Trials / Completed
CompletedNCT04657172
Safety & Efficacy of Pilocarpine Eye Solutions for Temporary Improvement of Near Vision in Presbyopic Adults
A Phase 3 Study of the Safety and Efficacy of 1% and 2% Pilocarpine Ophthalmic Solutions Administered With the Optejet® Microdose Dispenser for Temporary Improvement of Near Vision in Adults With Presbyopia
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 84 (actual)
- Sponsor
- Eyenovia Inc. · Industry
- Sex
- All
- Age
- 40 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
Volunteer participants are evaluated for eligibility during a Screening Visit; those meeting study inclusion/exclusion criteria are scheduled for 3 treatment visits. At each treatment visit, 1 of the 3 study solutions is self-administered to both eyes. Afterwards, efficacy and safety assessments are performed over a 3-hour period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pilocarpine Ophthalmic | Pilocarpine 1% or 2% ophthalmic solution administered with the Optejet microdose dispenser |
| DRUG | Placebo | Vehicle ophthalmic solution administered with the Optejet microdose dispenser |
Timeline
- Start date
- 2020-12-15
- Primary completion
- 2021-03-26
- Completion
- 2021-03-26
- First posted
- 2020-12-08
- Last updated
- 2021-08-09
Locations
9 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04657172. Inclusion in this directory is not an endorsement.