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AGN-190584 for Presbyopia (ARIES Trial)

Phase 2
Waitlist Available
Research Sponsored by Allergan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 14 days
Awards & highlights

ARIES Trial Summary

Presbyopia is a condition in which the eye exhibits a diminished ability to focus on near objects with increasing age. This study will assess the safety and exploratory efficacy of AGN-190584 is in treating participants with pseudophakic presbyopia. AGN-190584 is approved (in the United States) for use in adults with presbyopia (including those who are pseudophakic) and this study is being conducted to better understand the safety and efficacy in the pseudophakic presbyopia population. This study is double-masked meaning that neither the participants nor the study doctors will know who will be given AGN-190584 and who will be given vehicle (does not contain treatment drug). Study doctors put the participants in 1 of the 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to vehicle. Approximately 150 participants aged 40-80 years with pseudophakic presbyopia will be enrolled in approximately 30 sites in the US. Participants will receive eye drops of AGN-190584 or vehicle once daily in the morning in each eye for 14 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study. The effect of the treatment will be evaluated by medical assessments, checking for side effects and completing questionnaires.

ARIES Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 14 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 14 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Experiencing Adverse Events (AEs)

Side effects data

From 2014 Phase 2 trial • 65 Patients • NCT02197806
27%
Eyelid Retraction
7%
Upper Respiratory Tract Infection
7%
Punctate Keratitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
AGN-199201
AGN-190584
AGN-199201 + AGN-190584 in One Eye
AGN-199201 + AGN-190584 in Both Eyes

ARIES Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AGN-190584Experimental Treatment1 Intervention
Participants will receive one drop of AGN-190584 instilled in each eye once daily for 14 days.
Group II: VehiclePlacebo Group1 Intervention
Participants will receive one drop of vehicle instilled in each eye once daily for 14 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AGN-190584
2021
Completed Phase 3
~110

Find a Location

Who is running the clinical trial?

AllerganLead Sponsor
781 Previous Clinical Trials
276,569 Total Patients Enrolled
8 Trials studying Presbyopia
1,482 Patients Enrolled for Presbyopia
ALLERGAN INC.Study DirectorAllergan
75 Previous Clinical Trials
79,259 Total Patients Enrolled
3 Trials studying Presbyopia
353 Patients Enrolled for Presbyopia

Frequently Asked Questions

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~0 spots leftby Apr 2025