Back to results

Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With Presbyopia (GEMINI 1)

Primary Purpose

Presbyopia

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Vehicle

Pilocarpine HCl Ophthalmic Solution

About this trial

This is an interventional treatment trial for Presbyopia

Eligibility Criteria

40 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Subjective complaints of poor near vision that impact activities of daily living

Exclusion Criteria:

History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery, radial keratotomy, or any intraocular surgery
Use of any topical ophthalmic medications, including artificial tears other than the study medications during the study
Use of temporary or permanent punctal plugs or history of punctal cautery in one or both eyes
Corneal abnormalities (including keratoconus, corneal scar, Fuchs' endothelial dystrophy, guttata, or edema) in either eye that are likely to interfere with visual acuity
Narrow iridocorneal angles (Shaffer grade ≤2 or lower on gonioscopy examination), history of angle-closure glaucoma, or previous iridotomy
Diagnosis of any type of glaucoma or ocular hypertension

Sites / Locations

Arizona Eye Center
Schwartz Laser Eye Center
Assil Eye Institute
American Institute of Research
Eye Research Foundation
Martel Eye Medical Group
Grutzmacher & Lewis, A Medical Corporation DBA Sacramento Eye Consultants
Haas Vision Center
Danbury Eye Physicians and Surgeons P.C.
The Eye Associates
Bruce Segal, MD
Direct Helpers Research Center
Research Centers of America
Florida Eye Associates
USF Eye Institute
Price Vision Group
Sabates Eye Centers
The Eye Care Institute
Seidenberg Protzko Eye Associates
Tauber Eye Center
Alterman, Modi & Wolter
Rochester Ophthalmological Group, PC
Mundorf Eye Center
The Ohio State University
EyeCare Professionals DWA Insight Research Clinic, LLC
Devers Eye Institute
Scott & Christie and Associates, PC
Black Hills Regional Eye Institute
Vance Thompson Vision
Southern College of Optometry
Nashville Vision Associates
Hill Country Eye Center
Key-Whitman Eye Center
PNV Clinical Research LLC
R and R Eye Research, LLC
Hoopes, Durrie, Rivera Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Vehicle

Pilocarpine HCl Ophthalmic Solution

Arm Description

Participants received one drop of vehicle in each eye, once daily, for up to 30 days.

Participants received one drop of pilocarpine HCl ophthalmic solution 1.25% in each eye, once daily, for up to 30 days.

Outcomes

Primary Outcome Measures

Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) at Day 30, Hour 3

Visual acuity for near (40 centimeters (cm)) target was measured in mesopic conditions using an eye chart. Mesopic condition was defined as low lighting 3.2 to 3.5 candelas per square meter (cd/m^2) measured at the target. Percentage of participants with 3 lines or more improvement from Baseline in mesopic, high-contrast DCNVA are reported.

Secondary Outcome Measures

Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) at Day 30, Hour 6

Visual acuity for near (40 cm) target was measured in mesopic conditions using an eye chart. Mesopic condition was defined as low lighting 3.2 to 3.5 candelas per square meter measured at the target. Percentage of participants with 3 lines or more improvement from Baseline in mesopic, high-contrast DCNVA are reported.

Percentage of Participants Gaining 3-lines or More in Mesopic, High-contrast, Binocular, DCNVA at Day 30, Hour 8

Change From Baseline in Mesopic, High-contrast, Binocular DCNVA Letters at Day 30, Hour 0.5

Visual acuity for near (40 cm) target was measured in mesopic conditions using an eye chart. Mesopic condition was defined as low lighting 3.2 to 3.5 cd/m^2 measured at the target. A positive change from Baseline indicates improvement in visual acuity. Mixed effect model for repeated measures (MMRM) was used for analyses.

Percentage of Participants Achieving 20/40 or Better in Photopic, High-contrast, Binocular, DCNVA at Day 30, Hour 1

Visual acuity for near (40 cm) target was measured in photopic conditions using an eye chart. Photopic condition was defined as high lighting ≥80 cd/m^2 measured at the target. Percentage of participants achieving 20/40 or better in photopic, high-contrast, binocular, DCNVA are reported.

Mean Change From Baseline in Mesopic Near Vision Presbyopia Task-based Questionnaire (NVPTQ) Performance Score at Day 30, Hour 3

NVPTQ had 12 questions on 4 reading tasks(reading a paragraph from book, excerpts from an article in newspaper, portion of a nutrition label, and a section from restaurant menu). Participants completed specific reading tasks under mesopic conditions without any near-vision correction and answered 3 questions for each task, rating their vision-related reading ability as 0=I could not read any text due to problems seeing up close,1=poor,2=fair,3=good,4=very good,5=excellent;impact of squinting on performance as 0=No,I did not squint, 1=Yes,squinting helped me read some/all text, 2=Yes,but I still could not read any of the text; and satisfaction as 0=very dissatisfied to 4=very satisfied. The score based on vision related ability and impact of squinting=(Book testlet+Newspaper testlet+Menu testlet+Nutrition Label testlet)/(testlets with non-missing responses), total possible score of 0-5. Higher scores=better outcomes;positive change from Baseline=improved performance(reading ability).

Change From Baseline in Photopic, High-contrast, Binocular Distance-corrected Intermediate Visual Acuity (DCIVA) Letters at Day 30, Hour 3

Visual acuity for intermediate (66 cm) target was measured in photopic conditions using an eye chart. Photopic condition was defined as high lighting ≥80 cd/m^2 measured at the target. A positive change from Baseline indicates improvement in visual acuity. MMRM was used for analyses.

Percentage of Participants Gaining 3-lines or More in Mesopic, High-contrast, Binocular, DCNVA at Day 30, Hour 10

Visual acuity for near (40cm) target was measured in mesopic conditions using an eye chart. Mesopic condition was defined as low lighting 3.2 to 3.5 cd/m^2measured at the target. Percentage of participants with 3 lines or more improvement from Baseline in mesopic, high-contrast, binocular DCNVA are reported.

Change From Baseline in Mesopic, High-contrast, Binocular DCNVA Letters at Day 30, Hour 0.25

Visual acuity for near (40 cm) target was measured in mesopic conditions. Mesopic condition was defined as low lighting 3.2 to 3.5 cd/m^2 measured at the target. A positive change from Baseline indicates improvement in visual acuity. MMRM was used for analyses.

Percentage of Participants Achieving 20/40 or Better in Photopic, High-contrast, Binocular, DCNVA at Day 30, Hour 3

Visual acuity for near (40 cm) target was measured in mesopic conditions using an eye chart. Photopic condition was defined as high lighting ≥80 cd/m^2 measured at the target. Percentage of participants achieving 20/40 or better in photopic, high-contrast, binocular, DCNVA are reported.

Mean Change From Baseline in Mesopic NVPTQ Satisfaction Score at Day 30, Hour 3

NVPTQ had 12 questions on 4 reading tasks(reading a paragraph from book, excerpts from an article in newspaper, portion of a nutrition label, and a section from restaurant menu). Participants completed specific reading tasks under mesopic conditions without any near-vision correction and answered 3 questions for each task, rating their vision-related reading ability as 0=I could not read any text due to problems seeing up close to 5=excellent; impact of squinting on performance as 0=No, I did not squint, 1=Yes, squinting helped me read some/all text, 2=Yes, but I still could not read any of the text; and satisfaction as 0=very dissatisfied,1=dissatisfied,2=neither satisfied nor dissatisfied,3=satisfied, 4=very satisfied. The score based on satisfaction items=(Book testlet+Newspaper testlet+Menu testlet+Nutrition Label testlet)/(testlets with non-missing responses) for a total possible score of 0 to 4. Higher scores=better outcomes; a positive change from Baseline=higher satisfaction.

Mean Change From Baseline in Presbyopia Impact and Coping Questionnaire (PICQ) Coping Score at Day 30, Hour 3

PICQ=20 questions about impact experienced by participants due to their problems over past 7 days.PICQ Coping domain had 8 items: 1:Normal-sized text,2:Small-sized text,3:Information on a computer,4:Information on a cell phone,5:Increase font size,6:Use glasses to read close,12:Hold reading materials farther out/closer,13:Squint to read. Each item had response categories:0=never to 4=all the time. Items 3, 4, 5, and 6 had additional response categories with values of 9/10 to indicate the question is not applicable to participant and were assigned missing values.PICQ Coping Score:(Item 1,2 Testlet+Item 3,4 Testlet+Item 5+Item 6+Item 12+Item 13)/non-missing responses to the 6 components of coping score where Items 1,2 Testlet=(Item1+Item2)/non-missing responses to Items 1,2;Items 3,4 Testlet=(Item3+Item4)/non-missing responses to Items 3, 4. Score ranges:0=to least amount of coping to 4=greatest amount of coping. Higher scores=poorer outcome; a negative change from Baseline=improvement.

Mean Change From Baseline in PICQ Impact Score at Day 30, Hour 3

PICQ had 20 questions about impact experienced by participants due to their problems seeing up over past 7 days. PICQ Impact domain had 6 items: Item 9:Rely on others,15:rest eyes,16:Feel older,17:Feel self-conscious,19:Take longer to complete a task,20:Inconvenient. First 5 impacts items included response categories: 0=never to 4=all the time. Item 20 had response categories: 0=not at all to 4=extremely. Item 9 included an additional response category with a value of 9 to indicate question was not applicable to participant and the responses were assigned missing values. PICQ Impacts Score=[(Item9+Item15+Items16,17Testlet+Item19+Item20)/(nonmissing responses to 5 components of impacts score)] where Items 16,17 Testlet=(Item16+Item17)/non-missing responses to Items 16 and 17. PICQ Impact score ranges from 0 to 4; with 0=least amount of impacts to 4=greatest amount of impacts. Higher scores correspond to poorer outcomes. A negative change from Baseline=improvement.

Full Information

NCT ID

NCT03804268

First Posted

January 11, 2019

Last Updated

November 27, 2021

Sponsor

Allergan

1. Study Identification

Unique Protocol Identification Number

NCT03804268

Brief Title

Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With Presbyopia

Acronym

GEMINI 1

Official Title

A Phase 3, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of AGN-190584 in Participants With Presbyopia

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

December 21, 2018 (Actual)

Primary Completion Date

October 31, 2019 (Actual)

Study Completion Date

October 31, 2019 (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

5. Study Description

Brief Summary

A study to evaluate the efficacy, safety, and pharmacokinetics of pilocarpine hydrochloride (HCl) ophthalmic solution (AGN-190584) when administered bilaterally, once daily for 30 days in participants with presbyopia.

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 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

323 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vehicle

Arm Type

Placebo Comparator

Arm Description

Participants received one drop of vehicle in each eye, once daily, for up to 30 days.

Arm Title

Pilocarpine HCl Ophthalmic Solution

Arm Type

Experimental

Arm Description

Participants received one drop of pilocarpine HCl ophthalmic solution 1.25% in each eye, once daily, for up to 30 days.

Intervention Type

Other

Intervention Name(s)

Vehicle

Intervention Description

Vehicle, one drop in each eye, once daily, for up to 30 days.

Intervention Type

Drug

Intervention Name(s)

Pilocarpine HCl Ophthalmic Solution

Other Intervention Name(s)

AGN-190584, VUITY

Intervention Description

Pilocarpine HCl ophthalmic solution 1.25%, one drop in each eye, once daily, for up to 30 days.

Primary Outcome Measure Information:

Title

Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) at Day 30, Hour 3

Description

Time Frame

Baseline (Day 1) to Day 30 (Hour 3)

Secondary Outcome Measure Information:

Title

Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) at Day 30, Hour 6

Description

Time Frame

Baseline (Day 1) to Day 30 (Hour 6)

Title

Percentage of Participants Gaining 3-lines or More in Mesopic, High-contrast, Binocular, DCNVA at Day 30, Hour 8

Description

Time Frame

Baseline (Day 1) to Day 30 (Hour 8)

Title

Change From Baseline in Mesopic, High-contrast, Binocular DCNVA Letters at Day 30, Hour 0.5

Description

Time Frame

Baseline (Day 1) to Day 30 (Hour 0.5)

Title

Percentage of Participants Achieving 20/40 or Better in Photopic, High-contrast, Binocular, DCNVA at Day 30, Hour 1

Description

Time Frame

Day 30 (Hour 1)

Title

Mean Change From Baseline in Mesopic Near Vision Presbyopia Task-based Questionnaire (NVPTQ) Performance Score at Day 30, Hour 3

Description

Time Frame

Baseline (Day 1) to Day 30 (Hour 3)

Title

Change From Baseline in Photopic, High-contrast, Binocular Distance-corrected Intermediate Visual Acuity (DCIVA) Letters at Day 30, Hour 3

Description

Time Frame

Baseline (Day 1) to Day 30 (Hour 3)

Title

Percentage of Participants Gaining 3-lines or More in Mesopic, High-contrast, Binocular, DCNVA at Day 30, Hour 10

Description

Visual acuity for near (40cm) target was measured in mesopic conditions using an eye chart. Mesopic condition was defined as low lighting 3.2 to 3.5 cd/m^2measured at the target. Percentage of participants with 3 lines or more improvement from Baseline in mesopic, high-contrast, binocular DCNVA are reported.

Time Frame

Baseline (Day1) to Day 30 (Hour 10)

Title

Change From Baseline in Mesopic, High-contrast, Binocular DCNVA Letters at Day 30, Hour 0.25

Description

Time Frame

Baseline (Day 1) to Day 30 (Hour 0.25)

Title

Percentage of Participants Achieving 20/40 or Better in Photopic, High-contrast, Binocular, DCNVA at Day 30, Hour 3

Description

Time Frame

Day 30 (Hour 3)

Title

Mean Change From Baseline in Mesopic NVPTQ Satisfaction Score at Day 30, Hour 3

Description

NVPTQ had 12 questions on 4 reading tasks(reading a paragraph from book, excerpts from an article in newspaper, portion of a nutrition label, and a section from restaurant menu). Participants completed specific reading tasks under mesopic conditions without any near-vision correction and answered 3 questions for each task, rating their vision-related reading ability as 0=I could not read any text due to problems seeing up close to 5=excellent; impact of squinting on performance as 0=No, I did not squint, 1=Yes, squinting helped me read some/all text, 2=Yes, but I still could not read any of the text; and satisfaction as 0=very dissatisfied,1=dissatisfied,2=neither satisfied nor dissatisfied,3=satisfied, 4=very satisfied. The score based on satisfaction items=(Book testlet+Newspaper testlet+Menu testlet+Nutrition Label testlet)/(testlets with non-missing responses) for a total possible score of 0 to 4. Higher scores=better outcomes; a positive change from Baseline=higher satisfaction.

Time Frame

Baseline (Day 1) to Day 30 (Hour 3)

Title

Mean Change From Baseline in Presbyopia Impact and Coping Questionnaire (PICQ) Coping Score at Day 30, Hour 3

Description

Time Frame

Baseline (Day 1) to Day 30 (Hour 3)

Title

Mean Change From Baseline in PICQ Impact Score at Day 30, Hour 3

Description

Time Frame

Baseline (Day 1) to Day 30 (Hour 3)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: - Subjective complaints of poor near vision that impact activities of daily living Exclusion Criteria: History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery, radial keratotomy, or any intraocular surgery Use of any topical ophthalmic medications, including artificial tears other than the study medications during the study Use of temporary or permanent punctal plugs or history of punctal cautery in one or both eyes Corneal abnormalities (including keratoconus, corneal scar, Fuchs' endothelial dystrophy, guttata, or edema) in either eye that are likely to interfere with visual acuity Narrow iridocorneal angles (Shaffer grade ≤2 or lower on gonioscopy examination), history of angle-closure glaucoma, or previous iridotomy Diagnosis of any type of glaucoma or ocular hypertension

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eleonora Safyan

Organizational Affiliation

Allergan

Official's Role

Study Director

Facility Information:

Facility Name

Arizona Eye Center

City

Chandler

State/Province

Arizona

ZIP/Postal Code

85224

Country

United States

Facility Name

Schwartz Laser Eye Center

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85260

Country

United States

Facility Name

Assil Eye Institute

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90210

Country

United States

Facility Name

American Institute of Research

City

Los Angeles

State/Province

California

ZIP/Postal Code

90017

Country

United States

Facility Name

Eye Research Foundation

City

Newport Beach

State/Province

California

ZIP/Postal Code

92663

Country

United States

Facility Name

Martel Eye Medical Group

City

Rancho Cordova

State/Province

California

ZIP/Postal Code

95670

Country

United States

Facility Name

Grutzmacher & Lewis, A Medical Corporation DBA Sacramento Eye Consultants

City

Sacramento

State/Province

California

ZIP/Postal Code

95815

Country

United States

Facility Name

Haas Vision Center

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80919

Country

United States

Facility Name

Danbury Eye Physicians and Surgeons P.C.

City

Danbury

State/Province

Connecticut

ZIP/Postal Code

06810

Country

United States

Facility Name

The Eye Associates

City

Bradenton

State/Province

Florida

ZIP/Postal Code

34209

Country

United States

Facility Name

Bruce Segal, MD

City

Delray Beach

State/Province

Florida

ZIP/Postal Code

33484

Country

United States

Facility Name

Direct Helpers Research Center

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33012

Country

United States

Facility Name

Research Centers of America

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33024

Country

United States

Facility Name

Florida Eye Associates

City

Melbourne

State/Province

Florida

ZIP/Postal Code

32901

Country

United States

Facility Name

USF Eye Institute

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Price Vision Group

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46260

Country

United States

Facility Name

Sabates Eye Centers

City

Leawood

State/Province

Kansas

ZIP/Postal Code

66211

Country

United States

Facility Name

The Eye Care Institute

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40206

Country

United States

Facility Name

Seidenberg Protzko Eye Associates

City

Havre De Grace

State/Province

Maryland

ZIP/Postal Code

21078

Country

United States

Facility Name

Tauber Eye Center

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64111

Country

United States

Facility Name

Alterman, Modi & Wolter

City

Poughkeepsie

State/Province

New York

ZIP/Postal Code

12603

Country

United States

Facility Name

Rochester Ophthalmological Group, PC

City

Rochester

State/Province

New York

ZIP/Postal Code

14618

Country

United States

Facility Name

Mundorf Eye Center

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28204

Country

United States

Facility Name

The Ohio State University

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43212

Country

United States

Facility Name

EyeCare Professionals DWA Insight Research Clinic, LLC

City

Powell

State/Province

Ohio

ZIP/Postal Code

43065

Country

United States

Facility Name

Devers Eye Institute

City

Portland

State/Province

Oregon

ZIP/Postal Code

97210

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

Black Hills Regional Eye Institute

City

Rapid City

State/Province

South Dakota

ZIP/Postal Code

57701

Country

United States

Facility Name

Vance Thompson Vision

City

Sioux Falls

State/Province

South Dakota

ZIP/Postal Code

57108

Country

United States

Facility Name

Southern College of Optometry

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38104

Country

United States

Facility Name

Nashville Vision Associates

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37205

Country

United States

Facility Name

Hill Country Eye Center

City

Cedar Park

State/Province

Texas

ZIP/Postal Code

78613

Country

United States

Facility Name

Key-Whitman Eye Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75243

Country

United States

Facility Name

PNV Clinical Research LLC

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

R and R Eye Research, LLC

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Hoopes, Durrie, Rivera Research

City

Draper

State/Province

Utah

ZIP/Postal Code

84020

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35848990

Citation

Westheimer G. Topical Review: Pilocarpine-induced Miosis as Help for Early Presbyopes? Optom Vis Sci. 2022 Aug 1;99(8):632-634. doi: 10.1097/OPX.0000000000001924. Epub 2022 Jul 14.

Results Reference

derived

PubMed Identifier

35238902

Citation

Waring GO 4th, Price FW Jr, Wirta D, McCabe C, Moshirfar M, Guo Q, Gore A, Liu H, Safyan E, Robinson MR. Safety and Efficacy of AGN-190584 in Individuals With Presbyopia: The GEMINI 1 Phase 3 Randomized Clinical Trial. JAMA Ophthalmol. 2022 Apr 1;140(4):363-371. doi: 10.1001/jamaophthalmol.2022.0059.

Results Reference

derived

Learn more about this trial

Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With Presbyopia

We'll reach out to this number within 24 hrs