Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With Presbyopia
NCT ID: NCT03804268
Last Updated: 2021-12-28
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
323 participants
INTERVENTIONAL
2018-12-21
2019-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Vehicle
Participants received one drop of vehicle in each eye, once daily, for up to 30 days.
Vehicle
Vehicle, one drop in each eye, once daily, for up to 30 days.
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
Pilocarpine HCl ophthalmic solution 1.25%, one drop in each eye, once daily, for up to 30 days.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Vehicle
Vehicle, one drop in each eye, once daily, for up to 30 days.
Pilocarpine HCl Ophthalmic Solution
Pilocarpine HCl ophthalmic solution 1.25%, one drop in each eye, once daily, for up to 30 days.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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
40 Years
55 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Allergan
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Eleonora Safyan
Role: STUDY_DIRECTOR
Allergan
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Arizona Eye Center
Chandler, Arizona, United States
Schwartz Laser Eye Center
Scottsdale, Arizona, United States
Assil Eye Institute
Beverly Hills, California, United States
American Institute of Research
Los Angeles, California, United States
Eye Research Foundation
Newport Beach, California, United States
Martel Eye Medical Group
Rancho Cordova, California, United States
Grutzmacher & Lewis, A Medical Corporation DBA Sacramento Eye Consultants
Sacramento, California, United States
Haas Vision Center
Colorado Springs, Colorado, United States
Danbury Eye Physicians and Surgeons P.C.
Danbury, Connecticut, United States
The Eye Associates
Bradenton, Florida, United States
Bruce Segal, MD
Delray Beach, Florida, United States
Direct Helpers Research Center
Hialeah, Florida, United States
Research Centers of America
Hollywood, Florida, United States
Florida Eye Associates
Melbourne, Florida, United States
USF Eye Institute
Tampa, Florida, United States
Price Vision Group
Indianapolis, Indiana, United States
Sabates Eye Centers
Leawood, Kansas, United States
The Eye Care Institute
Louisville, Kentucky, United States
Seidenberg Protzko Eye Associates
Havre de Grace, Maryland, United States
Tauber Eye Center
Kansas City, Missouri, United States
Alterman, Modi & Wolter
Poughkeepsie, New York, United States
Rochester Ophthalmological Group, PC
Rochester, New York, United States
Mundorf Eye Center
Charlotte, North Carolina, United States
The Ohio State University
Columbus, Ohio, United States
EyeCare Professionals DWA Insight Research Clinic, LLC
Powell, Ohio, United States
Devers Eye Institute
Portland, Oregon, United States
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States
Vance Thompson Vision
Sioux Falls, South Dakota, United States
Southern College of Optometry
Memphis, Tennessee, United States
Nashville Vision Associates
Nashville, Tennessee, United States
Hill Country Eye Center
Cedar Park, Texas, United States
Key-Whitman Eye Center
Dallas, Texas, United States
PNV Clinical Research LLC
San Antonio, Texas, United States
R and R Eye Research, LLC
San Antonio, Texas, United States
Hoopes, Durrie, Rivera Research
Draper, Utah, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Lievens CW, Hom MM, McLaurin EB, Yuan J, Safyan E, Liu H. Pilocarpine HCl 1.25% for treatment of presbyopia after laser vision correction: pooled analysis of two phase 3 randomized trials (GEMINI 1 and 2). J Cataract Refract Surg. 2024 Jan 1;50(1):57-63. doi: 10.1097/j.jcrs.0000000000001313.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1883-301-013
Identifier Type: -
Identifier Source: org_study_id