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Summary
This trial is testing AGN-241622 eye drops to see if they are safe and effective. The study will check if the drops help with eye conditions without causing side effects.
Eligible Conditions
- Presbyopia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Stage 1: Number of Participants Experiencing a Treatment Emergent Adverse Event After Single Administration of AGN-241622
Stage 2a: Number of Patients Experiencing a Treatment Emergent Adverse Event After Repeat Administration of AGN-241622
Secondary study objectives
Stage 1 Plasma Pharmacokinetics: Apparent Total Clearance of AGN-241622 From Plasma (CL/F)
Stage 1 Plasma Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of AGN-241622
Stage 1 Plasma Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Time t (AUC0-t) of AGN-241622
+28 moreTrial Design
7Treatment groups
Experimental Treatment
Placebo Group
Group I: Cohort 6: AGN-241622 Dose 3 (High Dose)Experimental Treatment1 Intervention
Administered as single drop in each eye
Group II: Cohort 5: AGN-241622 Dose 2 (Medium Dose)Experimental Treatment1 Intervention
Administered as single drop in each eye
Group III: Cohort 4: AGN-241622 Dose 1 (Low Dose)Experimental Treatment1 Intervention
Administered as a single drop in each eye
Group IV: Cohort 3: AGN-241622 Dose 3 (High Dose)Experimental Treatment1 Intervention
Administered as single drop in one eye
Group V: Cohort 2: AGN-241622 Dose 2 (Medium Dose)Experimental Treatment1 Intervention
Administered as single drop in one eye
Group VI: Cohort 1: AGN-241622 Dose 1 (Low Dose)Experimental Treatment1 Intervention
Administered as single drop in one eye
Group VII: Placebo DosePlacebo Group1 Intervention
Administered as single drop in one or both eyes
Find a Location
Who is running the clinical trial?
AllerganLead Sponsor
781 Previous Clinical Trials
276,574 Total Patients Enrolled
8 Trials studying Presbyopia
1,402 Patients Enrolled for Presbyopia
AbbVieLead Sponsor
1,023 Previous Clinical Trials
520,209 Total Patients Enrolled
2 Trials studying Presbyopia
43 Patients Enrolled for Presbyopia
Wayne Chen, PharmDStudy DirectorAllergan
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