Trial Outcomes & Findings for A Safety, Efficacy and Pharmacokinetic Study of AGN-199201 and AGN-190584 in Patients With Presbyopia (NCT NCT02780115)
NCT ID: NCT02780115
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
151 participants
Primary outcome timeframe
Baseline, Day 28
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 |
Cohort 1: Vehicle Control
Vehicle dosed in both eyes administered once daily during office visits 1 through 5.
|
Cohort 2: AGN-199201 Lower Dose and AGN-190584 Lower Dose
Fixed combinations of AGN-199201 Lower Dose and AGN-190584 Lower Dose dosed in both eyes administered once daily during office visits 1 through 5.
|
Cohort 3: AGN-199201 Medium Dose and AGN-190584 Medium Dose
Fixed combinations of AGN-199201 Medium Dose and AGN-190584 Medium Dose dosed in both eyes administered once daily during office visits 1 through 5.
|
Cohort 4: AGN-199201 Higher Dose and AGN-190584 Higher Dose
Fixed combinations of AGN-199201 Higher Dose and AGN-190584 Higher Dose dosed in both eyes administered once daily during office visits 1 through 5.
|
Cohort 5: Vehicle, AGN-199201 Higher Dose and AGN-190584 Higher Dose
Dominant eye dosed with Vehicle. Fixed combinations of AGN-199201 Higher Dose and AGN-190584 Higher Dose dosed in nondominant eye. Treatment administered once daily during office visits 1 through 5.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
28
|
30
|
30
|
32
|
31
|
|
Overall Study
COMPLETED
|
28
|
29
|
29
|
31
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
Cohort 1: Vehicle Control
Vehicle dosed in both eyes administered once daily during office visits 1 through 5.
|
Cohort 2: AGN-199201 Lower Dose and AGN-190584 Lower Dose
Fixed combinations of AGN-199201 Lower Dose and AGN-190584 Lower Dose dosed in both eyes administered once daily during office visits 1 through 5.
|
Cohort 3: AGN-199201 Medium Dose and AGN-190584 Medium Dose
Fixed combinations of AGN-199201 Medium Dose and AGN-190584 Medium Dose dosed in both eyes administered once daily during office visits 1 through 5.
|
Cohort 4: AGN-199201 Higher Dose and AGN-190584 Higher Dose
Fixed combinations of AGN-199201 Higher Dose and AGN-190584 Higher Dose dosed in both eyes administered once daily during office visits 1 through 5.
|
Cohort 5: Vehicle, AGN-199201 Higher Dose and AGN-190584 Higher Dose
Dominant eye dosed with Vehicle. Fixed combinations of AGN-199201 Higher Dose and AGN-190584 Higher Dose dosed in nondominant eye. Treatment administered once daily during office visits 1 through 5.
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
A Safety, Efficacy and Pharmacokinetic Study of AGN-199201 and AGN-190584 in Patients With Presbyopia
Baseline characteristics by cohort
| Measure |
Cohort 1: Vehicle Control
n=28 Participants
Vehicle dosed in both eyes administered once daily during office visits 1 through 5.
|
Cohort 2: AGN-199201 Lower Dose and AGN-190584 Lower Dose
n=30 Participants
Fixed combinations of AGN-199201 Lower Dose and AGN-190584 Lower Dose dosed in both eyes administered once daily during office visits 1 through 5.
|
Cohort 3: AGN-199201 Medium Dose and AGN-190584 Medium Dose
n=30 Participants
Fixed combinations of AGN-199201 Medium Dose and AGN-190584 Medium Dose dosed in both eyes administered once daily during office visits 1 through 5.
|
Cohort 4: AGN-199201 Higher Dose and AGN-190584 Higher Dose
n=32 Participants
Fixed combinations of AGN-199201 Higher Dose and AGN-190584 Higher Dose dosed in both eyes administered once daily during office visits 1 through 5.
|
Cohort 5: Vehicle, AGN-199201 Higher Dose and AGN-190584 Higher Dose
n=31 Participants
Dominant eye dosed with Vehicle. Fixed combinations of AGN-199201 Higher Dose and AGN-190584 Higher Dose dosed in nondominant eye. Treatment administered once daily during office visits 1 through 5.
|
Total
n=151 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
48.3 Years
STANDARD_DEVIATION 3.9 • n=5 Participants
|
49.4 Years
STANDARD_DEVIATION 2.7 • n=7 Participants
|
47.9 Years
STANDARD_DEVIATION 3.9 • n=5 Participants
|
49.2 Years
STANDARD_DEVIATION 3.8 • n=4 Participants
|
48.1 Years
STANDARD_DEVIATION 3.4 • n=21 Participants
|
48.6 Years
STANDARD_DEVIATION 3.6 • n=10 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
105 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
46 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
53 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
98 Participants
n=10 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=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
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
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
25 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
120 Participants
n=10 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
|
1 Participants
n=10 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=10 Participants
|
|
Baseline UNVA severity
≤ 20/80
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
99 Participants
n=10 Participants
|
|
Baseline UNVA severity
> 20/80
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
52 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 28Population: 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 |
Cohort 1: Vehicle Control
n=28 Participants
Vehicle dosed in both eyes administered once daily during office visits 1 through 5.
|
Cohort 2: AGN-199201 Lower Dose and AGN-190584 Lower Dose
n=30 Participants
Fixed combinations of AGN-199201 Lower Dose and AGN-190584 Lower Dose dosed in both eyes administered once daily during office visits 1 through 5.
|
Cohort 3: AGN-199201 Medium Dose and AGN-190584 Medium Dose
n=30 Participants
Fixed combinations of AGN-199201 Medium Dose and AGN-190584 Medium Dose dosed in both eyes administered once daily during office visits 1 through 5.
|
Cohort 4: AGN-199201 Higher Dose and AGN-190584 Higher Dose
n=32 Participants
Fixed combinations of AGN-199201 Higher Dose and AGN-190584 Higher Dose dosed in both eyes administered once daily during office visits 1 through 5.
|
Cohort 5: Vehicle, AGN-199201 Higher Dose and AGN-190584 Higher Dose
n=31 Participants
Dominant eye dosed with Vehicle. Fixed combinations of AGN-199201 Higher Dose and AGN-190584 Higher Dose dosed in nondominant eye. Treatment administered once daily during office visits 1 through 5.
|
|---|---|---|---|---|---|
|
Weighted Average Change From Baseline in Uncorrected Near Visual Acuity (UNVA) Letters in the Nondominant Eye
|
3.00 letters correctly read
Standard Error 1.03
|
4.96 letters correctly read
Standard Error 1.00
|
7.77 letters correctly read
Standard Error 1.00
|
7.54 letters correctly read
Standard Error 0.97
|
7.81 letters correctly read
Standard Error 1.02
|
SECONDARY outcome
Timeframe: up to 65 daysPopulation: 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.
A Treatment Emergent Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Adverse Drug Reaction was a harmful and unintended reaction that is incurred during routine administration or use of the drug, whose causal relationship with the drug cannot be excluded.
Outcome measures
| Measure |
Cohort 1: Vehicle Control
n=28 Participants
Vehicle dosed in both eyes administered once daily during office visits 1 through 5.
|
Cohort 2: AGN-199201 Lower Dose and AGN-190584 Lower Dose
n=30 Participants
Fixed combinations of AGN-199201 Lower Dose and AGN-190584 Lower Dose dosed in both eyes administered once daily during office visits 1 through 5.
|
Cohort 3: AGN-199201 Medium Dose and AGN-190584 Medium Dose
n=30 Participants
Fixed combinations of AGN-199201 Medium Dose and AGN-190584 Medium Dose dosed in both eyes administered once daily during office visits 1 through 5.
|
Cohort 4: AGN-199201 Higher Dose and AGN-190584 Higher Dose
n=32 Participants
Fixed combinations of AGN-199201 Higher Dose and AGN-190584 Higher Dose dosed in both eyes administered once daily during office visits 1 through 5.
|
Cohort 5: Vehicle, AGN-199201 Higher Dose and AGN-190584 Higher Dose
n=31 Participants
Dominant eye dosed with Vehicle. Fixed combinations of AGN-199201 Higher Dose and AGN-190584 Higher Dose dosed in nondominant eye. Treatment administered once daily during office visits 1 through 5.
|
|---|---|---|---|---|---|
|
Number of Participants Experiencing One or More Treatment Emergent Adverse Events (TEAEs)
|
8 Participants
|
12 Participants
|
15 Participants
|
15 Participants
|
10 Participants
|
Adverse Events
Cohort 1: Vehicle Control
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 2: AGN-199201 Lower Dose and AGN-190584 Lower Dose
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort 3: AGN-199201 Medium Dose and AGN-190584 Medium Dose
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort 4: AGN-199201 Higher Dose and AGN-190584 Higher Dose
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Cohort 5: Vehicle, AGN-199201 Higher Dose and AGN-190584 Higher Dose
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1: Vehicle Control
n=28 participants at risk
Vehicle dosed in both eyes administered once daily during office visits 1 through 5.
|
Cohort 2: AGN-199201 Lower Dose and AGN-190584 Lower Dose
n=30 participants at risk
Fixed combinations of AGN-199201 Lower Dose and AGN-190584 Lower Dose dosed in both eyes administered once daily during office visits 1 through 5.
|
Cohort 3: AGN-199201 Medium Dose and AGN-190584 Medium Dose
n=30 participants at risk
Fixed combinations of AGN-199201 Medium Dose and AGN-190584 Medium Dose dosed in both eyes administered once daily during office visits 1 through 5.
|
Cohort 4: AGN-199201 Higher Dose and AGN-190584 Higher Dose
n=32 participants at risk
Fixed combinations of AGN-199201 Higher Dose and AGN-190584 Higher Dose dosed in both eyes administered once daily during office visits 1 through 5.
|
Cohort 5: Vehicle, AGN-199201 Higher Dose and AGN-190584 Higher Dose
n=31 participants at risk
Dominant eye dosed with Vehicle. Fixed combinations of AGN-199201 Higher Dose and AGN-190584 Higher Dose dosed in nondominant eye. Treatment administered once daily during office visits 1 through 5.
|
|---|---|---|---|---|---|
|
Eye disorders
Vision blurred
|
0.00%
0/28 • Adverse Events were collected for up to 65 days.
Safety population: All patients who received ≥ 1 administration of study treatment
|
6.7%
2/30 • Adverse Events were collected for up to 65 days.
Safety population: All patients who received ≥ 1 administration of study treatment
|
10.0%
3/30 • Adverse Events were collected for up to 65 days.
Safety population: All patients who received ≥ 1 administration of study treatment
|
9.4%
3/32 • Adverse Events were collected for up to 65 days.
Safety population: All patients who received ≥ 1 administration of study treatment
|
6.5%
2/31 • Adverse Events were collected for up to 65 days.
Safety population: All patients who received ≥ 1 administration of study treatment
|
|
General disorders
Instillation site pruritus
|
0.00%
0/28 • Adverse Events were collected for up to 65 days.
Safety population: All patients who received ≥ 1 administration of study treatment
|
13.3%
4/30 • Adverse Events were collected for up to 65 days.
Safety population: All patients who received ≥ 1 administration of study treatment
|
0.00%
0/30 • Adverse Events were collected for up to 65 days.
Safety population: All patients who received ≥ 1 administration of study treatment
|
3.1%
1/32 • Adverse Events were collected for up to 65 days.
Safety population: All patients who received ≥ 1 administration of study treatment
|
6.5%
2/31 • Adverse Events were collected for up to 65 days.
Safety population: All patients who received ≥ 1 administration of study treatment
|
|
General disorders
Instillation site foreign body sensation
|
10.7%
3/28 • Adverse Events were collected for up to 65 days.
Safety population: All patients who received ≥ 1 administration of study treatment
|
10.0%
3/30 • Adverse Events were collected for up to 65 days.
Safety population: All patients who received ≥ 1 administration of study treatment
|
3.3%
1/30 • Adverse Events were collected for up to 65 days.
Safety population: All patients who received ≥ 1 administration of study treatment
|
0.00%
0/32 • Adverse Events were collected for up to 65 days.
Safety population: All patients who received ≥ 1 administration of study treatment
|
3.2%
1/31 • Adverse Events were collected for up to 65 days.
Safety population: All patients who received ≥ 1 administration of study treatment
|
|
General disorders
Instillation site pain
|
10.7%
3/28 • Adverse Events were collected for up to 65 days.
Safety population: All patients who received ≥ 1 administration of study treatment
|
13.3%
4/30 • Adverse Events were collected for up to 65 days.
Safety population: All patients who received ≥ 1 administration of study treatment
|
3.3%
1/30 • Adverse Events were collected for up to 65 days.
Safety population: All patients who received ≥ 1 administration of study treatment
|
9.4%
3/32 • Adverse Events were collected for up to 65 days.
Safety population: All patients who received ≥ 1 administration of study treatment
|
3.2%
1/31 • Adverse Events were collected for up to 65 days.
Safety population: All patients who received ≥ 1 administration of study treatment
|
|
General disorders
Instillation site lacrimation
|
10.7%
3/28 • Adverse Events were collected for up to 65 days.
Safety population: All patients who received ≥ 1 administration of study treatment
|
10.0%
3/30 • Adverse Events were collected for up to 65 days.
Safety population: All patients who received ≥ 1 administration of study treatment
|
6.7%
2/30 • Adverse Events were collected for up to 65 days.
Safety population: All patients who received ≥ 1 administration of study treatment
|
3.1%
1/32 • Adverse Events were collected for up to 65 days.
Safety population: All patients who received ≥ 1 administration of study treatment
|
0.00%
0/31 • Adverse Events were collected for up to 65 days.
Safety population: All patients who received ≥ 1 administration of study treatment
|
|
Infections and infestations
Upper respiratory tract infection
|
3.6%
1/28 • Adverse Events were collected for up to 65 days.
Safety population: All patients who received ≥ 1 administration of study treatment
|
0.00%
0/30 • Adverse Events were collected for up to 65 days.
Safety population: All patients who received ≥ 1 administration of study treatment
|
16.7%
5/30 • Adverse Events were collected for up to 65 days.
Safety population: All patients who received ≥ 1 administration of study treatment
|
3.1%
1/32 • Adverse Events were collected for up to 65 days.
Safety population: All patients who received ≥ 1 administration of study treatment
|
3.2%
1/31 • Adverse Events were collected for up to 65 days.
Safety population: All patients who received ≥ 1 administration of study treatment
|
|
Nervous system disorders
Headache
|
10.7%
3/28 • Adverse Events were collected for up to 65 days.
Safety population: All patients who received ≥ 1 administration of study treatment
|
16.7%
5/30 • Adverse Events were collected for up to 65 days.
Safety population: All patients who received ≥ 1 administration of study treatment
|
20.0%
6/30 • Adverse Events were collected for up to 65 days.
Safety population: All patients who received ≥ 1 administration of study treatment
|
31.2%
10/32 • Adverse Events were collected for up to 65 days.
Safety population: All patients who received ≥ 1 administration of study treatment
|
19.4%
6/31 • Adverse Events were collected for up to 65 days.
Safety population: All patients 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