Varenicline solution nasal spray for dry eye disease in Chinese patients: a randomized phase 3 trial.

ABSTRACT:

Background

Dry eye disease has a high prevalence and exerts a significant negative effect on quality of life. In China, there are currently no available nasal sprays to promote natural tear production in patients with dry eye disease. We therefore evaluated the efficacy and safety of OC-01 (varenicline solution) nasal spray versus vehicle in Chinese patients with dry eye disease.

Methods

This was a randomized, multicenter, double-masked, vehicle-controlled, phase 3 clinical trial conducted at ophthalmology departments in 20 hospitals across China (NCT05378945). Eligible patients had a diagnosis of dry eye disease based on patient symptoms, Eye Dryness Score (EDS), Schirmer's Test (with topical anesthesia) Score (STS), and corneal fluorescein staining (CFS) score. Participant

SUBMITTER: Tian L 

PROVIDER: S-EPMC10909742 | biostudies-literature | 2024 Apr

REPOSITORIES: biostudies-literature