A Multi-Center, Double-Masked Evaluation of the Efficacy and Safety of CSF-1 in the Treatment of Presbyopia
Summary
This is a 4-visit, multi-center, randomized, double-masked, parallel group study evaluating the safety and efficacy of CSF-1 in the treatment of presbyopia.
Timeline
- Start
- 2019-02-26
- Primary completion
- 2019-07-11
- Completion
- 2019-07-26
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
registry analysis (superiority test); CSF-1-FDC vs Diclo; p = 0.8445; Odds Ratio (OR) 1.103 (95% CI 0.413 to 2.949); Regression, Logistic reads as mixed primary results NCT03885011 ↗
registry analysis (superiority test); CSF-1-FDC vs Diclo; p = 0.0015; Odds Ratio (OR) 3.664 (95% CI 1.646 to 8.154); Regression, Logistic reads as mixed primary results NCT03885011 ↗
release “The Phase 2b trial results showed that CSF-1 (pilocarpine hydrochloride 0.4%) preservative-free ophthalmic solution formulated in a proprietary vehicle met its primary endpoint” reads as met primary endpoint orasis-pharma.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CSF-1 | Unknown | — | Other |
| Comparator | CSF-1 Component #1 | Unknown | — | Other |
| Comparator | CSF-1 Component #2 | Unknown | — | Other |