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NCT03804268 · ClinicalTrials.gov registry record · Phase 3
Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With Presbyopia
A Phase 3 study, sponsored by Allergan.
- Completed
- Registry status
- Phase 3
- Development phase
- 323
- Enrollment target
NCT03804268: Completed Phase 3 study, sponsored by Allergan.
NCT03804268 is a Phase 3 study that has completed, run by Allergan. The registered enrollment target is 323 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03804268, a Phase 3 study, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 323 participants
- Enrollment target
Study Summary
A study to evaluate the efficacy, safety, and pharmacokinetics of pilocarpine hydrochloride (HCl) ophthalmic solution (AGN-190584) when administered bilaterally, once daily for 30 days in participants with presbyopia.
Primary Outcome
Visual acuity for near (40 centimeters (cm)) target was measured in mesopic conditions using an eye chart. Mesopic condition was defined as low lighting 3.2 to 3.5 candelas per square meter (cd/m\^2) measured at the target. Percentage of participants with 3 lines or more improvement from Baseline in mesopic, high-contrast DCNVA are reported.
Interventions
- OTHER Vehicle
- DRUG Pilocarpine HCl Ophthalmic Solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 323 participants |
| Start Date | 2018-12-21 |
| Est. Completion | 2019-10-31 |
| Phase | Phase 3 |
What the finished NCT03804268 record still lists
NCT03804268 is an interventional study that assigns participants to a tested intervention. The registered 323 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 2 interventions - of which Vehicle is the first listed.
NCT03804268 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03804268 about?
NCT03804268 is a clinical study titled "Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With Presbyopia". A study to evaluate the efficacy, safety, and pharmacokinetics of pilocarpine hydrochloride (HCl) ophthalmic solution (AGN-190584) when administered bilaterally, once daily for 30 days in participants with presbyopia.
What is the current status of trial NCT03804268?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 323 participants. The study started on 2018-12-21. Estimated completion is 2019-10-31.
What interventions are being tested in trial NCT03804268?
The interventions under investigation include: Vehicle (OTHER), Pilocarpine HCl Ophthalmic Solution (DRUG).
Who is sponsoring clinical trial NCT03804268?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03804268's enrollment target sits among peer trials
323 1081st of 2000 higher than 920 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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