Trial Outcomes & Findings for A Study of the Concurrent Use of AGN-190584 and AGN-199201 in Participants With Presbyopia (NCT NCT02595528)
NCT ID: NCT02595528
Last Updated: 2020-12-22
Results Overview
UNVA is assessed without corrective lenses in the non-dominant eye. UNVA is measured using an eye chart and is reported as the number of lines read correctly. The lower the number of lines read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of lines read correctly means that vision has improved.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
163 participants
Primary outcome timeframe
Baseline, Between hour 1 and hour 10 of each of the five 2-day dosing periods
Results posted on
2020-12-22
Participant Flow
Randomization and treatment assignment were based on a randomization scheme prepared by Allergan Biostatistics prior to the start of the study.
Participant milestones
| Measure |
AGN-190584 Vehicle and AGN-199201
Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.
|
AGN-190584 Lower Dose and AGN-199201
Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.
|
AGN-190584 Medium Dose and AGN-199201
Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.
|
AGN-190584 Higher Dose and AGN-199201
Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
41
|
40
|
42
|
40
|
|
Overall Study
COMPLETED
|
39
|
37
|
41
|
36
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
1
|
4
|
Reasons for withdrawal
| Measure |
AGN-190584 Vehicle and AGN-199201
Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.
|
AGN-190584 Lower Dose and AGN-199201
Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.
|
AGN-190584 Medium Dose and AGN-199201
Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.
|
AGN-190584 Higher Dose and AGN-199201
Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
1
|
Baseline Characteristics
A Study of the Concurrent Use of AGN-190584 and AGN-199201 in Participants With Presbyopia
Baseline characteristics by cohort
| Measure |
AGN-190584 Vehicle and AGN-199201
n=41 Participants
Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.
|
AGN-190584 Lower Dose and AGN-199201
n=39 Participants
Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.
|
AGN-190584 Medium Dose and AGN-199201
n=42 Participants
Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.
|
AGN-190584 Higher Dose and AGN-199201
n=39 Participants
Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.
|
Total
n=161 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
46.6 Years
STANDARD_DEVIATION 2.9 • n=5 Participants
|
47.1 Years
STANDARD_DEVIATION 2.7 • n=7 Participants
|
46.8 Years
STANDARD_DEVIATION 2.8 • n=5 Participants
|
46.7 Years
STANDARD_DEVIATION 2.3 • n=4 Participants
|
46.8 Years
STANDARD_DEVIATION 2.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
112 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
131 Participants
n=21 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 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
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
126 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 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
|
|
Baseline UNVA severity
≤ 20/80
|
26 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
108 Participants
n=21 Participants
|
|
Baseline UNVA severity
> 20/80
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, Between hour 1 and hour 10 of each of the five 2-day dosing periodsPopulation: Modified Intent-to-Treat (mITT) population: all randomized patients who were randomized with a baseline and at least 1 post baseline assessment of mesopic, high contrast, UNVA.
UNVA is assessed without corrective lenses in the non-dominant eye. UNVA is measured using an eye chart and is reported as the number of lines read correctly. The lower the number of lines read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of lines read correctly means that vision has improved.
Outcome measures
| Measure |
AGN-190584 Vehicle
n=40 Participants
Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.
|
AGN-190584 Lower Dose
n=37 Participants
Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.
|
AGN-190584 Medium Dose
n=42 Participants
Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.
|
AGN-190584 Higher Dose
n=38 Participants
Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.
|
|---|---|---|---|---|
|
Weighted Average Change From Baseline in Mesopic, High Contrast Uncorrected Near Visual Acuity (UNVA) Letters
AGN-199201 Medium Dose
|
1.47 letters correctly read
Standard Error 0.47
|
4.16 letters correctly read
Standard Error 0.39
|
5.56 letters correctly read
Standard Error 0.39
|
5.70 letters correctly read
Standard Error 0.48
|
|
Weighted Average Change From Baseline in Mesopic, High Contrast Uncorrected Near Visual Acuity (UNVA) Letters
AGN-199201 Higher Dose
|
1.34 letters correctly read
Standard Error 0.55
|
3.99 letters correctly read
Standard Error 0.41
|
5.36 letters correctly read
Standard Error 0.40
|
5.46 letters correctly read
Standard Error 0.56
|
|
Weighted Average Change From Baseline in Mesopic, High Contrast Uncorrected Near Visual Acuity (UNVA) Letters
AGN-199201 Vehicle
|
1.12 letters correctly read
Standard Error 0.48
|
3.83 letters correctly read
Standard Error 0.37
|
5.26 letters correctly read
Standard Error 0.37
|
5.42 letters correctly read
Standard Error 0.50
|
|
Weighted Average Change From Baseline in Mesopic, High Contrast Uncorrected Near Visual Acuity (UNVA) Letters
AGN-199201 Lower Dose
|
1.24 letters correctly read
Standard Error 0.44
|
3.94 letters correctly read
Standard Error 0.34
|
5.37 letters correctly read
Standard Error 0.34
|
5.52 letters correctly read
Standard Error 0.46
|
Adverse Events
AGN-190584 Vehicle and AGN-199201
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
AGN-190584 Lower Dose and AGN-199201
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
AGN-190584 Medium Dose and AGN-199201
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
AGN-190584 Higher Dose and AGN-199201
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AGN-190584 Vehicle and AGN-199201
n=41 participants at risk
Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.
|
AGN-190584 Lower Dose and AGN-199201
n=39 participants at risk
Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.
|
AGN-190584 Medium Dose and AGN-199201
n=42 participants at risk
Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.
|
AGN-190584 Higher Dose and AGN-199201
n=39 participants at risk
Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.
|
|---|---|---|---|---|
|
Investigations
Cervix carcinoma stage 0
|
2.4%
1/41 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
0.00%
0/39 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
0.00%
0/42 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
0.00%
0/39 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/41 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
2.6%
1/39 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
0.00%
0/42 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
0.00%
0/39 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Malignant melanoma
|
0.00%
0/41 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
0.00%
0/39 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
0.00%
0/42 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
2.6%
1/39 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
Other adverse events
| Measure |
AGN-190584 Vehicle and AGN-199201
n=41 participants at risk
Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.
|
AGN-190584 Lower Dose and AGN-199201
n=39 participants at risk
Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.
|
AGN-190584 Medium Dose and AGN-199201
n=42 participants at risk
Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.
|
AGN-190584 Higher Dose and AGN-199201
n=39 participants at risk
Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.
|
|---|---|---|---|---|
|
General disorders
Instillation site pain
|
7.3%
3/41 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
0.00%
0/39 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
2.4%
1/42 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
7.7%
3/39 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
|
Nervous system disorders
Headache
|
12.2%
5/41 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
10.3%
4/39 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
19.0%
8/42 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
17.9%
7/39 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/41 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
7.7%
3/39 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
4.8%
2/42 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
0.00%
0/39 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
|
Eye disorders
Foreign body sensation in eyes
|
2.4%
1/41 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
5.1%
2/39 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
0.00%
0/42 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
0.00%
0/39 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
|
Eye disorders
Punctate keratitis
|
4.9%
2/41 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
2.6%
1/39 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
9.5%
4/42 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
5.1%
2/39 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/41 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
5.1%
2/39 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
7.1%
3/42 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
2.6%
1/39 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
|
Eye disorders
Visual impairment
|
2.4%
1/41 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
0.00%
0/39 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
2.4%
1/42 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
10.3%
4/39 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/41 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
0.00%
0/39 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
2.4%
1/42 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
5.1%
2/39 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/41 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
0.00%
0/39 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
0.00%
0/42 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
5.1%
2/39 • Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER