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A Safety, Efficacy and Pharmacokinetic Study of AGN-199201 and AGN-190584 in Patients With Presbyopia

A Phase 2, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety, Efficacy, and Pharmacokinetics of the Fixed Combination of AGN-199201 and AGN-190584 in Patients With Presbyopia

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02780115
Enrollment
151
Registered
2016-05-23
Start date
2016-05-26
Completion date
2017-10-31
Last updated
2020-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Presbyopia

Brief summary

This is a safety, efficacy and pharmacokinetics study of the fixed combination of AGN-199201 and AGN-190584 in participants with presbyopia (inability to focus on items close-up).

Interventions

DRUGAGN-199201 ophthalmic solution

1 drop of AGN-199201 ophthalmic solution Doses A, B, C in the eye.

DRUGAGN-190584 ophthalmic solution

1 drop of AGN-190584 ophthalmic solution Doses A, B, C in the eye.

DRUGAGN-199201 Vehicle

Vehicle to AGN-199201

DRUGAGN-190584 Vehicle

Vehicle to AGN-190584

Sponsors

Allergan
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
40 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

* Normal vision at distance, either natural or post corneal laser refractive surgery, with presbyopia in each eye and complaints of poor near vision that impacts activities of daily living

Exclusion criteria

* Use of any topical ophthalmic medications, including artificial tears other than the study medications during the study * Corneal abnormalities in either eye that interfere with visual acuity * History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery or any intraocular surgery * Diagnosis of glaucoma or ocular hypertension.

Design outcomes

Primary

MeasureTime frameDescription
Weighted Average Change From Baseline in Uncorrected Near Visual Acuity (UNVA) Letters in the Nondominant EyeBaseline, Day 28UNVA 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.

Secondary

MeasureTime frameDescription
Number of Participants Experiencing One or More Treatment Emergent Adverse Events (TEAEs)up to 65 daysA 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.

Countries

United States

Participant flow

Pre-assignment details

Randomization and treatment assignment were based on a randomization scheme prepared by Allergan Biostatistics prior to the start of the study.

Participants by arm

ArmCount
Cohort 1: Vehicle Control
Vehicle dosed in both eyes administered once daily during office visits 1 through 5.
28
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.
30
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.
30
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.
32
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.
31
Total151

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004
Overall StudyAdverse Event00011
Overall StudyWithdrawal by Subject01100

Baseline characteristics

CharacteristicCohort 1: Vehicle ControlCohort 2: AGN-199201 Lower Dose and AGN-190584 Lower DoseCohort 3: AGN-199201 Medium Dose and AGN-190584 Medium DoseCohort 4: AGN-199201 Higher Dose and AGN-190584 Higher DoseCohort 5: Vehicle, AGN-199201 Higher Dose and AGN-190584 Higher DoseTotal
Age, Continuous48.3 Years
STANDARD_DEVIATION 3.9
49.4 Years
STANDARD_DEVIATION 2.7
47.9 Years
STANDARD_DEVIATION 3.9
49.2 Years
STANDARD_DEVIATION 3.8
48.1 Years
STANDARD_DEVIATION 3.4
48.6 Years
STANDARD_DEVIATION 3.6
Baseline UNVA severity
≤ 20/80
20 Participants20 Participants18 Participants19 Participants22 Participants99 Participants
Baseline UNVA severity
> 20/80
8 Participants10 Participants12 Participants13 Participants9 Participants52 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
9 Participants10 Participants11 Participants9 Participants14 Participants53 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
19 Participants20 Participants19 Participants23 Participants17 Participants98 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants1 Participants0 Participants0 Participants0 Participants2 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants0 Participants0 Participants1 Participants2 Participants
Race (NIH/OMB)
Black or African American
3 Participants5 Participants5 Participants8 Participants4 Participants25 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants1 Participants0 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants0 Participants0 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
23 Participants23 Participants25 Participants23 Participants26 Participants120 Participants
Sex: Female, Male
Female
19 Participants20 Participants18 Participants25 Participants23 Participants105 Participants
Sex: Female, Male
Male
9 Participants10 Participants12 Participants7 Participants8 Participants46 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
deaths
Total, all-cause mortality
0 / 280 / 300 / 300 / 320 / 31
other
Total, other adverse events
7 / 288 / 3010 / 3011 / 327 / 31
serious
Total, serious adverse events
0 / 280 / 300 / 300 / 320 / 31

Outcome results

Primary

Weighted Average Change From Baseline in Uncorrected Near Visual Acuity (UNVA) Letters in the Nondominant Eye

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.

Time frame: Baseline, Day 28

Population: 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.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Cohort 1: Vehicle ControlWeighted Average Change From Baseline in Uncorrected Near Visual Acuity (UNVA) Letters in the Nondominant Eye3.00 letters correctly readStandard Error 1.03
Cohort 2: AGN-199201 Lower Dose and AGN-190584 Lower DoseWeighted Average Change From Baseline in Uncorrected Near Visual Acuity (UNVA) Letters in the Nondominant Eye4.96 letters correctly readStandard Error 1
Cohort 3: AGN-199201 Medium Dose and AGN-190584 Medium DoseWeighted Average Change From Baseline in Uncorrected Near Visual Acuity (UNVA) Letters in the Nondominant Eye7.77 letters correctly readStandard Error 1
Cohort 4: AGN-199201 Higher Dose and AGN-190584 Higher DoseWeighted Average Change From Baseline in Uncorrected Near Visual Acuity (UNVA) Letters in the Nondominant Eye7.54 letters correctly readStandard Error 0.97
Cohort 5: Vehicle, AGN-199201 Higher Dose and AGN-190584 Higher DoseWeighted Average Change From Baseline in Uncorrected Near Visual Acuity (UNVA) Letters in the Nondominant Eye7.81 letters correctly readStandard Error 1.02
p-value: 0.166395% CI: [-0.83, 4.74]ANCOVA
p-value: 0.000995% CI: [1.98, 7.56]ANCOVA
p-value: 0.001495% CI: [1.79, 7.29]ANCOVA
p-value: 0.000895% CI: [2.03, 7.58]ANCOVA
Secondary

Number of Participants Experiencing One or More Treatment Emergent Adverse Events (TEAEs)

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.

Time frame: up to 65 days

Population: 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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Cohort 1: Vehicle ControlNumber of Participants Experiencing One or More Treatment Emergent Adverse Events (TEAEs)8 Participants
Cohort 2: AGN-199201 Lower Dose and AGN-190584 Lower DoseNumber of Participants Experiencing One or More Treatment Emergent Adverse Events (TEAEs)12 Participants
Cohort 3: AGN-199201 Medium Dose and AGN-190584 Medium DoseNumber of Participants Experiencing One or More Treatment Emergent Adverse Events (TEAEs)15 Participants
Cohort 4: AGN-199201 Higher Dose and AGN-190584 Higher DoseNumber of Participants Experiencing One or More Treatment Emergent Adverse Events (TEAEs)15 Participants
Cohort 5: Vehicle, AGN-199201 Higher Dose and AGN-190584 Higher DoseNumber of Participants Experiencing One or More Treatment Emergent Adverse Events (TEAEs)10 Participants

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026