Trials / Completed
CompletedNCT04599933
An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-1)
A Multi-Center, Double-Masked, Vehicle-Controlled, Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (the NEAR-1 Study: Near Eye-vision Acuity Restoration)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 309 (actual)
- Sponsor
- Orasis Pharmaceuticals Ltd. · Industry
- Sex
- All
- Age
- 45 Years – 64 Years
- Healthy volunteers
- Not accepted
Summary
This is a 4-visit, multi-center, randomized, double-masked, vehicle-controlled study evaluating the safety and efficacy of CSF-1 in the temporary correction of presbyopia.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CSF-1 | One drop bilaterally twice daily for approximately 2 weeks. |
| DRUG | Vehicle | One drop bilaterally twice daily for approximately 2 weeks. |
Timeline
- Start date
- 2020-10-18
- Primary completion
- 2022-02-11
- Completion
- 2022-02-19
- First posted
- 2020-10-23
- Last updated
- 2024-04-04
- Results posted
- 2023-11-28
Locations
17 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04599933. Inclusion in this directory is not an endorsement.