Trials / Completed
CompletedNCT03857542
A Phase 3 Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With Presbyopia
A Phase 3, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of AGN-190584 in Participants With Presbyopia
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 427 (actual)
- Sponsor
- Allergan · Industry
- Sex
- All
- Age
- 40 Years – 55 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pilocarpine HCl Ophthalmic Solution | Pilocarpine HCl ophthalmic solution 1.25%, one drop in each eye, once daily, for up to 30 days. |
| OTHER | Vehicle | Vehicle, one drop in each eye, once daily, for up to 30 days. |
Timeline
- Start date
- 2019-03-01
- Primary completion
- 2020-09-10
- Completion
- 2020-09-10
- First posted
- 2019-02-28
- Last updated
- 2021-12-29
- Results posted
- 2021-12-29
Locations
35 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03857542. Inclusion in this directory is not an endorsement.