Adults 40 to 55, any sex, with Presbyopia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Weighted Average Change From Baseline in Uncorrected Near Visual Acuity (UNVA) Letters in the Nondominant EyePrimary· Baseline, Day 28
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.
Group
Value
95% CI
Cohort 1: Vehicle Control
3.00
± 1.03
Cohort 2: AGN-199201 Lower Dose and AGN-190584 Lower Dose
4.96
± 1.00
Cohort 3: AGN-199201 Medium Dose and AGN-190584 Medium Dose
7.77
± 1.00
Cohort 4: AGN-199201 Higher Dose and AGN-190584 Higher Dose
7.54
± 0.97
Cohort 5: Vehicle, AGN-199201 Higher Dose and AGN-190584 Higher Dose
7.81
± 1.02
Number of Participants Experiencing One or More Treatment Emergent Adverse Events (TEAEs)Secondary· up to 65 days
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.
Group
Value
95% CI
Cohort 1: Vehicle Control
8
Cohort 2: AGN-199201 Lower Dose and AGN-190584 Lower Dose
12
Cohort 3: AGN-199201 Medium Dose and AGN-190584 Medium Dose
15
Cohort 4: AGN-199201 Higher Dose and AGN-190584 Higher Dose
15
Cohort 5: Vehicle, AGN-199201 Higher Dose and AGN-190584 Higher Dose
10
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events were collected for up to 65 days..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Cohort 1: Vehicle Control
Serious: 0/28 (0%)
Deaths: 0/28
Cohort 2: AGN-199201 Lower Dose and AGN-190584 Lower Dose
Serious: 0/30 (0%)
Deaths: 0/30
Cohort 3: AGN-199201 Medium Dose and AGN-190584 Medium Dose
Serious: 0/30 (0%)
Deaths: 0/30
Cohort 4: AGN-199201 Higher Dose and AGN-190584 Higher Dose
Serious: 0/32 (0%)
Deaths: 0/32
Cohort 5: Vehicle, AGN-199201 Higher Dose and AGN-190584 Higher Dose
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).
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
NCT02595528 — A Study of the Concurrent Use of AGN-190584 and AGN-199201 in Participants With Presbyopia
· Phase 2
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Allergan
Last refreshed: 22 December 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02780115.