An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-2)

Phase 3 Completed 304 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: 2020-10-26
Primary completion: 2022-01-21
Completion: 2022-01-28

Outcome

Met primary endpoint

registry analysis (superiority test); CSF-1 vs Vehicle; p <0.01; Odds Ratio (OR) 2.979 (95% CI 1.753 to 5.064); Regression, Logistic NCT04599972 ↗

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 %	Other