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NCT03857542 · ClinicalTrials.gov registry record · Phase 3
A 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
- 427
- Enrollment target
NCT03857542: Completed Phase 3 study, sponsored by Allergan.
NCT03857542 is a Phase 3 study that has completed, run by Allergan. The registered enrollment target is 427 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03857542, a Phase 3 study, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 427 participants
- Enrollment target
Study Summary
This clinical study will evaluate pilocarpine hydrogen chloride (HCl) ophthalmic solution (AGN-190584) in an expanded participant population to establish efficacy, safety, and tolerability versus the vehicle-control when administered, over a 30-day study intervention period, once daily bilaterally in participants with presbyopia.
Primary Outcome
Visual acuity for near (40 centimeter (cm)) and distance (4 meter (m)) targets were measured in mesopic conditions using an eye chart. High contrast corrected distance visual acuity (CDVA) was assessed binocularly (in each eye) using the provided visual acuity charts for distance vision in a room with mesopic lighting conditions measured at the target. Forced choice letter by-letter scoring was used for each test and the total number of correct letters or the highest value (number) of the grid i
Interventions
- OTHER Vehicle
- DRUG Pilocarpine HCl Ophthalmic Solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 427 participants |
| Start Date | 2019-03-01 |
| Est. Completion | 2020-09-10 |
| Phase | Phase 3 |
What the finished NCT03857542 record still lists
NCT03857542 is an interventional study that assigns participants to a tested intervention. The registered 427 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 (45% lower).
The record links to 0 conditions, and to 2 interventions - of which Vehicle is the first listed.
NCT03857542 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03857542 about?
NCT03857542 is a clinical study titled "A Phase 3 Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With Presbyopia". This clinical study will evaluate pilocarpine hydrogen chloride (HCl) ophthalmic solution (AGN-190584) in an expanded participant population to establish efficacy, safety, and tolerability versus the vehicle-control when administered, over a 30-day study intervention period, once daily bilaterally i...
What is the current status of trial NCT03857542?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 427 participants. The study started on 2019-03-01. Estimated completion is 2020-09-10.
What interventions are being tested in trial NCT03857542?
The interventions under investigation include: Vehicle (OTHER), Pilocarpine HCl Ophthalmic Solution (DRUG).
Who is sponsoring clinical trial NCT03857542?
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 NCT03857542's enrollment target sits among peer trials
427 880th of 2000 higher than 1,119 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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