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NCT04983589 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by Allergan.
- Completed
- Registry status
- Phase 3
- Development phase
- 230
- Enrollment target
NCT04983589 is a Phase 3 study that has completed, run by Allergan. The registered enrollment target is 230 participants.
The verdict
NCT04983589, a Phase 3 study, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 230 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Vehicle
- DRUG Pilocarpine HCl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 230 participants |
| Start Date | 2021-09-02 |
| Est. Completion | 2022-02-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04983589
The ClinicalTrials.gov registry entry for NCT04983589 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 230 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Allergan, which has 314 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Vehicle is the first listed.
NCT04983589 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04983589 about?
NCT04983589 is a clinical study titled "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". 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 (p...
What is the current status of trial NCT04983589?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 230 participants. The study started on 2021-09-02. Estimated completion is 2022-02-11.
What interventions are being tested in trial NCT04983589?
The interventions under investigation include: Vehicle (DRUG), Pilocarpine HCl (DRUG).
Who is sponsoring clinical trial NCT04983589?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
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