- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03804268
Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With Presbyopia (GEMINI 1)
November 27, 2021 updated by: Allergan
A Phase 3, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of AGN-190584 in Participants With Presbyopia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
323
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Chandler, Arizona, United States, 85224
- Arizona Eye Center
-
Scottsdale, Arizona, United States, 85260
- Schwartz Laser Eye Center
-
-
California
-
Beverly Hills, California, United States, 90210
- Assil Eye Institute
-
Los Angeles, California, United States, 90017
- American Institute of Research
-
Newport Beach, California, United States, 92663
- Eye Research Foundation
-
Rancho Cordova, California, United States, 95670
- Martel Eye Medical Group
-
Sacramento, California, United States, 95815
- Grutzmacher & Lewis, A Medical Corporation DBA Sacramento Eye Consultants
-
-
Colorado
-
Colorado Springs, Colorado, United States, 80919
- Haas Vision Center
-
-
Connecticut
-
Danbury, Connecticut, United States, 06810
- Danbury Eye Physicians and Surgeons P.C.
-
-
Florida
-
Bradenton, Florida, United States, 34209
- The Eye Associates
-
Delray Beach, Florida, United States, 33484
- Bruce Segal, MD
-
Hialeah, Florida, United States, 33012
- Direct Helpers Research Center
-
Hollywood, Florida, United States, 33024
- Research Centers of America
-
Melbourne, Florida, United States, 32901
- Florida Eye Associates
-
Tampa, Florida, United States, 33612
- USF Eye Institute
-
-
Indiana
-
Indianapolis, Indiana, United States, 46260
- Price Vision Group
-
-
Kansas
-
Leawood, Kansas, United States, 66211
- Sabates Eye Centers
-
-
Kentucky
-
Louisville, Kentucky, United States, 40206
- The Eye Care Institute
-
-
Maryland
-
Havre De Grace, Maryland, United States, 21078
- Seidenberg Protzko Eye Associates
-
-
Missouri
-
Kansas City, Missouri, United States, 64111
- Tauber Eye Center
-
-
New York
-
Poughkeepsie, New York, United States, 12603
- Alterman, Modi & Wolter
-
Rochester, New York, United States, 14618
- Rochester Ophthalmological Group, PC
-
-
North Carolina
-
Charlotte, North Carolina, United States, 28204
- Mundorf Eye Center
-
-
Ohio
-
Columbus, Ohio, United States, 43212
- The Ohio State University
-
Powell, Ohio, United States, 43065
- EyeCare Professionals DWA Insight Research Clinic, LLC
-
-
Oregon
-
Portland, Oregon, United States, 97210
- Devers Eye Institute
-
-
Pennsylvania
-
Cranberry Township, Pennsylvania, United States, 16066
- Scott & Christie and Associates, PC
-
-
South Dakota
-
Rapid City, South Dakota, United States, 57701
- Black Hills Regional Eye Institute
-
Sioux Falls, South Dakota, United States, 57108
- Vance Thompson Vision
-
-
Tennessee
-
Memphis, Tennessee, United States, 38104
- Southern College of Optometry
-
Nashville, Tennessee, United States, 37205
- Nashville Vision Associates
-
-
Texas
-
Cedar Park, Texas, United States, 78613
- Hill Country Eye Center
-
Dallas, Texas, United States, 75243
- Key-Whitman Eye Center
-
San Antonio, Texas, United States, 78229
- R and R Eye Research, LLC
-
San Antonio, Texas, United States, 78229
- PNV Clinical Research LLC
-
-
Utah
-
Draper, Utah, United States, 84020
- Hoopes, Durrie, Rivera Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 55 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Vehicle
Participants received one drop of vehicle in each eye, once daily, for up to 30 days.
|
Vehicle, one drop in each eye, once daily, for up to 30 days.
|
EXPERIMENTAL: Pilocarpine HCl Ophthalmic Solution
Participants received one drop of pilocarpine HCl ophthalmic solution 1.25% in each eye, once daily, for up to 30 days.
|
Pilocarpine HCl ophthalmic solution 1.25%, one drop in each eye, once daily, for up to 30 days.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) at Day 30, Hour 3
Time Frame: Baseline (Day 1) to 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.
|
Baseline (Day 1) to Day 30 (Hour 3)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) at Day 30, Hour 6
Time Frame: Baseline (Day 1) to 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.
|
Baseline (Day 1) to Day 30 (Hour 6)
|
Percentage of Participants Gaining 3-lines or More in Mesopic, High-contrast, Binocular, DCNVA at Day 30, Hour 8
Time Frame: Baseline (Day 1) to Day 30 (Hour 8)
|
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.
|
Baseline (Day 1) to Day 30 (Hour 8)
|
Change From Baseline in Mesopic, High-contrast, Binocular DCNVA Letters at Day 30, Hour 0.5
Time Frame: Baseline (Day 1) to 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.
|
Baseline (Day 1) to Day 30 (Hour 0.5)
|
Percentage of Participants Achieving 20/40 or Better in Photopic, High-contrast, Binocular, DCNVA at Day 30, Hour 1
Time Frame: 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.
|
Day 30 (Hour 1)
|
Mean Change From Baseline in Mesopic Near Vision Presbyopia Task-based Questionnaire (NVPTQ) Performance Score at Day 30, Hour 3
Time Frame: Baseline (Day 1) to 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).
|
Baseline (Day 1) to Day 30 (Hour 3)
|
Change From Baseline in Photopic, High-contrast, Binocular Distance-corrected Intermediate Visual Acuity (DCIVA) Letters at Day 30, Hour 3
Time Frame: Baseline (Day 1) to 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.
|
Baseline (Day 1) to Day 30 (Hour 3)
|
Percentage of Participants Gaining 3-lines or More in Mesopic, High-contrast, Binocular, DCNVA at Day 30, Hour 10
Time Frame: Baseline (Day1) to 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.
|
Baseline (Day1) to Day 30 (Hour 10)
|
Change From Baseline in Mesopic, High-contrast, Binocular DCNVA Letters at Day 30, Hour 0.25
Time Frame: Baseline (Day 1) to 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.
|
Baseline (Day 1) to Day 30 (Hour 0.25)
|
Percentage of Participants Achieving 20/40 or Better in Photopic, High-contrast, Binocular, DCNVA at Day 30, Hour 3
Time Frame: 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.
|
Day 30 (Hour 3)
|
Mean Change From Baseline in Mesopic NVPTQ Satisfaction Score at Day 30, Hour 3
Time Frame: Baseline (Day 1) to 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.
|
Baseline (Day 1) to Day 30 (Hour 3)
|
Mean Change From Baseline in Presbyopia Impact and Coping Questionnaire (PICQ) Coping Score at Day 30, Hour 3
Time Frame: Baseline (Day 1) to 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.
|
Baseline (Day 1) to Day 30 (Hour 3)
|
Mean Change From Baseline in PICQ Impact Score at Day 30, Hour 3
Time Frame: Baseline (Day 1) to 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.
|
Baseline (Day 1) to Day 30 (Hour 3)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 21, 2018
Primary Completion (ACTUAL)
October 31, 2019
Study Completion (ACTUAL)
October 31, 2019
Study Registration Dates
First Submitted
January 11, 2019
First Submitted That Met QC Criteria
January 11, 2019
First Posted (ACTUAL)
January 15, 2019
Study Record Updates
Last Update Posted (ACTUAL)
December 28, 2021
Last Update Submitted That Met QC Criteria
November 27, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Eye Diseases
- Refractive Errors
- Presbyopia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Cholinergic Agonists
- Pharmaceutical Solutions
- Miotics
- Muscarinic Agonists
- Ophthalmic Solutions
- Pilocarpine
Other Study ID Numbers
- 1883-301-013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Presbyopia
-
Johnson & Johnson Vision Care, Inc.CompletedPresbyopia CorrectionUnited Kingdom
-
Bausch & Lomb IncorporatedCompletedMyopia and Hyperopia and PresbyopiaUnited States
-
Technolas Perfect Vision GmbHUnknownHyperopic PresbyopiaIreland
-
Lee, Steven, M.D.CompletedMyopia, | Hyperopia, | Astigmatism, | Presbyopia, | Eye Strain,
-
Allotex, Inc.RecruitingPresbyopiaCzechia, Ireland, Turkey, United Kingdom
-
Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.LENZ Therapeutics, IncRecruiting
-
Coopervision, Inc.Centre for Ocular Research & Education, CanadaRecruitingPresbyopiaUnited States, Canada
-
Optall VisionRecruiting
-
Allotex, Inc.TerminatedPresbyopiaBelgium, Ireland, United Kingdom
-
Coopervision, Inc.CORECompletedPresbyopiaUnited States, Canada
Clinical Trials on Vehicle
-
Haus BioceuticalsCompletedEczema | Atopic DermatitisIndia
-
PfizerCompleted
-
Bausch Health Americas, Inc.Dow Pharmaceutical SciencesCompleted
-
Instituto Universitario de Oftalmobiología Aplicada...Completed
-
LEO PharmaCompleted
-
Bausch Health Americas, Inc.Dow Pharmaceutical SciencesCompleted
-
Johns Hopkins Bloomberg School of Public HealthCompletedObesity | Childhood Obesity | Dietary Habits | Water; Lack of | Feeding Behavior | Mother-Child RelationsUnited States
-
Dr. Reddy's Laboratories LimitedSyneos Health; AccelovanceCompletedHead Lice InfestationUnited States
-
University of British ColumbiaUnknownCicatrix | Scar | Keloid | Hypertrophic Scar | Skin Graft Scar | Skin Graft Complications | Donor Site ComplicationCanada
-
Patagonia Pharmaceuticals, LLCCompletedCongenital IchthyosisUnited States