Evidence map›Paper›PMID 42481782›Full record

SynthesisInternational ophthalmology2026

Efficacy and safety of varenicline nasal spray in dry eye disease: a systematic review and meta-analysis of randomized controlled trials.

Sara Almutawtah, Yaqoub AlFoudari, Ahmed Mohammad, Shahad T Ahmad, Shooq Hussain Alanezi, Farah R Alqussair, Abdulrahman Alfailakawi, Haidar Bonajmah, Abdullah M Alharran

Abstract readSystematic ReviewMeta-Analysis
PubMed Publisher
In one paragraph

Synthesis in International ophthalmology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Sara AlmutawtahKuwait Institute for Medical Specialization, Kuwait City, Al Asimah, Kuwait.
Yaqoub AlFoudariKuwait Institute for Medical Specialization, Kuwait City, Al Asimah, Kuwait.
Ahmed MohammadKuwait Institute for Medical Specialization, Kuwait City, Al Asimah, Kuwait.
Shahad T AhmadKuwait Institute for Medical Specialization, Kuwait City, Al Asimah, Kuwait.
Shooq Hussain AlaneziKuwait Institute for Medical Specialization, Kuwait City, Al Asimah, Kuwait.
Farah R AlqussairCollege of Medicine and Medical Sciences, Arabian Gulf University, Manama, Kingdom of Bahrain.
Abdulrahman AlfailakawiRoyal College of Surgeons in Ireland, Dublin, Ireland.
Haidar BonajmahKuwait Institute for Medical Specialization, Kuwait City, Al Asimah, Kuwait.
Abdullah M AlharranCollege of Medicine and Medical Sciences, Arabian Gulf University, Manama, Kingdom of Bahrain. Dr_alharran@outlook.com.ORCID https://orcid.org/0009-0003-2337-6588

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDry 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.

methodsWe 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.

resultsSeven 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 improvement (MD =  - 4.38; 95% CI: - 12.02 to 3.25; p = 0.2601). Dose-based subgroup analyses showed consistent Schirmer test benefits for both 0.03 mg and 0.06 mg doses. Corneal fluorescein staining was not significantly improved. Ocular adverse events and reduced visual acuity were comparable between groups, while non-ocular adverse events, particularly sneezing, were more frequent with varenicline.

conclusionsVarenicline nasal spray improved tear production, with less consistent effects on symptoms and corneal staining. Ocular safety was comparable, but sneezing was more frequent.

Indexed as

Dry Eye SyndromesRandomized Controlled Trials as TopicVareniclineHumansNasal SpraysNicotinic AgonistsTearsTreatment OutcomeNasal SpraysNicotinic AgonistsVareniclineDry eye diseaseNasal spraySchirmer testTear productionVarenicline

Identifiers

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.