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A Safety, Efficacy and Pharmacokinetic Study of AGN-199201 and AGN-190584 in Patients With Presbyopia

NCT ID: NCT02780115

Last Updated: 2020-12-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-26

Study Completion Date

2017-10-31

Brief Summary

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This is a safety, efficacy and pharmacokinetics study of the fixed combination of AGN-199201 and AGN-190584 in participants with presbyopia (inability to focus on items close-up).

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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Cohort 1: Vehicle Control

Vehicle dosed in both eyes administered once daily during office visits 1 through 5.

Group Type EXPERIMENTAL

AGN-199201 Vehicle

Intervention Type DRUG

Vehicle to AGN-199201

AGN-190584 Vehicle

Intervention Type DRUG

Vehicle to AGN-190584

Cohort 2: AGN-199201 Dose A and AGN-190584 Dose A

Fixed combinations of AGN-199201 Dose A and AGN-190584 Dose A dosed in both eyes administered once daily during office visits 1 through 5.

Group Type EXPERIMENTAL

AGN-199201 ophthalmic solution

Intervention Type DRUG

1 drop of AGN-199201 ophthalmic solution Doses A, B, C in the eye.

AGN-190584 ophthalmic solution

Intervention Type DRUG

1 drop of AGN-190584 ophthalmic solution Doses A, B, C in the eye.

Cohort 3: AGN-199201 Dose B and AGN-190584 Dose B

Fixed combinations of AGN-199201 Dose B and AGN-190584 Dose B dosed in both eyes administered once daily during office visits 1 through 5.

Group Type EXPERIMENTAL

AGN-199201 ophthalmic solution

Intervention Type DRUG

1 drop of AGN-199201 ophthalmic solution Doses A, B, C in the eye.

AGN-190584 ophthalmic solution

Intervention Type DRUG

1 drop of AGN-190584 ophthalmic solution Doses A, B, C in the eye.

Cohort 4: AGN-199201 Dose C and AGN-190584 Dose C

Fixed combinations of AGN-199201 Dose C and AGN-190584 Dose C dosed in both eyes administered once daily during office visits 1 through 5.

Group Type EXPERIMENTAL

AGN-199201 ophthalmic solution

Intervention Type DRUG

1 drop of AGN-199201 ophthalmic solution Doses A, B, C in the eye.

AGN-190584 ophthalmic solution

Intervention Type DRUG

1 drop of AGN-190584 ophthalmic solution Doses A, B, C in the eye.

Cohort 5: Vehicle, AGN-199201 Dose C and AGN-190584 Dose C

Dominant eye dosed with Vehicle. Fixed combinations of AGN-199201 Dose C and AGN-190584 Dose C dosed in nondominant eye. Treatment administered once daily during office visits 1 through 5.

Group Type EXPERIMENTAL

AGN-199201 ophthalmic solution

Intervention Type DRUG

1 drop of AGN-199201 ophthalmic solution Doses A, B, C in the eye.

AGN-190584 ophthalmic solution

Intervention Type DRUG

1 drop of AGN-190584 ophthalmic solution Doses A, B, C in the eye.

AGN-199201 Vehicle

Intervention Type DRUG

Vehicle to AGN-199201

AGN-190584 Vehicle

Intervention Type DRUG

Vehicle to AGN-190584

Interventions

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AGN-199201 ophthalmic solution

1 drop of AGN-199201 ophthalmic solution Doses A, B, C in the eye.

Intervention Type DRUG

AGN-190584 ophthalmic solution

1 drop of AGN-190584 ophthalmic solution Doses A, B, C in the eye.

Intervention Type DRUG

AGN-199201 Vehicle

Vehicle to AGN-199201

Intervention Type DRUG

AGN-190584 Vehicle

Vehicle to AGN-190584

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Normal vision at distance, either natural or post corneal laser refractive surgery, with presbyopia in each eye and complaints of poor near vision that impacts activities of daily living

Exclusion Criteria

* Use of any topical ophthalmic medications, including artificial tears other than the study medications during the study
* Corneal abnormalities in either eye that interfere with visual acuity
* History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery or any intraocular surgery
* Diagnosis of glaucoma or ocular hypertension.
Minimum Eligible Age

40 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Haixia Liu

Role: STUDY_DIRECTOR

Allergan

Locations

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Retina Institute of California Medical Group

Arcadia, California, United States

Site Status

Sall Research Medical Center

Artesia, California, United States

Site Status

WCCT Global, LLC

Cypress, California, United States

Site Status

Specialty Eye Care Medical Center

Glendale, California, United States

Site Status

Lugene Eye Institute

Glendale, California, United States

Site Status

The Eye Research Foundation

Newport Beach, California, United States

Site Status

Stanford Eye and Laser Center

Palo Alto, California, United States

Site Status

Wolstan and Golberg Eye Associates

Torrance, California, United States

Site Status

MedEye Associates

Miami, Florida, United States

Site Status

Central Florida Eye Institute

Ocala, Florida, United States

Site Status

Center for Sight

Sarasota, Florida, United States

Site Status

Clayton Eye Center

Morrow, Georgia, United States

Site Status

Silverstein Eye Centers

Louisville, Kentucky, United States

Site Status

The Eye Care Institute

Louisville, Kentucky, United States

Site Status

Specialized Eye Care

Baltimore, Maryland, United States

Site Status

James D. Branch

Winston-Salem, North Carolina, United States

Site Status

Devers Eye Institute

Portland, Oregon, United States

Site Status

Scott & Christie and Associates, PC

Cranberry Township, Pennsylvania, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Total Eye Care, PA

Memphis, Tennessee, United States

Site Status

Cataract and Glaucoma Center

El Paso, Texas, United States

Site Status

University of Texas Medical Branch

Galveston, Texas, United States

Site Status

R and R Eye Research, LLC

San Antonio, Texas, United States

Site Status

Medical Center Ophthalmology Associates

San Antonio, Texas, United States

Site Status

Hoopes Durrie Rivera Research, LLC

Draper, Utah, United States

Site Status

Countries

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United States

References

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Shirneshan E, Coon CD, Johnson N, Stokes J, Wells T, Lundy JJ, Andrae DA, Evans CJ, Campbell J. Development of the Near Vision Presbyopia Task-based Questionnaire for use in evaluating the impact of presbyopia. J Patient Rep Outcomes. 2021 Dec 2;5(1):125. doi: 10.1186/s41687-021-00378-y.

Reference Type DERIVED
PMID: 34855038 (View on PubMed)

Johnson N, Shirneshan E, Coon CD, Stokes J, Wells T, Lundy JJ, Andrae DA, Evans CJ, Campbell J. Development of the Presbyopia Impact and Coping Questionnaire. Ophthalmol Ther. 2021 Dec;10(4):1057-1075. doi: 10.1007/s40123-021-00391-w. Epub 2021 Oct 13.

Reference Type DERIVED
PMID: 34643894 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

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199201-010

Identifier Type: -

Identifier Source: org_study_id