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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
Summary
This trial is testing eye drops to see if they are safe and effective for people aged 40-80 who have had cataract surgery and now struggle to focus on close objects. Participants will use the eye drops daily for a short period, and doctors will monitor their progress through regular check-ups and questionnaires.
Eligible Conditions
- Presbyopia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 14 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 14 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants Experiencing Adverse Events (AEs)
Side effects data
From 2021 Phase 3 trial • 43 Patients • NCT0483748233%
HEADACHE
29%
VISUAL IMPAIRMENT
29%
EYE PAIN
14%
VISION BLURRED
10%
PHOTOPHOBIA
10%
OCULAR HYPERAEMIA
10%
DRY EYE
5%
NAUSEA
100%
80%
60%
40%
20%
0%
Study treatment Arm
Period 2 (Vehicle to AGN-190584)
Period 2 (AGN-190584 to Vehicle)
Period 1 (AGN-190584)
Period 1 (Vehicle)
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
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Who is running the clinical trial?
AllerganLead Sponsor
781 Previous Clinical Trials
276,654 Total Patients Enrolled
8 Trials studying Presbyopia
1,482 Patients Enrolled for Presbyopia
ALLERGAN INC.Study DirectorAllergan
75 Previous Clinical Trials
79,544 Total Patients Enrolled
3 Trials studying Presbyopia
353 Patients Enrolled for Presbyopia
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