The efficacy and safety of varenicline nasal spray for the management of dry eye signs: a systematic review and meta-analysis

source extracted confidence: high 2026-04-09
#humans #nasal-sprays #varenicline #dry-eye-syndromes

The efficacy and safety of varenicline nasal spray for the management of dry eye signs: a systematic review and meta-analysis

Bashrahil et al., 2023 | BMC Ophthalmol | Meta Analysis

Citation

Bashrahil Bader, Taher Nada, ... Alghamdi Saeed. The efficacy and safety of varenicline nasal spray for the management of dry eye signs: a systematic review and meta-analysis. BMC Ophthalmol. 2023-Jul-14;23(1):319. doi:10.1186/s12886-023-03069-y

Abstract

BACKGROUND: Dry eye disease (DED) is caused by a persistently unstable tear film leading to ocular discomfort and is treated mainly with tear supplementation. There is emerging evidence that nicotinic acetylcholine receptor (nAChR) agonists (e.g., varenicline and simpinicline) nasal sprays are effective for DED. Our systematic review and meta-analysis assessed the efficacy and safety of varenicline nasal spray (VNS) for DED treatment. METHODS: The Medline, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) databases were searched. Only randomized controlled trials (RCTs) that evaluated the efficacy of VNS versus placebo were included. The efficacy endpoint was the mean change in the anesthetized Schirmer test score (STS), a measure of basal tear production, from baseline. The safety endpoints were serious adverse events (SAEs) and adverse events (AEs). The standardized mean difference (SMD) was used for continuous outcomes, while the risk ratio (RR) was used to demonstrate dichotomous variables. The certainty of the evidence was rated utilizing the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. The risk of bias assessment was conducted using the Revised Cochrane risk of bias tool for randomized trials. RESULTS: Three RCTs (n = 1063) met the eligibility criteria. All RCTs had a low risk of bias. The meta-analysis found a statistically significant increase in the mean STS change from baseline on day 28. The pooled analysis found no significant difference between VNS and placebo in the frequency of SAEs and ocular AEs. However, VNS had a significant effect on developing nasal cavity-related AEs. CONCLUSION: VNS caused a highly significant improvement regarding the efficacy endpoint but caused an increased frequency of some nasal cavity-related AEs (i.e., cough and throat irritation). However, it caused neither SAEs nor ocular AEs. Included studies had a low risk of bias.

Key Findings

Three RCTs (n = 1063) met the eligibility criteria. All RCTs had a low risk of bias. The meta-analysis found a statistically significant increase in the mean STS change from baseline on day 28. The pooled analysis found no significant difference between VNS and placebo in the frequency of SAEs and ocular AEs. However, VNS had a significant effect on developing nasal cavity-related AEs.

Outcomes Measured

  • Requires manual extraction

Population

Field Value
Population See abstract
Sample Size 1063
Age Range See abstract
Condition See abstract

MeSH Terms

  • Humans
  • Nasal Sprays
  • Varenicline
  • Dry Eye Syndromes

Evidence Classification

  • Level: Meta Analysis
  • Publication Types: Meta-Analysis, Systematic Review, Journal Article
  • Vertical: niacin

Provenance

Source extracted via PubMed E-utilities API on 2026-04-09