Trials / Completed
CompletedNCT03804268
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
- 323 (actual)
- Sponsor
- Allergan · Industry
- Sex
- All
- Age
- 40 Years – 55 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Vehicle | Vehicle, one drop in each eye, once daily, for up to 30 days. |
| DRUG | Pilocarpine HCl Ophthalmic Solution | Pilocarpine HCl ophthalmic solution 1.25%, one drop in each eye, once daily, for up to 30 days. |
Timeline
- Start date
- 2018-12-21
- Primary completion
- 2019-10-31
- Completion
- 2019-10-31
- First posted
- 2019-01-15
- Last updated
- 2021-12-28
- Results posted
- 2021-12-28
Locations
36 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03804268. Inclusion in this directory is not an endorsement.