An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-1)

Phase 3 Completed 309 enrolled Orasis Pharmaceuticals Ltd.

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2020-10-18
Primary completion: 2022-02-11
Completion: 2022-02-19

Outcome

Met primary endpoint

registry analysis (superiority test); CSF-1 vs Vehicle; p <0.01; Odds Ratio (OR) 2.916 (95% CI 1.663 to 5.113); Regression, Logistic NCT04599933 ↗

paper CSF-1 met the primary and key secondary endpoints. PMID 38216351 ↗

Publications

Holland E, Karpecki P, Fingeret M, Schaeffer J, Gupta P, Fram N, Smits G, Ignacio T, Lindstrom R. Efficacy and Safety of CSF-1 (0.4% Pilocarpine Hydrochloride) in Presbyopia: Pooled Results of the NEAR Phase 3 Randomized, Clinical Trials. Clin Ther. 2024 Feb;46(2):104-113. doi: 10.1016/j.clinthera.2023.12.005. Epub 2024 Jan 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CSF-1	Unknown	0.4 %	Topical