A Study to Assess Safety and Efficacy in Participants Age 40 to 55 With Presbyopia (Old Eye) Who Receive AGN-190584 in Both Eyes Twice Daily
NCT ID: NCT04983589
Last Updated: 2023-03-21
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
230 participants
INTERVENTIONAL
2021-09-02
2022-02-11
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
AGN-190584 is an investigational drug being developed for the treatment of presbyopia. Participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to vehicle. Around 200 participants age 40-55 years with a diagnosis of presbyopia will be enrolled in the study in approximately 20 sites in the United States.
Participants will receive AGN-190584 or vehicle in each eye twice daily for 14 days.
There may be additional procedures for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a doctor's office. The effect of the treatment will be checked by medical assessments, vision/eye tests, checking for side effects and completing questionnaires.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of AGN-190584 Eye Drops to Assess Safety and Efficacy in Participants Aged 40-80 Years With Pseudophakic Presbyopia
NCT05393089
A Safety, Efficacy and Pharmacokinetic Study of AGN-199201 and AGN-190584 in Patients With Presbyopia
NCT02780115
A Study of the Concurrent Use of AGN-190584 and AGN-199201 in Participants With Presbyopia
NCT02595528
Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With Presbyopia
NCT03804268
Safety and Efficacy of AGN-199201 and AGN-190584 in Patients With Presbyopia
NCT02197806
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
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Vehicle
Participants received vehicle, one drop bilaterally (in each eye), twice daily (BID), with a gap of 6 hours between both doses, for up to 14 days.
Vehicle
Oxymetazoline HCl and pilocarpine HCl placebo ocular drops.
AGN-190584
AGN-190584 ophthalmic solution, one drop bilaterally (in each eye), BID, with a gap of 6 hours between both doses, for up to 14 days.
Pilocarpine HCl
Pilocarpine HCl ophthalmic solution 1.25% ocular drops.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pilocarpine HCl
Pilocarpine HCl ophthalmic solution 1.25% ocular drops.
Vehicle
Oxymetazoline HCl and pilocarpine HCl placebo ocular drops.
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
* 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.
* History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery, radial keratotomy, or any intraocular surgery.
* Use of temporary or permanent punctal plugs or history of punctal cautery in one or both eyes.
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.
ALLERGAN INC.
Role: STUDY_DIRECTOR
Allergan
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Empire Eye and Laser /ID# 231433
Bakersfield, California, United States
Global Research Management /ID# 231300
Glendale, California, United States
United Medical Research Institute /ID# 233982
Inglewood, California, United States
North Valley Eye Medical Group, Inc. /ID# 231270
Mission Hills, California, United States
The Eye Research Foundation /ID# 231274
Newport Beach, California, United States
Martel Eye Medical Group /ID# 231332
Rancho Cordova, California, United States
Nature Coast Clinical Research - Crystal River /ID# 231298
Crystal River, Florida, United States
Bruce Segal, MD /ID# 231413
Delray Beach, Florida, United States
Clayton Eye Clinical Research, LLC /ID# 231243
Morrow, Georgia, United States
Jacksoneye, SC /ID# 231374
Lake Villa, Illinois, United States
Price Vision Group /ID# 231261
Indianapolis, Indiana, United States
Kannarr Eye Care /ID# 231363
Pittsburg, Kansas, United States
Cincinnati Eye Institute- Edgewood /ID# 231356
Edgewood, Kentucky, United States
The Eye Care Institute /ID# 231275
Louisville, Kentucky, United States
Rochester Ophthalmological Group PC /ID# 231371
Rochester, New York, United States
Southern College of Optometry /ID# 231325
Memphis, Tennessee, United States
Total Eye Care, PA /ID# 231245
Memphis, Tennessee, United States
Advancing Vision Research /ID# 231244
Smyrna, Tennessee, United States
Hill Country Eye Center /ID# 231293
Cedar Park, Texas, United States
The Cataract & Glaucoma Center /ID# 231292
El Paso, Texas, United States
Eye associates /ID# 231262
San Antonio, Texas, United States
Hoopes, Durrie, Rivera Research /ID# 231273
Draper, Utah, United States
Country Hills Eye Center /ID# 231414
Ogden, Utah, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
M21-195
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.