & Findings for A Study of the Drugs AGN-242428 and AGN-231868 in Participants With Dry Eye Disease (NCT NCT04030962)
NCT ID: NCT04030962
Last Updated: 2025-05-20
Results Overview
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
292 participants
Primary outcome timeframe
Day 1 to Day 15
Results posted on
2025-05-20
Participant Flow
In Stage 1, 48 participants at 2 sites in the US were randomized and treated (24 participants each in Cohorts 1A and 1B). In Stage 2, 244 subjects at 10 sites in the US were randomized and treated (49 subjects each in the AGN-242428 (High Dose), AGN-242428 vehicle, and AGN-231868 vehicle groups; 47 subjects in the AGN-231868 (High Dose); and 50 subjects in the Xiidra 5% group).
All safety analyses were performed on the safety population, which included all randomized participants who received at least 1 administration of study intervention (Stage 1, n=48; Stage 2, n=244). The pharmacokinetic population (Stage 1) included all participants with evaluable PK parameters in Stage 1. The pharmacokinetic population (Stage 2) included all participants with available plasma or tear concentrations in Stage 2.
Participant milestones
| Measure |
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 (High Dose)
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 2 Cohort 2: AGN-242428 (High Dose)
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received AGN-242428 (High dose). Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
|
Stage 2 Cohort 2: AGN-242428 Vehicle
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Vehicle. Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
|
Stage 2 Cohort 2: AGN-231868 (High Dose)
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received AGN-231868 (High dose). Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
|
Stage 2 Cohort 2: AGN-231868 Vehicle
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Vehicle. Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
|
Stage 2 Cohort 2: Xiidra (Lifitegrast Ophthalmic Solution)
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Xiidra (lifitegrast ophthalmic solution). Participants administered Xiidra (lifitegrast ophthalmic solution) in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1
STARTED
|
9
|
3
|
9
|
3
|
9
|
3
|
9
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1
COMPLETED
|
9
|
3
|
9
|
3
|
9
|
3
|
9
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
49
|
49
|
47
|
49
|
50
|
|
Stage 2
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
46
|
49
|
46
|
45
|
48
|
|
Stage 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
1
|
4
|
2
|
Reasons for withdrawal
| Measure |
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 (High Dose)
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 2 Cohort 2: AGN-242428 (High Dose)
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received AGN-242428 (High dose). Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
|
Stage 2 Cohort 2: AGN-242428 Vehicle
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Vehicle. Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
|
Stage 2 Cohort 2: AGN-231868 (High Dose)
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received AGN-231868 (High dose). Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
|
Stage 2 Cohort 2: AGN-231868 Vehicle
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Vehicle. Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
|
Stage 2 Cohort 2: Xiidra (Lifitegrast Ophthalmic Solution)
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Xiidra (lifitegrast ophthalmic solution). Participants administered Xiidra (lifitegrast ophthalmic solution) in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 2
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
1
|
1
|
|
Stage 2
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
2
|
1
|
|
Stage 2
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Stage 2
Technical Problems
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study of the Drugs AGN-242428 and AGN-231868 in Participants With Dry Eye Disease
Baseline characteristics by cohort
| Measure |
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
n=9 Participants
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-242428 Vehicle
n=3 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
n=9 Participants
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 Vehicle
n=3 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 (High Dose)
n=9 Participants
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 Vehicle
n=3 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 (High Dose)
n=9 Participants
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 Vehicle
n=3 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 2 Cohort 2: AGN-242428 (High Dose)
n=49 Participants
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received AGN-242428 (High dose). Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
|
Stage 2 Cohort 2: AGN-242428 Vehicle
n=49 Participants
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Vehicle. Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
|
Stage 2 Cohort 2: AGN-231868 (High Dose)
n=47 Participants
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received AGN-231868 (High dose). Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
|
Stage 2 Cohort 2: AGN-231868 Vehicle
n=49 Participants
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Vehicle. Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
|
Stage 2 Cohort 2: Xiidra (Lifitegrast Ophthalmic Solution)
n=50 Participants
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Xiidra (lifitegrast ophthalmic solution). Participants administered Xiidra (lifitegrast ophthalmic solution) in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
|
Total
n=292 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
64.4 years
STANDARD_DEVIATION 10.82 • n=5 Participants
|
71.7 years
STANDARD_DEVIATION 8.02 • n=7 Participants
|
65.0 years
STANDARD_DEVIATION 8.47 • n=5 Participants
|
65.3 years
STANDARD_DEVIATION 3.79 • n=4 Participants
|
60.0 years
STANDARD_DEVIATION 7.94 • n=21 Participants
|
71.0 years
STANDARD_DEVIATION 6.56 • n=8 Participants
|
68.7 years
STANDARD_DEVIATION 8.5 • n=8 Participants
|
68.7 years
STANDARD_DEVIATION 7.23 • n=24 Participants
|
60.7 years
STANDARD_DEVIATION 14.75 • n=42 Participants
|
64.0 years
STANDARD_DEVIATION 11.84 • n=42 Participants
|
65.2 years
STANDARD_DEVIATION 13.92 • n=42 Participants
|
63.1 years
STANDARD_DEVIATION 12.43 • n=42 Participants
|
63.3 years
STANDARD_DEVIATION 13.74 • n=36 Participants
|
63.6 years
STANDARD_DEVIATION 12.72 • n=36 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
36 Participants
n=42 Participants
|
37 Participants
n=42 Participants
|
34 Participants
n=42 Participants
|
30 Participants
n=42 Participants
|
35 Participants
n=36 Participants
|
205 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
13 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
19 Participants
n=42 Participants
|
15 Participants
n=36 Participants
|
87 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
10 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
45 Participants
n=42 Participants
|
48 Participants
n=42 Participants
|
45 Participants
n=42 Participants
|
48 Participants
n=42 Participants
|
49 Participants
n=36 Participants
|
282 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
5 Participants
n=36 Participants
|
28 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
12 Participants
n=36 Participants
|
53 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
37 Participants
n=42 Participants
|
31 Participants
n=42 Participants
|
36 Participants
n=42 Participants
|
33 Participants
n=42 Participants
|
33 Participants
n=36 Participants
|
204 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 15Population: Safety population (Stage 1; N=48)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Outcome measures
| Measure |
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
n=9 Participants
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-242428 Vehicle
n=3 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
n=9 Participants
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 Vehicle
n=3 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 (High Dose)
n=9 Participants
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 Vehicle
n=3 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 (High Dose)
n=9 Participants
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 Vehicle
n=3 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1: Number of Participants With Adverse Events
|
5 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 2 and Day 15 (Predose and up to 12 hours postdose)Population: PK Population (Stage 1; N=36).
Following single dose administration, the area under the plasma concentration versus time curves from time 0 to time of the last measurable concentration (AUC0-tlast; Visit 3) was calculated. Following repeat dose administration twice daily for 14 days, the area under the plasma concentration versus time curves from time 0 to the end of the dosing interval (AUC0-τ; Visit 5) was calculated. For Visit 3 and Visit 5, tlast was 12 hours post-dose.
Outcome measures
| Measure |
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
n=9 Participants
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-242428 Vehicle
n=9 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
n=9 Participants
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 Vehicle
n=9 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 (High Dose)
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1: Area Under the Plasma Concentration Versus Time Curves After Single and Repeat Dose Administration
Plasma Single Dose Administration: Day 2 (Visit 3)
|
NA pg•hr/mL
Standard Deviation NA
Concentration at Visit 3 was below limit of quantitation (\< 50 pg/mL)
|
2740 pg•hr/mL
Standard Deviation 2180
|
1430 pg•hr/mL
Standard Deviation 1300
|
32200 pg•hr/mL
Standard Deviation 26100
|
—
|
—
|
—
|
—
|
|
Stage 1: Area Under the Plasma Concentration Versus Time Curves After Single and Repeat Dose Administration
Plasma Repeat Dose Administration: Day 15 (Visit 5)
|
805 pg•hr/mL
Standard Deviation 509
|
3540 pg•hr/mL
Standard Deviation 2250
|
3790 pg•hr/mL
Standard Deviation 4410
|
37800 pg•hr/mL
Standard Deviation 20900
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 2 and Day 15 (Predose and up to 12 hours postdose)Population: PK Population (Stage 1; N=36). Data were not combined for both eyes from each subject but were calculated as separate 'N'.
Following single dose administration, the area under the tear concentration versus (vs) time curves from time 0 to time of the last measurable concentration (AUC0-tlast; Visit 3) was calculated. Following repeat dose administration twice daily for 14 days, the area under the tear concentration versus time curves from time 0 to the end of the dosing interval (AUC0-τ; Visit 5) was calculated. For Visit 3 and Visit 5, tlast was 12 hours post-dose.
Outcome measures
| Measure |
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
n=18 eyes
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-242428 Vehicle
n=18 eyes
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
n=18 eyes
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 Vehicle
n=18 eyes
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 (High Dose)
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1: Area Under the Tear Concentration Versus Time Curves After Single and Repeat Dose Administration
Tear Single Dose Administration: Day 2 (Visit 3)
|
3720 ng•hr/mL
Standard Deviation 5570
|
2530 ng•hr/mL
Standard Deviation 3060
|
7420 ng•hr/mL
Standard Deviation 6440
|
50900 ng•hr/mL
Standard Deviation 85500
|
—
|
—
|
—
|
—
|
|
Stage 1: Area Under the Tear Concentration Versus Time Curves After Single and Repeat Dose Administration
Tear Repeat Dose Administration: Day 15 (Visit 5)
|
14900 ng•hr/mL
Standard Deviation 39500
|
4540 ng•hr/mL
Standard Deviation 5730
|
15100 ng•hr/mL
Standard Deviation 19500
|
45400 ng•hr/mL
Standard Deviation 72900
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 2 and Day 15 (Predose and up to 12 hours postdose)Population: PK Population (Stage 1; N=36).
Following single dose administration, the plasma Cmax (Visit 3) was calculated. Following repeat dose administration twice daily for 14 days, the plasma Cmax (Visit 5) was calculated.
Outcome measures
| Measure |
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
n=9 Participants
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-242428 Vehicle
n=9 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
n=9 Participants
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 Vehicle
n=9 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 (High Dose)
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1: Maximum Plasma Drug Concentration (Cmax) After Single and Repeat Dose Administration
Plasma Single Dose Administration: Day 2 (Visit 3)
|
NA pg/mL
Standard Deviation NA
Concentration at Visit 3 was below limit of quantitation (BLQ; \< 50 pg/mL)
|
504 pg/mL
Standard Deviation 402
|
255 pg/mL
Standard Deviation 176
|
5790 pg/mL
Standard Deviation 4320
|
—
|
—
|
—
|
—
|
|
Stage 1: Maximum Plasma Drug Concentration (Cmax) After Single and Repeat Dose Administration
Plasma Repeat Dose Administration: Day 15 (Visit 5)
|
108 pg/mL
Standard Deviation 30
|
513 pg/mL
Standard Deviation 277
|
449 pg/mL
Standard Deviation 479
|
6460 pg/mL
Standard Deviation 2840
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 2 and Day 15 (Predose and up to 12 hours postdose)Population: PK Population (Stage 1; N=36). Data were not combined for both eyes from each subject but were calculated as separate 'N'.
Following single dose administration, the tear Cmax (Visit 3) was calculated. Following repeat dose administration twice daily for 14 days, the tear Cmax (Visit 5) was calculated.
Outcome measures
| Measure |
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
n=18 eyes
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-242428 Vehicle
n=18 eyes
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
n=18 eyes
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 Vehicle
n=18 eyes
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 (High Dose)
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1: Maximum Tear Drug Concentration (Cmax) After Single and Repeat Dose Administration
Tear Single Dose Administration: Day 2 (Visit 3)
|
1890 ng/mL
Standard Deviation 2780
|
1630 ng/mL
Standard Deviation 1780
|
3570 ng/mL
Standard Deviation 2810
|
17000 ng/mL
Standard Deviation 26300
|
—
|
—
|
—
|
—
|
|
Stage 1: Maximum Tear Drug Concentration (Cmax) After Single and Repeat Dose Administration
Tear Repeat Dose Administration: Day 15 (Visit 5)
|
5370 ng/mL
Standard Deviation 9550
|
2250 ng/mL
Standard Deviation 2940
|
6090 ng/mL
Standard Deviation 7120
|
17900 ng/mL
Standard Deviation 30400
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 2 and Day 15 (Predose and up to 12 hours postdose)Population: PK Population (Stage 1; N=36).
Following single dose administration, the plasma Tmax (Visit 3) was calculated. Following repeat dose administration twice daily for 14 days, the plasma Tmax (Visit 5) was calculated.
Outcome measures
| Measure |
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
n=9 Participants
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-242428 Vehicle
n=9 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
n=9 Participants
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 Vehicle
n=9 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 (High Dose)
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1: Time of Maximum Plasma Drug Concentration (Tmax) After Single and Repeat Dose Administration
Plasma Single Dose Administration: Day 2 (Visit 3)
|
NA hours
Standard Deviation 0.306
Concentration at Visit 3 was below limit of quantitation (\< 50 pg/mL)
|
1.75 hours
Standard Deviation 0.415
|
1.75 hours
Standard Deviation 1.17
|
1.75 hours
Standard Deviation 1.02
|
—
|
—
|
—
|
—
|
|
Stage 1: Time of Maximum Plasma Drug Concentration (Tmax) After Single and Repeat Dose Administration
Plasma Repeat Dose Administration: Day 15 (Visit 5)
|
1.92 hours
Standard Deviation 0.939
|
0.983 hours
Standard Deviation 1.04
|
1.78 hours
Standard Deviation 1.4
|
1.08 hours
Standard Deviation 0.499
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 2 and Day 15 (Predose and up to 12 hours postdose)Population: PK Population (Stage 1; N=36). Data were not combined for both eyes from each subject but were calculated as separate 'N'.
Following single dose administration, the tear Tmax (Visit 3) was calculated. Following repeat dose administration twice daily for 14 days, the tear Tmax (Visit 5) was calculated.
Outcome measures
| Measure |
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
n=18 eyes
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-242428 Vehicle
n=18 eyes
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
n=18 eyes
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 Vehicle
n=18 eyes
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 (High Dose)
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1: Time of Maximum Tear Drug Concentration (Tmax) After Single and Repeat Dose Administration
Tear Single Dose Administration: Day 2 (Visit 3)
|
0.592 hours
Standard Deviation 0.869
|
0.600 hours
Standard Deviation 2.28
|
0.575 hours
Standard Deviation 0.46
|
0.933 hours
Standard Deviation 1.95
|
—
|
—
|
—
|
—
|
|
Stage 1: Time of Maximum Tear Drug Concentration (Tmax) After Single and Repeat Dose Administration
Tear Repeat Dose Administration: Day 15 (Visit 5)
|
0.575 hours
Standard Deviation 0.077
|
0.550 hours
Standard Deviation 0.444
|
0.700 hours
Standard Deviation 0.824
|
0.742 hours
Standard Deviation 1.88
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 2 (Predose and up to 12 hours postdose).Population: PK Population (Stage 1; N=36). Data was available for all participants; however, T1/2 was reported only when Rsq\_adjusted ≥ 0.8, per the planned analysis. Number Analyzed for each timepoint includes only those participants with Rsq\_adjusted ≥ 0.8.
Following single dose administration, the plasma T1/2 (Day 2; Visit 3) was calculated.
Outcome measures
| Measure |
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
n=9 Participants
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-242428 Vehicle
n=7 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
n=3 Participants
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 Vehicle
n=7 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 (High Dose)
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1: Terminal Elimination Half-life of the Study Drugs (T1/2) in Plasma After Single Dose Administration
|
NA hours
Standard Deviation NA
Concentration at Visit 3 was below limit of quantitation (\< 50 pg/mL)
|
4.98 hours
Standard Deviation 0.939
|
6.09 hours
Standard Deviation 2.00
|
3.60 hours
Standard Deviation 0.893
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 15 (Predose and up to 12 hours postdose)Population: PK Population (Stage 1; N=36). Data was available for all participants; however, T1/2 was reported only when Rsq\_adjusted ≥ 0.8, per the planned analysis. Number Analyzed for each timepoint includes only those participants with Rsq\_adjusted ≥ 0.8.
Following repeat dose administration twice daily for 14 days, plasma T1/2 (Day 15; Visit 5) was calculated.
Outcome measures
| Measure |
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
n=3 Participants
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-242428 Vehicle
n=8 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
n=4 Participants
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 Vehicle
n=8 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 (High Dose)
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1: Terminal Elimination Half-life of the Study Drugs (T1/2) in Plasma After Repeat Dose Administration
|
16.2 hours
Standard Deviation 4.32
|
5.94 hours
Standard Deviation 1.72
|
11.5 hours
Standard Deviation 2.11
|
6.51 hours
Standard Deviation 4.43
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 2 and Day 15 (Predose and up to 12 hours postdose)Population: PK Population (Stage 1; N=36). Data were not combined for both eyes from each subject but were calculated as separate 'N'. Data was available for all participants; however, T1/2 was reported only when Rsq\_adjusted ≥ 0.8, per the planned analysis. Number Analyzed for each timepoint includes only those participants with Rsq\_adjusted ≥ 0.8.
Following single dose administration, the tear T1/2 (Visit 3) was calculated. Following repeat dose administration twice daily for 14 days, tear T1/2 (Visit 5) was calculated.
Outcome measures
| Measure |
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
n=18 eyes
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-242428 Vehicle
n=18 eyes
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
n=18 eyes
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 Vehicle
n=18 eyes
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 (High Dose)
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1: Terminal Elimination Half-life of the Study Drugs (T1/2) in Tear After Single and Repeat Dose Administration
Tear Single Dose Administration: Day 2 (Visit 3)
|
6.65 hours
Standard Deviation 6.28
|
4.76 hours
Standard Deviation 4.02
|
2.47 hours
Standard Deviation 0.883
|
2.59 hours
Standard Deviation 0.918
|
—
|
—
|
—
|
—
|
|
Stage 1: Terminal Elimination Half-life of the Study Drugs (T1/2) in Tear After Single and Repeat Dose Administration
Tear Repeat Dose Administration: Day 15 (Visit 5)
|
2.91 hours
Standard Deviation 1.29
|
3.24 hours
Standard Deviation 1.25
|
2.78 hours
Standard Deviation 1.48
|
2.66 hours
Standard Deviation 1.61
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 15 (Predose and up to 12 hours postdose)Population: PK Population (Stage 1; N=36). Data were not combined for both eyes from each subject but were calculated as separate 'N'.
Following repeat dose administration twice daily for 14 days, the tear Cmin,ss (Visit 5) was calculated.
Outcome measures
| Measure |
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
n=18 eyes
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-242428 Vehicle
n=18 eyes
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
n=18 eyes
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 Vehicle
n=18 eyes
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 (High Dose)
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1: Minimum Tear Drug Concentration at Steady State (Cmin,ss) After Repeat Dose Administration
|
1050 ng/mL
Standard Deviation 3760
|
171 ng/mL
Standard Deviation 331
|
677 ng/mL
Standard Deviation 1710
|
897 ng/mL
Standard Deviation 1670
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 15 (Predose and up to 12 hours postdose)Population: PK Population (Stage 1; N=36).
Following repeat dose administration twice daily for 14 days, the plasma Cmin,ss (Visit 5) was calculated.
Outcome measures
| Measure |
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
n=9 Participants
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-242428 Vehicle
n=9 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
n=9 Participants
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 Vehicle
n=9 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 (High Dose)
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1: Minimum Plasma Drug Concentration at Steady State (Cmin,ss) After Repeat Dose Administration
|
73.7 pg/mL
Standard Deviation 14.9
|
183 pg/mL
Standard Deviation 115
|
237 pg/mL
Standard Deviation 281
|
1650 pg/mL
Standard Deviation 1320
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 15 (up to 12 hours) / Day 1 (up to 12 hours)Population: PK Population (Stage 1; N=36).
Following repeat dose administration, the mean plasma and tear AI(area under curve \[AUC\]) was calculated. AI(AUC) is reported as the ratio of exposure (AUC) at steady state (Day 15) to the exposure after a single daily dose (Day 1). Values greater than one are indicative of drug accumulation with repeat dosing.
Outcome measures
| Measure |
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
n=9 Participants
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-242428 Vehicle
n=9 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
n=9 Participants
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 Vehicle
n=9 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 (High Dose)
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1: Mean Accumulation Index of Drug Concentration (AI) After Repeat Dose Administration
Plasma
|
NA ratio
Standard Deviation NA
All concentrations at Visit 3 were BLQ
|
1.50 ratio
Standard Deviation 0.68
|
2.94 ratio
Standard Deviation 1.83
|
1.90 ratio
Standard Deviation 1.82
|
—
|
—
|
—
|
—
|
|
Stage 1: Mean Accumulation Index of Drug Concentration (AI) After Repeat Dose Administration
Tear
|
3.53 ratio
Standard Deviation 3.97
|
5.04 ratio
Standard Deviation 8.36
|
2.13 ratio
Standard Deviation 2.15
|
1.53 ratio
Standard Deviation 0.90
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 15Population: Safety Population
Acute overall tolerability attributes of study interventions on an 8-question visual analog scale (VAS) Drop Tolerability Questionnaire. Visual scale ranges from 0 = not at all comfortable to 100 = very comfortable. Higher mean scores indicate higher levels of comfort with the assigned intervention.
Outcome measures
| Measure |
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
n=9 Participants
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-242428 Vehicle
n=3 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
n=9 Participants
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 Vehicle
n=3 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 (High Dose)
n=9 Participants
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 Vehicle
n=3 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 (High Dose)
n=9 Participants
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 Vehicle
n=3 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1: Mean Drop Tolerability Questionnaire Scores
How comfortable are the study eye drops in your eyes?
|
72.4 score on a scale
Standard Deviation 14.65
|
68.0 score on a scale
Standard Deviation 41.87
|
89.8 score on a scale
Standard Deviation 9.93
|
84.0 score on a scale
Standard Deviation 17.09
|
57.6 score on a scale
Standard Deviation 23.50
|
72.3 score on a scale
Standard Deviation 23.46
|
77.2 score on a scale
Standard Deviation 21.29
|
62.0 score on a scale
Standard Deviation 11.14
|
|
Stage 1: Mean Drop Tolerability Questionnaire Scores
How soothing are the study eye drops in your eyes?
|
71.8 score on a scale
Standard Deviation 11.76
|
71.7 score on a scale
Standard Deviation 42.16
|
88.6 score on a scale
Standard Deviation 10.00
|
86.7 score on a scale
Standard Deviation 12.50
|
59.0 score on a scale
Standard Deviation 22.78
|
76.7 score on a scale
Standard Deviation 13.58
|
77.9 score on a scale
Standard Deviation 16.87
|
58.7 score on a scale
Standard Deviation 19.86
|
|
Stage 1: Mean Drop Tolerability Questionnaire Scores
How moistening/lubricating are the study eye drops in your eyes?
|
71.6 score on a scale
Standard Deviation 9.62
|
89.3 score on a scale
Standard Deviation 11.59
|
86.3 score on a scale
Standard Deviation 14.04
|
87.7 score on a scale
Standard Deviation 10.79
|
64.1 score on a scale
Standard Deviation 19.12
|
69.3 score on a scale
Standard Deviation 11.93
|
76.4 score on a scale
Standard Deviation 13.24
|
62.3 score on a scale
Standard Deviation 18.72
|
|
Stage 1: Mean Drop Tolerability Questionnaire Scores
How clear is your vision with the study eye drops in your eyes?
|
67.4 score on a scale
Standard Deviation 11.19
|
67.7 score on a scale
Standard Deviation 45.65
|
73.1 score on a scale
Standard Deviation 29.16
|
71.3 score on a scale
Standard Deviation 17.79
|
46.8 score on a scale
Standard Deviation 20.50
|
63.3 score on a scale
Standard Deviation 14.22
|
67.3 score on a scale
Standard Deviation 21.67
|
56.0 score on a scale
Standard Deviation 21.93
|
|
Stage 1: Mean Drop Tolerability Questionnaire Scores
How much stickiness do you have with the study eye drops in your eyes?
|
68.0 score on a scale
Standard Deviation 16.73
|
69.0 score on a scale
Standard Deviation 46.77
|
76.9 score on a scale
Standard Deviation 29.68
|
84.0 score on a scale
Standard Deviation 5.20
|
70.8 score on a scale
Standard Deviation 17.71
|
76.0 score on a scale
Standard Deviation 12.77
|
71.6 score on a scale
Standard Deviation 27.55
|
66.0 score on a scale
Standard Deviation 21.07
|
|
Stage 1: Mean Drop Tolerability Questionnaire Scores
How much blur do you have with the study eye drops in your eyes?
|
60.8 score on a scale
Standard Deviation 21.31
|
68.7 score on a scale
Standard Deviation 46.48
|
74.1 score on a scale
Standard Deviation 30.06
|
71.7 score on a scale
Standard Deviation 14.57
|
57.0 score on a scale
Standard Deviation 23.26
|
55.0 score on a scale
Standard Deviation 32.19
|
61.2 score on a scale
Standard Deviation 24.42
|
61.7 score on a scale
Standard Deviation 25.58
|
|
Stage 1: Mean Drop Tolerability Questionnaire Scores
How much burning/stinging do you have with the study eye drops in your eyes?
|
68.6 score on a scale
Standard Deviation 22.04
|
76.0 score on a scale
Standard Deviation 33.81
|
81.3 score on a scale
Standard Deviation 27.73
|
83.0 score on a scale
Standard Deviation 14.80
|
56.3 score on a scale
Standard Deviation 27.78
|
67.3 score on a scale
Standard Deviation 30.44
|
74.0 score on a scale
Standard Deviation 22.87
|
75.0 score on a scale
Standard Deviation 17.58
|
|
Stage 1: Mean Drop Tolerability Questionnaire Scores
How much discomfort do you have with the study eye drops in your eyes?
|
77.8 score on a scale
Standard Deviation 7.69
|
70.0 score on a scale
Standard Deviation 38.43
|
79.1 score on a scale
Standard Deviation 28.16
|
89.3 score on a scale
Standard Deviation 7.37
|
57.6 score on a scale
Standard Deviation 20.88
|
76.3 score on a scale
Standard Deviation 22.81
|
70.8 score on a scale
Standard Deviation 25.99
|
73.3 score on a scale
Standard Deviation 14.01
|
PRIMARY outcome
Timeframe: Day 1 to Day 15Population: Safety Population. Analysis included participants with a non-PCS baseline value and at least one post-baseline assessment.
The percentage of participants with non-PCS baseline value and met PCS criterion at least once postbaseline for clinical laboratory values.
Outcome measures
| Measure |
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
n=9 Participants
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-242428 Vehicle
n=3 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
n=9 Participants
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 Vehicle
n=3 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 (High Dose)
n=9 Participants
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 Vehicle
n=3 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 (High Dose)
n=9 Participants
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 Vehicle
n=3 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1: Percentage of Participants Who Met Criteria for Potentially Clinically Significant (PCS) Clinical Laboratory Values
Protein (Urinalysis) (>= 2+)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Stage 1: Percentage of Participants Who Met Criteria for Potentially Clinically Significant (PCS) Clinical Laboratory Values
Eosinophils (10^9/L) (> 1.5 * upper limit of normal [ULN])
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Stage 1: Percentage of Participants Who Met Criteria for Potentially Clinically Significant (PCS) Clinical Laboratory Values
Hematocrit (Ratio) (< 0.8 * lower limit of normal (LLN) or >= 1.2 * ULN)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Stage 1: Percentage of Participants Who Met Criteria for Potentially Clinically Significant (PCS) Clinical Laboratory Values
Hemoglobin (g/L) (< 0.8 * LLN or >= 1.2 * ULN)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Stage 1: Percentage of Participants Who Met Criteria for Potentially Clinically Significant (PCS) Clinical Laboratory Values
Erythrocytes (10^12/L) (< 0.8 * LLN or > 1.2 * ULN)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Stage 1: Percentage of Participants Who Met Criteria for Potentially Clinically Significant (PCS) Clinical Laboratory Values
Leukocytes (10^9/L) (< 0.7 * LLN or > 1.8 * ULN)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Stage 1: Percentage of Participants Who Met Criteria for Potentially Clinically Significant (PCS) Clinical Laboratory Values
Lymphocytes (10^9/L) (< 0.8 * LLN or > 1.2 * ULN)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Stage 1: Percentage of Participants Who Met Criteria for Potentially Clinically Significant (PCS) Clinical Laboratory Values
Neutrophils (10^9/L) (< 0.6 * LLN or > 1.6 * ULN)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Stage 1: Percentage of Participants Who Met Criteria for Potentially Clinically Significant (PCS) Clinical Laboratory Values
Platelets (10^9/L) (< 0.5 * LLN or > 1.5 * ULN)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Stage 1: Percentage of Participants Who Met Criteria for Potentially Clinically Significant (PCS) Clinical Laboratory Values
Albumin (g/L) (< 0.9 * LLN or > 1.1 * ULN)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Stage 1: Percentage of Participants Who Met Criteria for Potentially Clinically Significant (PCS) Clinical Laboratory Values
Alkaline Phosphatase (U/L) (> 3.0 * ULN)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Stage 1: Percentage of Participants Who Met Criteria for Potentially Clinically Significant (PCS) Clinical Laboratory Values
Alanine Aminotransferase (U/L) (> 3.0 * ULN)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Stage 1: Percentage of Participants Who Met Criteria for Potentially Clinically Significant (PCS) Clinical Laboratory Values
Aspartate Aminotransferase (U/L) (> 3.0 * ULN)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Stage 1: Percentage of Participants Who Met Criteria for Potentially Clinically Significant (PCS) Clinical Laboratory Values
Calcium (mmol/L) (< 0.9 * LLN or > 1.1 * ULN)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Stage 1: Percentage of Participants Who Met Criteria for Potentially Clinically Significant (PCS) Clinical Laboratory Values
Bilirubin (umol/L) (> 1.5 * ULN)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Stage 1: Percentage of Participants Who Met Criteria for Potentially Clinically Significant (PCS) Clinical Laboratory Values
Glucose Fasting (mmol/L) (< 0.8 * LLN or > 1.2 * ULN)
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Stage 1: Percentage of Participants Who Met Criteria for Potentially Clinically Significant (PCS) Clinical Laboratory Values
Cholesterol (mmol/L) (> 1.2 * ULN)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Stage 1: Percentage of Participants Who Met Criteria for Potentially Clinically Significant (PCS) Clinical Laboratory Values
Protein (g/L) (< 0.9 * LLN or > 1.1 * ULN)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Stage 1: Percentage of Participants Who Met Criteria for Potentially Clinically Significant (PCS) Clinical Laboratory Values
Creatinine (umol/L) (> 1.8 * ULN)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Stage 1: Percentage of Participants Who Met Criteria for Potentially Clinically Significant (PCS) Clinical Laboratory Values
Potassium (mmol/L) (< 0.9 * LLN or > 1.1 * ULN)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Stage 1: Percentage of Participants Who Met Criteria for Potentially Clinically Significant (PCS) Clinical Laboratory Values
Sodium (mmol/L) (< 0.9 * LLN or > 1.1 * ULN)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Stage 1: Percentage of Participants Who Met Criteria for Potentially Clinically Significant (PCS) Clinical Laboratory Values
Urea Nitrogen (mmol/L) (> 1.3 * ULN)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Stage 1: Percentage of Participants Who Met Criteria for Potentially Clinically Significant (PCS) Clinical Laboratory Values
pH (Urinalysis) (< 0.9 * LLN or > 1.1 * ULN)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Stage 1: Percentage of Participants Who Met Criteria for Potentially Clinically Significant (PCS) Clinical Laboratory Values
Specific Gravity (Urinalysis) (> 1.1 * ULN)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 15Population: Safety Population
The percentage of participants who met PCS criteria at least once postbaseline for vital sign values (sitting systolic and diastolic blood pressure, pulse rate, weight, respiration rate, and temperature)
Outcome measures
| Measure |
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
n=9 Participants
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-242428 Vehicle
n=3 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
n=9 Participants
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 Vehicle
n=3 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 (High Dose)
n=9 Participants
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 Vehicle
n=3 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 (High Dose)
n=9 Participants
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 Vehicle
n=3 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1: Percentage of Participants Who Met Criteria for PCS Vital Sign Values (Blood Pressure, Pulse Rate, Weight, Respiration Rate, and Temperature)
Systolic Blood Pressure (mmHg) (<=90 and Decrease of >=20 or >=180 and Increase of >=20)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Stage 1: Percentage of Participants Who Met Criteria for PCS Vital Sign Values (Blood Pressure, Pulse Rate, Weight, Respiration Rate, and Temperature)
Diastolic Blood Pressure (mmHg) (<=50 and Decrease of >=15 or >=105 and Increase of >=15)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Stage 1: Percentage of Participants Who Met Criteria for PCS Vital Sign Values (Blood Pressure, Pulse Rate, Weight, Respiration Rate, and Temperature)
Pulse Rate (beats/min) (<=50 and Decrease of >=15 or >=120 and Increase of >=15
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Stage 1: Percentage of Participants Who Met Criteria for PCS Vital Sign Values (Blood Pressure, Pulse Rate, Weight, Respiration Rate, and Temperature)
Weight (kg) Decrease of >=7% or Increase of >=7%
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Stage 1: Percentage of Participants Who Met Criteria for PCS Vital Sign Values (Blood Pressure, Pulse Rate, Weight, Respiration Rate, and Temperature)
Respiratory Rate (breaths/min) (<=8 or >=28)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Stage 1: Percentage of Participants Who Met Criteria for PCS Vital Sign Values (Blood Pressure, Pulse Rate, Weight, Respiration Rate, and Temperature)
Temperature (C) (<35 or >38)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 15Population: Safety Population
The percentage of participants with PCS postbaseline (but not at baseline) ECG values for QRS interval, PR interval, and QTc (Fridericia)
Outcome measures
| Measure |
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
n=9 Participants
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-242428 Vehicle
n=3 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
n=9 Participants
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 Vehicle
n=3 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 (High Dose)
n=9 Participants
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 Vehicle
n=3 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 (High Dose)
n=9 Participants
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 Vehicle
n=3 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1: Percentage of Participants Who Met Criteria for PCS Electrocardiogram (ECG) Values
QRS Interval (msec) actual value of >=150
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Stage 1: Percentage of Participants Who Met Criteria for PCS Electrocardiogram (ECG) Values
PR Interval (msec) actual value of >=250
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Stage 1: Percentage of Participants Who Met Criteria for PCS Electrocardiogram (ECG) Values
QTc Fridericia (msec) actual value of > 500 or Increase of > 60
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 15Population: Safety Population
At least 2 measurements were taken by qualified study site personnel using a Goldmann applanation tonometer affixed to a slit lamp with the participant seated.
Outcome measures
| Measure |
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
n=9 Participants
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-242428 Vehicle
n=3 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
n=9 Participants
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 Vehicle
n=3 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 (High Dose)
n=9 Participants
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 Vehicle
n=3 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 (High Dose)
n=9 Participants
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 Vehicle
n=3 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1: Mean Change From Baseline in Intraocular Pressure (IOP)
Day 2: Right eye
|
-1.06 mmHg
Standard Deviation 1.782
|
0.67 mmHg
Standard Deviation 1.528
|
-0.44 mmHg
Standard Deviation 3.005
|
0.33 mmHg
Standard Deviation 1.528
|
0.11 mmHg
Standard Deviation 2.837
|
-0.17 mmHg
Standard Deviation 1.443
|
-0.17 mmHg
Standard Deviation 2.385
|
-1.83 mmHg
Standard Deviation 2.021
|
|
Stage 1: Mean Change From Baseline in Intraocular Pressure (IOP)
Day 2: Left eye
|
-1.75 mmHg
Standard Deviation 2.053
|
1.00 mmHg
Standard Deviation 2.000
|
0.22 mmHg
Standard Deviation 3.270
|
0.33 mmHg
Standard Deviation 2.309
|
-0.67 mmHg
Standard Deviation 2.905
|
-0.50 mmHg
Standard Deviation 0.500
|
0.33 mmHg
Standard Deviation 2.107
|
-1.67 mmHg
Standard Deviation 1.155
|
|
Stage 1: Mean Change From Baseline in Intraocular Pressure (IOP)
Day 8: Right eye
|
0.17 mmHg
Standard Deviation 2.291
|
-1.33 mmHg
Standard Deviation 1.155
|
0.11 mmHg
Standard Deviation 2.804
|
-1.17 mmHg
Standard Deviation 2.021
|
0.33 mmHg
Standard Deviation 2.236
|
0.17 mmHg
Standard Deviation 2.021
|
0.33 mmHg
Standard Deviation 3.132
|
1.17 mmHg
Standard Deviation 0.764
|
|
Stage 1: Mean Change From Baseline in Intraocular Pressure (IOP)
Day 8: Left eye
|
0.00 mmHg
Standard Deviation 2.062
|
-0.67 mmHg
Standard Deviation 1.528
|
0.56 mmHg
Standard Deviation 2.920
|
-1.00 mmHg
Standard Deviation 2.646
|
0.50 mmHg
Standard Deviation 2.872
|
0.17 mmHg
Standard Deviation 0.289
|
0.61 mmHg
Standard Deviation 2.607
|
1.33 mmHg
Standard Deviation 0.764
|
|
Stage 1: Mean Change From Baseline in Intraocular Pressure (IOP)
Day 15: Right eye
|
-1.17 mmHg
Standard Deviation 1.620
|
-2.67 mmHg
Standard Deviation 3.055
|
-1.11 mmHg
Standard Deviation 1.691
|
-0.33 mmHg
Standard Deviation 1.155
|
-1.00 mmHg
Standard Deviation 2.739
|
-3.33 mmHg
Standard Deviation 1.155
|
-0.28 mmHg
Standard Deviation 2.123
|
0.33 mmHg
Standard Deviation 1.155
|
|
Stage 1: Mean Change From Baseline in Intraocular Pressure (IOP)
Day 15: Left eye
|
-1.44 mmHg
Standard Deviation 1.810
|
-0.67 mmHg
Standard Deviation 2.082
|
-0.44 mmHg
Standard Deviation 1.590
|
-0.33 mmHg
Standard Deviation 2.082
|
-1.00 mmHg
Standard Deviation 3.527
|
-2.67 mmHg
Standard Deviation 1.155
|
-0.06 mmHg
Standard Deviation 2.157
|
0.33 mmHg
Standard Deviation 1.528
|
PRIMARY outcome
Timeframe: Day 1 to Day 15Population: Safety Population
BCVA was quantified using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity protocol.
Outcome measures
| Measure |
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
n=9 Participants
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-242428 Vehicle
n=3 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
n=9 Participants
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 Vehicle
n=3 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 (High Dose)
n=9 Participants
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 Vehicle
n=3 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 (High Dose)
n=9 Participants
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 Vehicle
n=3 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1: Mean Change From Baseline in Best-corrected Visual Acuity (BCVA)
Day 2: Left eye
|
0.8 letters
Standard Deviation 4.71
|
1.0 letters
Standard Deviation 4.58
|
0.1 letters
Standard Deviation 3.22
|
-4.7 letters
Standard Deviation 3.79
|
-1.1 letters
Standard Deviation 2.26
|
0.3 letters
Standard Deviation 0.58
|
0.6 letters
Standard Deviation 2.07
|
1.3 letters
Standard Deviation 2.31
|
|
Stage 1: Mean Change From Baseline in Best-corrected Visual Acuity (BCVA)
Day 8: Right eye
|
-2.1 letters
Standard Deviation 3.55
|
0.3 letters
Standard Deviation 1.15
|
-0.4 letters
Standard Deviation 1.74
|
-0.3 letters
Standard Deviation 2.08
|
1.1 letters
Standard Deviation 3.52
|
2.7 letters
Standard Deviation 3.51
|
0.8 letters
Standard Deviation 1.79
|
-1.0 letters
Standard Deviation 1.00
|
|
Stage 1: Mean Change From Baseline in Best-corrected Visual Acuity (BCVA)
Day 8: Left eye
|
1.2 letters
Standard Deviation 4.18
|
2.7 letters
Standard Deviation 5.69
|
-0.7 letters
Standard Deviation 2.40
|
-0.3 letters
Standard Deviation 0.58
|
0.7 letters
Standard Deviation 2.00
|
-1.3 letters
Standard Deviation 2.52
|
-0.4 letters
Standard Deviation 1.13
|
2.7 letters
Standard Deviation 4.04
|
|
Stage 1: Mean Change From Baseline in Best-corrected Visual Acuity (BCVA)
Day 15: Right eye
|
-0.9 letters
Standard Deviation 2.47
|
0.3 letters
Standard Deviation 0.58
|
-2.3 letters
Standard Deviation 3.39
|
-0.3 letters
Standard Deviation 3.21
|
2.0 letters
Standard Deviation 2.35
|
1.7 letters
Standard Deviation 3.79
|
1.2 letters
Standard Deviation 1.92
|
-0.7 letters
Standard Deviation 1.15
|
|
Stage 1: Mean Change From Baseline in Best-corrected Visual Acuity (BCVA)
Day 15: Left eye
|
0.3 letters
Standard Deviation 0.87
|
1.0 letters
Standard Deviation 3.61
|
-1.0 letters
Standard Deviation 3.00
|
-3.0 letters
Standard Deviation 1.73
|
0.8 letters
Standard Deviation 2.11
|
-1.7 letters
Standard Deviation 1.53
|
0.3 letters
Standard Deviation 2.24
|
1.7 letters
Standard Deviation 1.53
|
|
Stage 1: Mean Change From Baseline in Best-corrected Visual Acuity (BCVA)
Day 2: Right eye
|
-0.9 letters
Standard Deviation 2.10
|
0.3 letters
Standard Deviation 1.53
|
-0.1 letters
Standard Deviation 1.96
|
-1.7 letters
Standard Deviation 2.31
|
-0.6 letters
Standard Deviation 2.83
|
3.3 letters
Standard Deviation 3.21
|
0.0 letters
Standard Deviation 2.29
|
-3.7 letters
Standard Deviation 3.06
|
PRIMARY outcome
Timeframe: Day 1 to Day 15Population: Safety Population
The number of participants with any ophthalmoscopy findings of any severity increase from baseline at one or more visit.
Outcome measures
| Measure |
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
n=9 Participants
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-242428 Vehicle
n=3 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
n=9 Participants
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 Vehicle
n=3 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 (High Dose)
n=9 Participants
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 Vehicle
n=3 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 (High Dose)
n=9 Participants
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 Vehicle
n=3 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1: Biomicroscopy: Percentage of Participants With Any Severity Increase From Baseline
Right eye
|
7 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
6 Participants
|
3 Participants
|
|
Stage 1: Biomicroscopy: Percentage of Participants With Any Severity Increase From Baseline
Left eye
|
5 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 15Population: Safety Population
The fundus (posterior pole; periphery, when dilated) was evaluated for pathology. Ophthalmoscopy with clinically significant findings (per investigator assessment) postbaseline are reported.
Outcome measures
| Measure |
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
n=9 Participants
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-242428 Vehicle
n=3 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
n=9 Participants
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 Vehicle
n=3 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 (High Dose)
n=9 Participants
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 Vehicle
n=3 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 (High Dose)
n=9 Participants
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 Vehicle
n=3 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1: Percentage of Participants With Any Clinically Significant Postbaseline Findings During Dilated Fundus Examination
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 42Population: Safety Population
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Outcome measures
| Measure |
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
n=49 Participants
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-242428 Vehicle
n=49 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
n=47 Participants
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 Vehicle
n=49 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 (High Dose)
n=50 Participants
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
|---|---|---|---|---|---|---|---|---|
|
Stage 2: Number of Participants With Adverse Events
|
21 Participants
|
22 Participants
|
18 Participants
|
10 Participants
|
25 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 42Population: Safety Population. The numerator for the incidence is the number of participants with non-PCS baseline and at least one post-baseline value meeting the specific criterion at the visit. The denominator is the number of participants with non-PCS baseline and at least one post-baseline assessment at the visit. If a participant did not have a baseline value, but met the criterion post-baseline, then the participant is counted in the numerator.
The percentage of participants who have PCS postbaseline clinical laboratory values at Day 42 (Visit 6).
Outcome measures
| Measure |
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
n=49 Participants
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-242428 Vehicle
n=49 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
n=47 Participants
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 Vehicle
n=49 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 (High Dose)
n=50 Participants
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
|---|---|---|---|---|---|---|---|---|
|
Stage 2: Percentage of Participants With Potentially Clinically Significant (PCS) Clinical Laboratory Values
Eosinophils (10^9/L) (> 1.5 * upper limit of normal [ULN])
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Percentage of Participants With Potentially Clinically Significant (PCS) Clinical Laboratory Values
Hematocrit (%) (Low: < 0.8 x LLN or High: >= 1.2 x ULN)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Percentage of Participants With Potentially Clinically Significant (PCS) Clinical Laboratory Values
Hemoglobin (g/L) (< 0.8 * LLN or >= 1.2 * ULN)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Percentage of Participants With Potentially Clinically Significant (PCS) Clinical Laboratory Values
Lymphocytes (10^9/L) (< 0.8 * LLN or > 1.2 * ULN)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Percentage of Participants With Potentially Clinically Significant (PCS) Clinical Laboratory Values
Neutrophils (10^9/L) (< 0.6 * LLN or > 1.6 * ULN)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Percentage of Participants With Potentially Clinically Significant (PCS) Clinical Laboratory Values
Platelets (10^9/L) (< 0.5 * LLN or > 1.5 * ULN)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Percentage of Participants With Potentially Clinically Significant (PCS) Clinical Laboratory Values
Red blood cells (10^12/L) (< 0.8 * LLN or > 1.2 * ULN)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Percentage of Participants With Potentially Clinically Significant (PCS) Clinical Laboratory Values
White blood cells (10^9/L) (< 0.7 * LLN or > 1.8 * ULN)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Percentage of Participants With Potentially Clinically Significant (PCS) Clinical Laboratory Values
Alanine Aminotransferase (U/L) (> 3.0 * ULN)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Percentage of Participants With Potentially Clinically Significant (PCS) Clinical Laboratory Values
Albumin (g/L) (< 0.9 * LLN or > 1.1 * ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Percentage of Participants With Potentially Clinically Significant (PCS) Clinical Laboratory Values
Alkaline Phosphatase (U/L) (> 3.0 * ULN)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Percentage of Participants With Potentially Clinically Significant (PCS) Clinical Laboratory Values
Aspartate Aminotransferase (U/L) (> 3.0 * ULN)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Percentage of Participants With Potentially Clinically Significant (PCS) Clinical Laboratory Values
Bilirubin (umol/L) (> 1.5 * ULN)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Percentage of Participants With Potentially Clinically Significant (PCS) Clinical Laboratory Values
Blood Urea Nitrogen (mmol/L) (> 1.3 * ULN)
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Percentage of Participants With Potentially Clinically Significant (PCS) Clinical Laboratory Values
Calcium (mmol/L) (< 0.9 * LLN or > 1.1 * ULN)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Percentage of Participants With Potentially Clinically Significant (PCS) Clinical Laboratory Values
Cholesterol (mmol/L) (> 1.2 * ULN)
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Stage 2: Percentage of Participants With Potentially Clinically Significant (PCS) Clinical Laboratory Values
Creatinine (umol/L) (> 1.8 * ULN)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Percentage of Participants With Potentially Clinically Significant (PCS) Clinical Laboratory Values
Glucose (mmol/L) (< 0.8 * LLN or > 1.4 * ULN)
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Stage 2: Percentage of Participants With Potentially Clinically Significant (PCS) Clinical Laboratory Values
Potassium (mmol/L) (< 0.9 * LLN or > 1.1 * ULN)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Percentage of Participants With Potentially Clinically Significant (PCS) Clinical Laboratory Values
Protein (g/L) (< 0.9 * LLN or > 1.1 * ULN)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Percentage of Participants With Potentially Clinically Significant (PCS) Clinical Laboratory Values
Sodium (mmol/L) (< 0.9 * LLN or > 1.1 * ULN)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Percentage of Participants With Potentially Clinically Significant (PCS) Clinical Laboratory Values
Glucose (Urinalysis) (>= 2+)
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Percentage of Participants With Potentially Clinically Significant (PCS) Clinical Laboratory Values
pH (Urinalysis) (< 0.9 * LLN or > 1.1 * ULN)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Percentage of Participants With Potentially Clinically Significant (PCS) Clinical Laboratory Values
Protein (Urinalysis) (>= 2+)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Percentage of Participants With Potentially Clinically Significant (PCS) Clinical Laboratory Values
Specific Gravity (Urinalysis) (> 1.1 * ULN)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 42Population: Safety Population. The Overall Number Analyzed for each arm refers to the overall number of participants with data available for the given assessment.
The percentage of participants who met PCS criteria at least once postbaseline for vital sign values at Day 42 (Visit 6) (sitting systolic and diastolic blood pressure, pulse rate, weight, respiration rate, and temperature). The numerator for the incidence is the number of participants with non-PCS baseline and at least one post-baseline value meeting the specific criterion at the visit. The denominator is the number of participants with non-PCS baseline and at least one post-baseline assessment at the visit. If a participant did not have a baseline value, but met the criterion post-baseline, then the participant is counted in the numerator.
Outcome measures
| Measure |
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
n=45 Participants
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-242428 Vehicle
n=49 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
n=46 Participants
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 Vehicle
n=44 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 (High Dose)
n=48 Participants
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
|---|---|---|---|---|---|---|---|---|
|
Stage 2: Percentage of Participants Who Met Criteria for PCS Vital Sign Values (Blood Pressure, Pulse Rate, Weight, Respiration Rate, and Temperature)
Systolic: High (Actual Value >= 180 mmHg and Change from baseline Increase of >= 20 mmHg)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Percentage of Participants Who Met Criteria for PCS Vital Sign Values (Blood Pressure, Pulse Rate, Weight, Respiration Rate, and Temperature)
Systolic: Low (Actual Value <= 90 mmHg and Change from baseline decrease of >= 20 mmHg)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Percentage of Participants Who Met Criteria for PCS Vital Sign Values (Blood Pressure, Pulse Rate, Weight, Respiration Rate, and Temperature)
Diastolic: High (Actual Value >= 105 mmHg and Change from baseline increase of >= 15 mmHg)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Percentage of Participants Who Met Criteria for PCS Vital Sign Values (Blood Pressure, Pulse Rate, Weight, Respiration Rate, and Temperature)
Diastolic: Low (Actual Value <= 50 mmHg and Change from baseline Increase of >= 15 mmHg)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Percentage of Participants Who Met Criteria for PCS Vital Sign Values (Blood Pressure, Pulse Rate, Weight, Respiration Rate, and Temperature)
Sitting Pulse Rate (BPM) High (Actual Value >=120 and Change from baseline increase >=15)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Percentage of Participants Who Met Criteria for PCS Vital Sign Values (Blood Pressure, Pulse Rate, Weight, Respiration Rate, and Temperature)
Sitting Pulse Rate (BPM) Low (Actual Value <= 50 and Change from baseline decrease of >= 15)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Percentage of Participants Who Met Criteria for PCS Vital Sign Values (Blood Pressure, Pulse Rate, Weight, Respiration Rate, and Temperature)
Weight (kg) (High [Change from baseline Increase >=7%] or Low (Change from baseline Decrease >=7%)]
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Stage 2: Percentage of Participants Who Met Criteria for PCS Vital Sign Values (Blood Pressure, Pulse Rate, Weight, Respiration Rate, and Temperature)
Respiratory rate (BPM) (High [Actual Value >= 28] or Low [Actual Value <= 8])
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Percentage of Participants Who Met Criteria for PCS Vital Sign Values (Blood Pressure, Pulse Rate, Weight, Respiration Rate, and Temperature)
Temperature (C) (High [Actual Value >38] or Low [Actual Value <35])
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 42Population: Safety Population. The Overall Number Analyzed for each arm refers to the overall number of participants with data available for the given assessment.
The percentage of participants who have PCS ECG at Visit 6 (but not baseline) pre and post-controlled adverse environment (CAE). The numerator for the incidence is the number of participants with non-PCS baseline and at least one post-baseline value meeting the specific criterion at the visit. The denominator is the number of participants with non-PCS baseline and at least one post-baseline assessment at the visit. If a participant did not have a baseline value, but met the criterion post-baseline, then the participant is counted in the numerator.
Outcome measures
| Measure |
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
n=19 Participants
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-242428 Vehicle
n=22 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
n=21 Participants
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 Vehicle
n=19 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 (High Dose)
n=21 Participants
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
|---|---|---|---|---|---|---|---|---|
|
Stage 2: Percentage of Participants Who Met Criteria for PCS Electrocardiogram (ECG) Values
Pre-CAE: QRS Interval (msec) actual value of >=150
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Percentage of Participants Who Met Criteria for PCS Electrocardiogram (ECG) Values
Post-CAE: QRS Interval (msec) actual value of >=150
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Stage 2: Percentage of Participants Who Met Criteria for PCS Electrocardiogram (ECG) Values
Pre-CAE: PR Interval (msec) actual value of >=250
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Percentage of Participants Who Met Criteria for PCS Electrocardiogram (ECG) Values
Post-CAE: PR Interval (msec) actual value of >=250
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Percentage of Participants Who Met Criteria for PCS Electrocardiogram (ECG) Values
Pre-CAE: QTc Fridericia (msec) actual value of > 500
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Percentage of Participants Who Met Criteria for PCS Electrocardiogram (ECG) Values
Post-CAE: QTc Fridericia (msec) actual value of > 500
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Percentage of Participants Who Met Criteria for PCS Electrocardiogram (ECG) Values
Pre-CAE: QTc Fridericia (msec) Increase of > 60
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Percentage of Participants Who Met Criteria for PCS Electrocardiogram (ECG) Values
Post-CAE: QTc Fridericia (msec) Increase of > 60
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1, Day 42Population: Safety Population
At least 2 IOP measurements were taken by qualified study site personnel using a Goldmann applanation tonometer affixed to a slit lamp with the participant seated. Average intraocular pressure = mean of the 2 (or 3) measures in the study eye and non-study eye. Total fluorescein scores and Schirmer values were used to determine the study eye, and if both eyes qualified, the right eye was designated by default.
Outcome measures
| Measure |
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
n=49 Participants
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-242428 Vehicle
n=49 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
n=47 Participants
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 Vehicle
n=49 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 (High Dose)
n=50 Participants
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
|---|---|---|---|---|---|---|---|---|
|
Stage 2: Mean Change From Baseline in Intraocular Pressure (IOP)
Study eye
|
0.7 mmHg
Standard Deviation 2.37
|
0.2 mmHg
Standard Deviation 2.65
|
-0.5 mmHg
Standard Deviation 2.57
|
0.2 mmHg
Standard Deviation 2.05
|
-0.1 mmHg
Standard Deviation 2.37
|
—
|
—
|
—
|
|
Stage 2: Mean Change From Baseline in Intraocular Pressure (IOP)
Non-study eye
|
0.9 mmHg
Standard Deviation 2.23
|
0.3 mmHg
Standard Deviation 2.58
|
-0.6 mmHg
Standard Deviation 2.56
|
0.5 mmHg
Standard Deviation 2.48
|
0.3 mmHg
Standard Deviation 2.49
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1, Day 42Population: Safety Population
BCVA was quantified using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity protocol in the study eye and the non-study eye. Total fluorescein scores and Schirmer values were used to determine the study eye, and if both eyes qualified, the right eye was designated by default.
Outcome measures
| Measure |
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
n=49 Participants
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-242428 Vehicle
n=49 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
n=47 Participants
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 Vehicle
n=49 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 (High Dose)
n=50 Participants
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
|---|---|---|---|---|---|---|---|---|
|
Stage 2: Mean Change From Baseline in Best-corrected Visual Acuity (BCVA)
Study eye
|
0.7 letters
Standard Deviation 3.96
|
1.2 letters
Standard Deviation 4.16
|
0.5 letters
Standard Deviation 4.13
|
0.9 letters
Standard Deviation 2.80
|
1.4 letters
Standard Deviation 4.11
|
—
|
—
|
—
|
|
Stage 2: Mean Change From Baseline in Best-corrected Visual Acuity (BCVA)
Non-study eye
|
-0.0 letters
Standard Deviation 4.02
|
0.3 letters
Standard Deviation 3.35
|
0.3 letters
Standard Deviation 6.26
|
0.4 letters
Standard Deviation 3.68
|
1.1 letters
Standard Deviation 4.23
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 42Population: Safety Population
Percentage of participants with a clinically significant finding postbaseline, post-CAE. A clinically significant finding is defined as more than one severity grade increase (worsening) from baseline or positive status change from absence at baseline to presence at postbaseline (not associated with a severity grade) in one or both eyes.
Outcome measures
| Measure |
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
n=49 Participants
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-242428 Vehicle
n=49 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
n=47 Participants
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 Vehicle
n=49 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 (High Dose)
n=50 Participants
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
|---|---|---|---|---|---|---|---|---|
|
Stage 2: Slit-lamp Biomicroscopy: Percentage of Participants With Any Clinically Significant Finding Postbaseline
|
9 Participants
|
16 Participants
|
10 Participants
|
8 Participants
|
14 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 42Population: Safety Population
The fundus (posterior pole; periphery, when dilated) was evaluated for pathology. Ophthalmoscopy with clinically significant findings (per investigator assessment) postbaseline are reported.
Outcome measures
| Measure |
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
n=49 Participants
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-242428 Vehicle
n=49 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
n=47 Participants
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 Vehicle
n=49 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 (High Dose)
n=50 Participants
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
|---|---|---|---|---|---|---|---|---|
|
Stage 2: Percentage of Participants With Any Clinically Significant Postbaseline Findings During Dilated Fundus Examination
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 42 (Post-CAE)Population: Safety Population
Acute overall tolerability attributes of study interventions on an 8-question visual analog scale (VAS) Drop Tolerability Questionnaire. Participants completed questionnaires after exposure to a controlled adverse environment (CAE) for approximately 90 minutes. Visual scale ranges from 0 = not at all comfortable to 100 = very comfortable. Higher mean scores indicate higher levels of comfort with the assigned intervention.
Outcome measures
| Measure |
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
n=49 Participants
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-242428 Vehicle
n=49 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
n=47 Participants
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 Vehicle
n=49 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 (High Dose)
n=50 Participants
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
|---|---|---|---|---|---|---|---|---|
|
Stage 2: Drop Tolerability Questionnaire Score (Post-controlled Adverse Environment)
How comfortable are the study eye drops in your eyes?
|
50.9 score on a scale
Standard Deviation 32.71
|
64.2 score on a scale
Standard Deviation 27.75
|
69.3 score on a scale
Standard Deviation 24.12
|
82.9 score on a scale
Standard Deviation 16.68
|
58.5 score on a scale
Standard Deviation 28.18
|
—
|
—
|
—
|
|
Stage 2: Drop Tolerability Questionnaire Score (Post-controlled Adverse Environment)
How soothing are the study eye drops in your eyes?
|
49.5 score on a scale
Standard Deviation 30.94
|
62.2 score on a scale
Standard Deviation 27.28
|
67.4 score on a scale
Standard Deviation 24.99
|
80.1 score on a scale
Standard Deviation 18.78
|
55.1 score on a scale
Standard Deviation 30.36
|
—
|
—
|
—
|
|
Stage 2: Drop Tolerability Questionnaire Score (Post-controlled Adverse Environment)
How moistening/lubricating are the study eye drops in your eyes?
|
58.2 score on a scale
Standard Deviation 28.5
|
67.3 score on a scale
Standard Deviation 21.25
|
70.2 score on a scale
Standard Deviation 20.21
|
78.4 score on a scale
Standard Deviation 18.05
|
61.8 score on a scale
Standard Deviation 27.39
|
—
|
—
|
—
|
|
Stage 2: Drop Tolerability Questionnaire Score (Post-controlled Adverse Environment)
How clear is your vision with the study eye drops in your eyes?
|
60.0 score on a scale
Standard Deviation 30.25
|
68.7 score on a scale
Standard Deviation 22.57
|
66.0 score on a scale
Standard Deviation 23.24
|
77.4 score on a scale
Standard Deviation 18.50
|
51.6 score on a scale
Standard Deviation 30.86
|
—
|
—
|
—
|
|
Stage 2: Drop Tolerability Questionnaire Score (Post-controlled Adverse Environment)
How much stickiness do you have with the study eye drops in your eyes?
|
75.8 score on a scale
Standard Deviation 24.52
|
68.2 score on a scale
Standard Deviation 27.37
|
62.5 score on a scale
Standard Deviation 30.42
|
73.3 score on a scale
Standard Deviation 31.55
|
58.2 score on a scale
Standard Deviation 31.19
|
—
|
—
|
—
|
|
Stage 2: Drop Tolerability Questionnaire Score (Post-controlled Adverse Environment)
How much blur do you have with the study eye drops in your eyes?
|
60.7 score on a scale
Standard Deviation 32.55
|
58.4 score on a scale
Standard Deviation 29.91
|
58.5 score on a scale
Standard Deviation 28.68
|
72.8 score on a scale
Standard Deviation 26.25
|
47.7 score on a scale
Standard Deviation 31.38
|
—
|
—
|
—
|
|
Stage 2: Drop Tolerability Questionnaire Score (Post-controlled Adverse Environment)
How much burning/stinging do you have with the study eye drops in your eyes?
|
47.9 score on a scale
Standard Deviation 36.42
|
52.1 score on a scale
Standard Deviation 34.02
|
54.5 score on a scale
Standard Deviation 32.20
|
69.3 score on a scale
Standard Deviation 32.19
|
45.0 score on a scale
Standard Deviation 33.36
|
—
|
—
|
—
|
|
Stage 2: Drop Tolerability Questionnaire Score (Post-controlled Adverse Environment)
How much discomfort do you have with the study eye drops in your eyes?
|
55.5 score on a scale
Standard Deviation 31.52
|
60.6 score on a scale
Standard Deviation 30.35
|
61.8 score on a scale
Standard Deviation 30.78
|
73.2 score on a scale
Standard Deviation 29.42
|
50.4 score on a scale
Standard Deviation 32.18
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 42Population: PK population (Stage 2). In Stage 2, post-dose trough plasma concentrations of AGN-242428 or AGN-231868 only were assessed as planned using descriptive statistics.
Trough plasma concentration (Ctrough) and plasma concentration at 0.5 hours postdose (C0.5h), following twice daily dosing for up to 6 weeks
Outcome measures
| Measure |
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
n=49 Participants
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-242428 Vehicle
n=47 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 (High Dose)
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
|---|---|---|---|---|---|---|---|---|
|
Stage 2: Trough Plasma Concentration (Ctrough) and Plasma Concentration at 0.5 Hours Postdose (C0.5h)
Predose or Ctrough
|
329 pg/mL
Standard Deviation 369
|
1810 pg/mL
Standard Deviation 1950
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Stage 2: Trough Plasma Concentration (Ctrough) and Plasma Concentration at 0.5 Hours Postdose (C0.5h)
C0.5h
|
444 pg/mL
Standard Deviation 349
|
6300 pg/mL
Standard Deviation 3650
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 42Population: PK population (Stage 2)
Trough tear concentration (Ctrough) and tear concentration at 0.5 hours postdose (C0.5h), following twice daily dosing for up to 6 weeks
Outcome measures
| Measure |
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
n=49 Participants
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-242428 Vehicle
n=47 Participants
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
n=50 Participants
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 (High Dose)
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
|---|---|---|---|---|---|---|---|---|
|
Stage 2: Trough Tear Concentration (Ctrough) and Tear Concentration at 0.5 Hours Postdose (C0.5h)
Predose Ctrough
|
310 ng/mL
Standard Deviation 782
|
1270 ng/mL
Standard Deviation 3560
|
12000 ng/mL
Standard Deviation 17600
|
—
|
—
|
—
|
—
|
—
|
|
Stage 2: Trough Tear Concentration (Ctrough) and Tear Concentration at 0.5 Hours Postdose (C0.5h)
C0.5h
|
13200 ng/mL
Standard Deviation 31400
|
13700 ng/mL
Standard Deviation 28000
|
1030000 ng/mL
Standard Deviation 1710000
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Stage 1 Cohort 1A: AGN-242428 Vehicle
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Stage 1 Cohort 1A: AGN-231868 Vehicle
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Stage 1 Cohort 1B: AGN-242428 (High Dose)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Stage 1 Cohort 1B: AGN-242428 Vehicle
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Stage 1 Cohort 1B: AGN-231868 Vehicle
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stage 2 Cohort 2: AGN-242428 (High Dose)
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Stage 2 Cohort 2: AGN-242428 Vehicle
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Stage 2 Cohort 2: AGN-231868 (High Dose)
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Stage 2 Cohort 2: AGN-231868 Vehicle
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Stage 2 Cohort 2: Xiidra (Lifitegrast Ophthalmic Solution)
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
n=9 participants at risk
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-242428 Vehicle
n=3 participants at risk
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
n=9 participants at risk
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 Vehicle
n=3 participants at risk
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 (High Dose)
n=9 participants at risk
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 Vehicle
n=3 participants at risk
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 (High Dose)
n=9 participants at risk
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5)
|
Stage 1 Cohort 1B: AGN-231868 Vehicle
n=3 participants at risk
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 2 Cohort 2: AGN-242428 (High Dose)
n=49 participants at risk
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received AGN-242428 (High dose). Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
|
Stage 2 Cohort 2: AGN-242428 Vehicle
n=49 participants at risk
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Vehicle. Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
|
Stage 2 Cohort 2: AGN-231868 (High Dose)
n=47 participants at risk
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received AGN-231868 (High dose). Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42
|
Stage 2 Cohort 2: AGN-231868 Vehicle
n=49 participants at risk
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Vehicle. Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
|
Stage 2 Cohort 2: Xiidra (Lifitegrast Ophthalmic Solution)
n=50 participants at risk
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Xiidra (lifitegrast ophthalmic solution). Participants administered Xiidra (lifitegrast ophthalmic solution) in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
MITRAL VALVE DISEASE MIXED
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/49 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/49 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
2.1%
1/47 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/49 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/50 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/49 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/49 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/47 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
2.0%
1/49 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/50 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LYMPHOMA
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/49 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/49 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/47 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
2.0%
1/49 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/50 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
|
Vascular disorders
AORTIC STENOSIS
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/49 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/49 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
2.1%
1/47 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/49 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/50 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
Other adverse events
| Measure |
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
n=9 participants at risk
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-242428 Vehicle
n=3 participants at risk
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
n=9 participants at risk
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1A: AGN-231868 Vehicle
n=3 participants at risk
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 (High Dose)
n=9 participants at risk
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-242428 Vehicle
n=3 participants at risk
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 1 Cohort 1B: AGN-231868 (High Dose)
n=9 participants at risk
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5)
|
Stage 1 Cohort 1B: AGN-231868 Vehicle
n=3 participants at risk
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
|
Stage 2 Cohort 2: AGN-242428 (High Dose)
n=49 participants at risk
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received AGN-242428 (High dose). Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
|
Stage 2 Cohort 2: AGN-242428 Vehicle
n=49 participants at risk
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Vehicle. Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
|
Stage 2 Cohort 2: AGN-231868 (High Dose)
n=47 participants at risk
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received AGN-231868 (High dose). Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42
|
Stage 2 Cohort 2: AGN-231868 Vehicle
n=49 participants at risk
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Vehicle. Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
|
Stage 2 Cohort 2: Xiidra (Lifitegrast Ophthalmic Solution)
n=50 participants at risk
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Xiidra (lifitegrast ophthalmic solution). Participants administered Xiidra (lifitegrast ophthalmic solution) in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
EAR INFECTION
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/49 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/49 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/47 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/49 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/50 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
|
Infections and infestations
HERPES ZOSTER
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/49 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/49 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/47 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/49 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/50 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
|
Eye disorders
CATARACT
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/49 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/49 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/47 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/49 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/50 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
|
Eye disorders
CONJUNCTIVAL HYPERAEMIA
|
22.2%
2/9 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
33.3%
3/9 • Number of events 3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/49 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/49 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/47 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/49 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/50 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
|
Eye disorders
EYE IRRITATION
|
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
28.6%
14/49 • Number of events 15 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
26.5%
13/49 • Number of events 13 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
8.5%
4/47 • Number of events 4 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
2.0%
1/49 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
26.0%
13/50 • Number of events 13 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
|
Eye disorders
EYE PAIN
|
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
22.2%
2/9 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
10.2%
5/49 • Number of events 5 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
10.2%
5/49 • Number of events 5 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
4.3%
2/47 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/49 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
12.0%
6/50 • Number of events 6 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
|
Eye disorders
EYE PRURITUS
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/49 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/49 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
6.4%
3/47 • Number of events 3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/49 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
6.0%
3/50 • Number of events 3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
|
Eye disorders
EYELIDS PRURITUS
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/49 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/49 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
6.4%
3/47 • Number of events 3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/49 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/50 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
|
Eye disorders
FOREIGN BODY SENSATION IN EYES
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
2.0%
1/49 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/49 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/47 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/49 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
2.0%
1/50 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
|
Eye disorders
VISION BLURRED
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/49 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/49 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
4.3%
2/47 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/49 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
18.0%
9/50 • Number of events 9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
|
Gastrointestinal disorders
FOOD POISONING
|
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/49 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/49 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/47 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/49 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/50 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
|
Infections and infestations
COVID-19
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
2.0%
1/49 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
4.1%
2/49 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
2.1%
1/47 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
6.1%
3/49 • Number of events 3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/50 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/49 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
6.1%
3/49 • Number of events 3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/47 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
2.0%
1/49 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/50 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
|
Investigations
BLOOD PRESSURE DIASTOLIC INCREASED
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/49 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/49 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/47 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/49 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/50 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
|
Investigations
BLOOD PRESSURE INCREASED
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/49 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
2.0%
1/49 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/47 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/49 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
2.0%
1/50 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
|
Nervous system disorders
DYSGEUSIA
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/9 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/49 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/49 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
6.4%
3/47 • Number of events 3 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
0.00%
0/49 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
12.0%
6/50 • Number of events 6 • All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER