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

Back to results

Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

AGN-199201 ophthalmic solution

AGN-190584 ophthalmic solution

AGN-190584 vehicle

AGN-199201 + AGN-190584 Combination

AGN-199201 vehicle

About this trial

This is an interventional treatment trial for Presbyopia

Eligibility Criteria

40 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

AGN-199201 and AGN-190584 Vehicle

AGN-199201 and AGN-190584 Dose A

AGN-199201 and AGN-190584 Dose B

AGN-199201 and AGN-190584 Dose C

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Weighted Average Change From Baseline in Mesopic, High Contrast Uncorrected Near Visual Acuity (UNVA) Letters

UNVA is assessed without corrective lenses in the non-dominant eye. UNVA is measured using an eye chart and is reported as the number of lines read correctly. The lower the number of lines read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of lines read correctly means that vision has improved.

Secondary Outcome Measures

Full Information

NCT ID

NCT02595528

First Posted

November 2, 2015

Last Updated

December 1, 2020

Sponsor

Allergan

1. Study Identification

Unique Protocol Identification Number

NCT02595528

Brief Title

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

Official Title

A Phase 2, Multicenter, Double-masked, Randomized, Vehicle-Controlled, Study of the Concurrent Use of AGN-190584 and AGN-199201 in Patients With Presbyopia

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

April 29, 2016 (Actual)

Primary Completion Date

October 18, 2017 (Actual)

Study Completion Date

October 18, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Allergan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief Summary

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Presbyopia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

163 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AGN-199201 and AGN-190584 Vehicle

Arm Type

Experimental

Arm Description

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.

Arm Title

AGN-199201 and AGN-190584 Dose A

Arm Type

Experimental

Arm Description

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.

Arm Title

AGN-199201 and AGN-190584 Dose B

Arm Type

Experimental

Arm Description

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.

Arm Title

AGN-199201 and AGN-190584 Dose C

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

AGN-199201 ophthalmic solution

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

AGN-190584 ophthalmic solution

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

AGN-190584 vehicle

Intervention Description

Vehicle to AGN-190584

Intervention Type

Drug

Intervention Name(s)

AGN-199201 + AGN-190584 Combination

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

AGN-199201 vehicle

Intervention Description

Vehicle to AGN-199201

Primary Outcome Measure Information:

Title

Weighted Average Change From Baseline in Mesopic, High Contrast Uncorrected Near Visual Acuity (UNVA) Letters

Description

UNVA is assessed without corrective lenses in the non-dominant eye. UNVA is measured using an eye chart and is reported as the number of lines read correctly. The lower the number of lines read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of lines read correctly means that vision has improved.

Time Frame

Baseline, Between hour 1 and hour 10 of each of the five 2-day dosing periods

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Haixia Liu

Organizational Affiliation

Allergan

Official's Role

Study Director

Facility Information:

Facility Name

Sall Research Medical Center

City

Artesia

State/Province

California

ZIP/Postal Code

90701

Country

United States

Facility Name

Milton M. Hom, OD, FAAO

City

Azusa

State/Province

California

ZIP/Postal Code

91702

Country

United States

Facility Name

WCCT Global, LLC

City

Costa Mesa

State/Province

California

ZIP/Postal Code

92626

Country

United States

Facility Name

The Eye Research Foundation

City

Newport Beach

State/Province

California

ZIP/Postal Code

92663

Country

United States

Facility Name

North Bay Eye Associates, Inc.

City

Petaluma

State/Province

California

ZIP/Postal Code

94954

Country

United States

Facility Name

Martel Eye Medical Group

City

Rancho Cordova

State/Province

California

ZIP/Postal Code

95670

Country

United States

Facility Name

West Coast Eye Care

City

San Diego

State/Province

California

ZIP/Postal Code

92115

Country

United States

Facility Name

Corneal Consultants of Colorado, P.C.

City

Littleton

State/Province

Colorado

ZIP/Postal Code

80120

Country

United States

Facility Name

Mid Florida Eye Center

City

Mount Dora

State/Province

Florida

ZIP/Postal Code

32757

Country

United States

Facility Name

Clayton Eye Center

City

Morrow

State/Province

Georgia

ZIP/Postal Code

30260

Country

United States

Facility Name

Price Vision Group

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46260

Country

United States

Facility Name

Specialized Eye Care

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21210

Country

United States

Facility Name

Comprehensive Eye Care, Ltd

City

Washington

State/Province

Missouri

ZIP/Postal Code

63090

Country

United States

Facility Name

Cleveland Eye Clinic

City

Brecksville

State/Province

Ohio

ZIP/Postal Code

44141

Country

United States

Facility Name

Scott & Christie and Associates, PC

City

Cranberry Township

State/Province

Pennsylvania

ZIP/Postal Code

16066

Country

United States

Facility Name

Total Eye Care, PA

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38119

Country

United States

Facility Name

Cataract and Glaucoma Center

City

El Paso

State/Province

Texas

ZIP/Postal Code

79902

Country

United States

Facility Name

Medical Center Ophthalmology Associates

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78240

Country

United States

Facility Name

Hoopes Durrie Rivera Research, LLC

City

Draper

State/Province

Utah

ZIP/Postal Code

84020

Country

United States

Facility Name

The Eye Centers of Racine & Kenosha

City

Kenosha

State/Province

Wisconsin

ZIP/Postal Code

53142

Country

United States

Presbyopia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial