Phase 1/2 Study of AGN-241622 in Healthy Participants and Participants With Presbyopia

NCT ID: NCT04403763

Last Updated: 2024-02-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-27

Study Completion Date

2022-12-05

Brief Summary

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The objective of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AGN-241622 ophthalmic solution for the first time in human participants

Detailed Description

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Conditions

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Presbyopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo Dose

Administered as single drop in one or both eyes

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

Topical eye drop

Cohort 1: AGN-241622 Dose 1 (Low Dose)

Administered as single drop in one eye

Group Type EXPERIMENTAL

AGN-241622

Intervention Type DRUG

Topical eye drop

Cohort 2: AGN-241622 Dose 2 (Medium Dose)

Administered as single drop in one eye

Group Type EXPERIMENTAL

AGN-241622

Intervention Type DRUG

Topical eye drop

Cohort 3: AGN-241622 Dose 3 (High Dose)

Administered as single drop in one eye

Group Type EXPERIMENTAL

AGN-241622

Intervention Type DRUG

Topical eye drop

Cohort 4: AGN-241622 Dose 1 (Low Dose)

Administered as a single drop in each eye

Group Type EXPERIMENTAL

AGN-241622

Intervention Type DRUG

Topical eye drop

Cohort 5: AGN-241622 Dose 2 (Medium Dose)

Administered as single drop in each eye

Group Type EXPERIMENTAL

AGN-241622

Intervention Type DRUG

Topical eye drop

Cohort 6: AGN-241622 Dose 3 (High Dose)

Administered as single drop in each eye

Group Type EXPERIMENTAL

AGN-241622

Intervention Type DRUG

Topical eye drop

Interventions

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AGN-241622

Topical eye drop

Intervention Type DRUG

Vehicle

Topical eye drop

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 40 to 65 at the time of study participation.
* Be a nonsmoker and nonuser of nicotine-containing products within the previous 1 year.
* Be able and willing to follow study instructions and complete all required study visits in the opinion of the study doctor.

Exclusion Criteria

* History of alcohol or substance abuse within the 5 years prior to study participation.
* Enrollment in another investigational drug or device study within 30 days of study participation.
* Women who are pregnant, nursing, or planning a pregnancy during the study.
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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United Medical Research Institute /ID# 234612

Inglewood, California, United States

Site Status

Global Research Foundation /ID# 237353

Los Angeles, California, United States

Site Status

North Valley Eye Medical Group, Inc. /ID# 236686

Mission Hills, California, United States

Site Status

The Eye Research Foundation /ID# 234526

Newport Beach, California, United States

Site Status

Quantum Clinical Trials /ID# 237330

Miami Beach, Florida, United States

Site Status

Kannarr Eye Care /ID# 236718

Pittsburg, Kansas, United States

Site Status

The Eye Care Institute /ID# 234507

Louisville, Kentucky, United States

Site Status

Total Eye Care, PA /ID# 234454

Memphis, Tennessee, United States

Site Status

PPD Clinical Research Unit - Austin /ID# 237644

Austin, Texas, United States

Site Status

Eye associates /ID# 236502

San Antonio, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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http://www.AllerganClinicalTrials.com

Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact [email protected] for assistance

Other Identifiers

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2011-101-013

Identifier Type: -

Identifier Source: org_study_id

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