Study of AGN-190584 Eye Drops to Assess Safety and Efficacy in Participants Aged 40-80 Years With Pseudophakic Presbyopia
Public ClinicalTrials.gov record NCT05393089. 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 2, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of AGN-190584 in Subjects With Pseudophakic Presbyopia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Presbyopia is a condition in which the eye exhibits a diminished ability to focus on near objects with increasing age. This study will assess the safety and exploratory efficacy of AGN-190584 is in treating participants with pseudophakic presbyopia. AGN-190584 is approved (in the United States) for use in adults with presbyopia (including those who are pseudophakic) and this study is being conducted to better understand the safety and efficacy in the pseudophakic presbyopia population. This study is double-masked meaning that neither the participants nor the study doctors will know who will be given AGN-190584 and who will be given vehicle (does not contain treatment drug). Study doctors put the participants in 1 of the 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to vehicle. Approximately 150 participants aged 40-80 years with pseudophakic presbyopia will be enrolled in approximately 30 sites in the US. Participants will receive eye drops of AGN-190584 or vehicle once daily in the morning in each eye for 14 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study. The effect of the treatment will be evaluated by medical assessments, checking for side effects and completing questionnaires.
Study identification
- NCT ID
- NCT05393089
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- Not listed
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 40 Years to 80 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
- Jun 8, 2022
- Primary completion
- Apr 3, 2023
- Completion
- Apr 3, 2023
- Last update posted
- Jun 28, 2022
2022 – 2023
United States locations
- U.S. sites
- 32
- U.S. states
- 16
- U.S. cities
- 30
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Trinity Research Group /ID# 243541 | Dothan | Alabama | 36301 | — |
| Arizona Eye Center /ID# 243897 | Chandler | Arizona | 85224 | — |
| Global Research Management /ID# 243544 | Glendale | California | 91204-2500 | — |
| United Medical Research Institute /ID# 243531 | Inglewood | California | 90301 | — |
| Salvay Vision /ID# 243828 | Newport Beach | California | 92663-3600 | — |
| The Eye Research Foundation /ID# 243524 | Newport Beach | California | 92663-3637 | — |
| Sacramento Eye Consultants /ID# 243538 | Sacramento | California | 95815 | — |
| Nature Coast Clinical Research - Crystal River /ID# 243519 | Crystal River | Florida | 34429 | — |
| Segal Drug Trials, Inc /ID# 243521 | Delray Beach | Florida | 33484 | — |
| Eye Associates of Fort Meyers /ID# 243545 | Fort Myers | Florida | 33901 | — |
| Levenson Eye Associates Inc. /ID# 243532 | Jacksonville | Florida | 32204 | — |
| Emory University /ID# 243534 | Atlanta | Georgia | 30322-1013 | — |
| Clayton Eye Clinical Research, LLC /ID# 243530 | Morrow | Georgia | 30260-4180 | — |
| Coastal Research Associates /ID# 243525 | Roswell | Georgia | 30076 | — |
| Kannarr Eye Care /ID# 243542 | Pittsburg | Kansas | 66762-2620 | — |
| Cincinnati Eye Institute- Edgewood /ID# 243810 | Edgewood | Kentucky | 41017-3415 | — |
| The Eye Care Institute /ID# 243588 | Louisville | Kentucky | 40206-1738 | — |
| Fraser Eye Center /ID# 244038 | Fraser | Michigan | 48026 | — |
| Silverstein Eye Centers /ID# 243546 | Kansas City | Missouri | 64034 | — |
| Eye Associates of North Jersey /ID# 243913 | Dover | New Jersey | 07801-1629 | — |
| Northern New Jersey Eye Institute PA /ID# 243522 | South Orange | New Jersey | 07079-1855 | — |
| Rochester Ophthalmological Group PC /ID# 243539 | Rochester | New York | 14618-2616 | — |
| EyeCare Professionals Inc /ID# 243938 | Powell | Ohio | 43065 | — |
| Scott and Christie and Associates /ID# 243548 | Cranberry Township | Pennsylvania | 16066 | — |
| University Eye Surgeons /ID# 243926 | Maryville | Tennessee | 37805 | — |
| Advancing Vision Research /ID# 243529 | Smyrna | Tennessee | 37167 | — |
| Key-Whitman Eye Center /ID# 243928 | Dallas | Texas | 75243 | — |
| Eye associates /ID# 243526 | San Antonio | Texas | 78229 | — |
| Parkhurst Nuvision /ID# 244041 | San Antonio | Texas | 78229 | — |
| Hoopes, Durrie, Rivera Research /ID# 243535 | Draper | Utah | 84020-7133 | — |
| Country Hills Eye Center /ID# 243520 | Ogden | Utah | 84403-2200 | — |
| Southern Utah Medical Research /ID# 243931 | St. George | Utah | 84790 | — |
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 NCT05393089, 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 Jun 28, 2022 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05393089 live on ClinicalTrials.gov.