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A Study of the Concurrent Use of AGN-190584 and AGN-199201 in Participants With Presbyopia

NCT ID: NCT02595528

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

163 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-29

Study Completion Date

2017-10-18

Brief Summary

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This study will identify the optimum concentrations of AGN-199201 and AGN-190584 when dosed in combination once a day for the improvement of uncorrected near visual acuity 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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AGN-199201 and AGN-190584 Vehicle

Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Dose A followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Dose B followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Dose C followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.

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 AGN-190584 ophthalmic solution doses A, B and C in the eye.

AGN-190584 vehicle

Intervention Type DRUG

Vehicle to AGN-190584

AGN-199201 + AGN-190584 Combination

Intervention Type DRUG

1 drop AGN-199201 and AGN-190584 fixed combination ophthalmic solution in the eye.

AGN-199201 vehicle

Intervention Type DRUG

Vehicle to AGN-199201

AGN-199201 and AGN-190584 Dose A

Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Dose A, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Dose A followed by 1 drop AGN-190584 Dose A, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Dose B followed by 1 drop AGN-190584 Dose A, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Dose C followed by 1 drop AGN-190584 Dose A, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.

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 AGN-190584 ophthalmic solution doses A, B and C in the eye.

AGN-190584 vehicle

Intervention Type DRUG

Vehicle to AGN-190584

AGN-199201 + AGN-190584 Combination

Intervention Type DRUG

1 drop AGN-199201 and AGN-190584 fixed combination ophthalmic solution in the eye.

AGN-199201 vehicle

Intervention Type DRUG

Vehicle to AGN-199201

AGN-199201 and AGN-190584 Dose B

Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Dose B, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Dose A followed by 1 drop AGN-190584 Dose B, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Dose B followed by 1 drop AGN-190584 Dose B, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Dose C followed by 1 drop AGN-190584 Dose B, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.

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 AGN-190584 ophthalmic solution doses A, B and C in the eye.

AGN-190584 vehicle

Intervention Type DRUG

Vehicle to AGN-190584

AGN-199201 + AGN-190584 Combination

Intervention Type DRUG

1 drop AGN-199201 and AGN-190584 fixed combination ophthalmic solution in the eye.

AGN-199201 vehicle

Intervention Type DRUG

Vehicle to AGN-199201

AGN-199201 and AGN-190584 Dose C

Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Dose C, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Dose A followed by 1 drop AGN-190584 Dose C, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Dose B followed by 1 drop AGN-190584 Dose C, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Dose C followed by 1 drop AGN-190584 Dose C, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.

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 AGN-190584 ophthalmic solution doses A, B and C in the eye.

AGN-190584 vehicle

Intervention Type DRUG

Vehicle to AGN-190584

AGN-199201 + AGN-190584 Combination

Intervention Type DRUG

1 drop AGN-199201 and AGN-190584 fixed combination ophthalmic solution in the eye.

AGN-199201 vehicle

Intervention Type DRUG

Vehicle to AGN-199201

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 AGN-190584 ophthalmic solution doses A, B and C in the eye.

Intervention Type DRUG

AGN-190584 vehicle

Vehicle to AGN-190584

Intervention Type DRUG

AGN-199201 + AGN-190584 Combination

1 drop AGN-199201 and AGN-190584 fixed combination ophthalmic solution in the eye.

Intervention Type DRUG

AGN-199201 vehicle

Vehicle to AGN-199201

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

50 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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Sall Research Medical Center

Artesia, California, United States

Site Status

Milton M. Hom, OD, FAAO

Azusa, California, United States

Site Status

WCCT Global, LLC

Costa Mesa, California, United States

Site Status

The Eye Research Foundation

Newport Beach, California, United States

Site Status

North Bay Eye Associates, Inc.

Petaluma, California, United States

Site Status

Martel Eye Medical Group

Rancho Cordova, California, United States

Site Status

West Coast Eye Care

San Diego, California, United States

Site Status

Corneal Consultants of Colorado, P.C.

Littleton, Colorado, United States

Site Status

Mid Florida Eye Center

Mt. Dora, Florida, United States

Site Status

Clayton Eye Center

Morrow, Georgia, United States

Site Status

Price Vision Group

Indianapolis, Indiana, United States

Site Status

Specialized Eye Care

Baltimore, Maryland, United States

Site Status

Comprehensive Eye Care, Ltd

Washington, Missouri, United States

Site Status

Cleveland Eye Clinic

Brecksville, Ohio, United States

Site Status

Scott & Christie and Associates, PC

Cranberry Township, Pennsylvania, 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

Medical Center Ophthalmology Associates

San Antonio, Texas, United States

Site Status

Hoopes Durrie Rivera Research, LLC

Draper, Utah, United States

Site Status

The Eye Centers of Racine & Kenosha

Kenosha, Wisconsin, United States

Site Status

Countries

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United States

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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199201-009

Identifier Type: -

Identifier Source: org_study_id