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
Public ClinicalTrials.gov record NCT04983589. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of BID Dosing of AGN-190584 in Subjects With Presbyopia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Currently available treatments for presbyopia (old eye) include nonsurgical options (spectacles or contact lenses) and surgical options, however, each has its own risks and limitations. The purpose of this study is to evaluate how effective AGN-190584 is in treating presbyopia compared to vehicle (placebo). 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.
Study identification
- NCT ID
- NCT04983589
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 230 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 40 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 1, 2021
- Primary completion
- Feb 10, 2022
- Completion
- Feb 10, 2022
- Last update posted
- Mar 20, 2023
2021 – 2022
United States locations
- U.S. sites
- 23
- U.S. states
- 11
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Empire Eye and Laser /ID# 231433 | Bakersfield | California | 93309-0637 | — |
| Global Research Management /ID# 231300 | Glendale | California | 91204-2500 | — |
| United Medical Research Institute /ID# 233982 | Inglewood | California | 90301 | — |
| North Valley Eye Medical Group, Inc. /ID# 231270 | Mission Hills | California | 91345-1200 | — |
| The Eye Research Foundation /ID# 231274 | Newport Beach | California | 92663-3637 | — |
| Martel Eye Medical Group /ID# 231332 | Rancho Cordova | California | 95670-2968 | — |
| Nature Coast Clinical Research - Crystal River /ID# 231298 | Crystal River | Florida | 34429 | — |
| Bruce Segal, MD /ID# 231413 | Delray Beach | Florida | 33484-6540 | — |
| Clayton Eye Clinical Research, LLC /ID# 231243 | Morrow | Georgia | 30260-4180 | — |
| Jacksoneye, SC /ID# 231374 | Lake Villa | Illinois | 60046-8563 | — |
| Price Vision Group /ID# 231261 | Indianapolis | Indiana | 46260-5381 | — |
| Kannarr Eye Care /ID# 231363 | Pittsburg | Kansas | 66762-2620 | — |
| Cincinnati Eye Institute- Edgewood /ID# 231356 | Edgewood | Kentucky | 41017-3415 | — |
| The Eye Care Institute /ID# 231275 | Louisville | Kentucky | 40206-1738 | — |
| Rochester Ophthalmological Group PC /ID# 231371 | Rochester | New York | 14618-2616 | — |
| Southern College of Optometry /ID# 231325 | Memphis | Tennessee | 38104-2211 | — |
| Total Eye Care, PA /ID# 231245 | Memphis | Tennessee | 38119-5745 | — |
| Advancing Vision Research /ID# 231244 | Smyrna | Tennessee | 37167 | — |
| Hill Country Eye Center /ID# 231293 | Cedar Park | Texas | 78613-7651 | — |
| The Cataract & Glaucoma Center /ID# 231292 | El Paso | Texas | 79902-1444 | — |
| Eye associates /ID# 231262 | San Antonio | Texas | 78229 | — |
| Hoopes, Durrie, Rivera Research /ID# 231273 | Draper | Utah | 84020-7133 | — |
| Country Hills Eye Center /ID# 231414 | Ogden | Utah | 84403-2200 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04983589, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 20, 2023 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04983589 live on ClinicalTrials.gov.