Efficacy and safety of varenicline nasal spray in dry eye disease: a systematic review and meta-analysis of randomized controlled trials
Abstract
Background: Dry eye disease is a multifactorial ocular surface disorder characterized by tear film instability and inflammation, leading to impaired visual function and reduced quality of life. Varenicline solution nasal spray is a nicotinic acetylcholine receptor agonist stimulates the trigeminal pathway to enhance basal tear production.
Methods: We searched electronic databases (PubMed, Scopus, and Web of Science) from inception to February 2026 to identify randomized controlled trials (RCTs) assessing varenicline nasal spray (0.03 mg or 0.06 mg twice daily) in adults with dry eye symptoms. Primary outcomes included the proportion of patients achieving ≥ 10-mm improvement in Schirmer test score (STS) and mean change in STS. Secondary outcomes included Eye Dryness Score (EDS), corneal fluorescein staining and treatment-emergent adverse events (TEAEs). Meta-analyses were conducted using random-effects models. The primary analysis focused on the approved 0.06 mg dose, with dose-based subgroup analyses comparing 0.03 mg and 0.06 mg doses where data were available.
Results: Seven randomized controlled trials were included. In the primary 0.06 mg analysis, varenicline nasal spray significantly improved mean Schirmer test score change (MD = 5.52 mm; 95% CI: 4.08 to 6.97; p < 0.0001) and increased the proportion of patients achieving a ≥ 10-mm Schirmer test score improvement (RR = 1.86; 95% CI: 1.50 to 2.30; p < 0.0001). Eye Dryness Score showed a non-significant numerical…
How strong is the evidence?
Evidence Hub reads this as a meta-analysis, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid.
Read the paper
Related studies
- The Matrisome: In Silico Definition and In Vivo Characterization by Proteomics of Normal and Tumor Extracellular Matrices
- The Escherichia coli MG1655 in silico metabolic genotype: Its definition, characteristics, and capabilities
- In silico pharmacology for drug discovery: methods for virtual ligand screening and profiling
- In silico prediction of splice-altering single nucleotide variants in the human genome
- In silico clinical trials: how computer simulation will transform the biomedical industry
- In silico optimization of a guava antimicrobial peptide enables combinatorial exploration for peptide design
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.