AGN-241622 for Presbyopia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Presbyopia
AGN-241622 - Drug
Eligibility
18+
All Sexes
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Study Summary

This trial is testing a new eye drop to see if it is safe and effective in humans.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Presbyopia

Study Objectives

2 Primary · 31 Secondary · Reporting Duration: 14 Days

14 Days
Stage 2a Plasma Pharmacokinetics: Accumulation ratio of AGN-241622
Stage 2a Plasma Pharmacokinetics: Apparent total clearance of AGN-241622 from plasma (CL/F)
Plasma Exchange
Stage 2a Plasma Pharmacokinetics: Area under the plasma/tear concentration versus time curve from time 0 to the end of the dosing period (AUC0-tau) of AGN-241622
Stage 2a Plasma Pharmacokinetics: Maximum plasma concentrations (Cmax) of AGN-241622
Stage 2a Plasma Pharmacokinetics: Minimum plasma concentrations (Cmin) of AGN-241622
Stage 2a Plasma Pharmacokinetics: Terminal elimination half-life (T1/2) of AGN-241622
Stage 2a Plasma Pharmacokinetics: Terminal elimination rate constant (λz) of AGN-241622
Plasma
Stage 2a Plasma Pharmacokinetics: Volume of distribution during the terminal elimination phase (Vz/F) of AGN-241622
Stage 2a Tears Pharmacokinetics: Area under the concentration-time curve from time 0 to time t (AUC0-t) of AGN-241622
Stage 2a Tears Pharmacokinetics: Area under the plasma/tear concentration versus time curve from time 0 to the end of the dosing period (AUC0-tau) of AGN-241622
Stage 2a Tears Pharmacokinetics: Maximum plasma concentrations (Cmax) of AGN-241622
Stage 2a Tears Pharmacokinetics: Terminal elimination half-life (T1/2) of AGN-241622
Stage 2a Tears Pharmacokinetics: Terminal elimination rate constant (λz) of AGN-241622
Stage 2a Tears Pharmacokinetics: Time of maximum plasma concentrations (Tmax) of AGN-241622
Stage 2a: Number of patients experiencing a treatment emergent adverse event after repeat administration of AGN-241622
Day 1
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
Stage 1 Plasma Pharmacokinetics: Maximum plasma concentrations (Cmax) of AGN-241622
Stage 1 Plasma Pharmacokinetics: Terminal elimination half-life (T1/2) of AGN-241622
Stage 1 Plasma Pharmacokinetics: Terminal elimination rate constant (λz) of AGN-241622
Stage 1 Plasma Pharmacokinetics: Time of maximum plasma concentrations (Tmax) of AGN-241622
Stage 1 Plasma Pharmacokinetics: Volume of distribution during the terminal elimination phase (Vz/F) of AGN-241622
Stage 1 Tears Pharmacokinetics: Area under the concentration-time curve from time 0 to infinity (AUC0-inf) of AGN-241622
Stage 1 Tears Pharmacokinetics: Area under the concentration-time curve from time 0 to time t (AUC0-t) of AGN-241622
Stage 1 Tears Pharmacokinetics: Maximum plasma concentrations (Cmax) of AGN-241622
Stage 1 Tears Pharmacokinetics: Terminal elimination half-life (T1/2) of AGN-241622
Stage 1 Tears Pharmacokinetics: Terminal elimination rate constant (λz) of AGN-241622
Stage 1 Tears Pharmacokinetics: Time of maximum plasma concentrations (Tmax) of AGN-241622
Stage 1: Pupil diameter measurement
Up to 2 days
Stage 1: Number of patients experiencing a treatment emergent adverse event after single administration of AGN-241622

Trial Safety

Safety Progress

1 of 3

Other trials for Presbyopia

Trial Design

5 Treatment Groups

AGN-190584
1 of 5
AGN-241622 Dose 2
1 of 5
AGN-241622 Dose 1
1 of 5
AGN-241622 Dose 3
1 of 5
Placebo Dose
1 of 5
Active Control
Experimental Treatment
Non-Treatment Group

144 Total Participants · 5 Treatment Groups

Primary Treatment: AGN-241622 · Has Placebo Group · Phase 1 & 2

AGN-241622 Dose 2
Drug
Experimental Group · 1 Intervention: AGN-241622 · Intervention Types: Drug
AGN-241622 Dose 1
Drug
Experimental Group · 1 Intervention: AGN-241622 · Intervention Types: Drug
AGN-241622 Dose 3
Drug
Experimental Group · 1 Intervention: AGN-241622 · Intervention Types: Drug
Placebo Dose
Drug
PlaceboComparator Group · 1 Intervention: Vehicle · Intervention Types: Drug
AGN-190584
Drug
ActiveComparator Group · 1 Intervention: AGN-190584 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 14 days

Who is running the clinical trial?

AllerganLead Sponsor
780 Previous Clinical Trials
275,956 Total Patients Enrolled
8 Trials studying Presbyopia
1,402 Patients Enrolled for Presbyopia
AbbVieLead Sponsor
822 Previous Clinical Trials
469,461 Total Patients Enrolled
Wayne Chen, PharmDStudy DirectorAllergan
Michelle ChenStudy DirectorAllergan
ABBVIE INC.Study DirectorAbbVie
295 Previous Clinical Trials
117,005 Total Patients Enrolled
ALLERGAN INC.Study DirectorAllergan
73 Previous Clinical Trials
78,241 Total Patients Enrolled
3 Trials studying Presbyopia
273 Patients Enrolled for Presbyopia

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
The study participants were between the ages of 40 and 65.
Do not smoke cigarettes or use any other nicotine-containing products for the past year.
I'm able and willing to follow study instructions and complete all required study visits in the opinion of the study doctor.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 28th, 2021

Last Reviewed: October 30th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.