Evidence mapPaperPMID 40166690Full record

Trial reportClinical ophthalmology (Auckland, N.Z.)2025

Varenicline Solution Nasal Spray for the Treatment of Dry Eye Disease in Sjogren's Disease: A Pilot Study.

Angela S Gupta, Taylor J Linaburg, Emma Iacobucci, Patrick A Augello, Vivian L Qin, Gui-Shuang Ying, Vatinee Y Bunya, Mina Massaro

Registry-linked trialAbstract readCase ReportsClinical Trial
In one paragraph

Trial report in Clinical ophthalmology (Auckland, N.Z.), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05700422 (A Single-arm Investigator Initiated Study to Evaluate the Efficacy of OC-01), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT05700422 phase4completednot on this map

A Single-arm Investigator Initiated Study to Evaluate the Efficacy of OC-01 (Varenicline Solution) Nasal Spray on Signs and Symptoms of Dry Eye Disease in Subjects With Sjogren's Syndrome

TypeinterventionalSponsorUniversity of PennsylvaniaRan2023 to 2023Enrolled39ConditionsSjogren's Syndrome, Dry EyeArmsVarenicline Nasal Spray
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
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

8 authors.

Angela S Gupta *Department of Ophthalmology, Scheie Eye Institute, University of Pennsylvania, Philadelphia, PA, USA.
Taylor J Linaburg *Department of Ophthalmology, Scheie Eye Institute, University of Pennsylvania, Philadelphia, PA, USA.
Emma IacobucciDepartment of Ophthalmology, Scheie Eye Institute, University of Pennsylvania, Philadelphia, PA, USA.ORCID 0009-0005-5529-4880
Patrick A AugelloDepartment of Ophthalmology, Center for Preventive Ophthalmology and Biostatistics, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.
Vivian L QinDepartment of Ophthalmology, University of California Los Angeles, Los Angeles, CA, USA.
Gui-Shuang YingDepartment of Ophthalmology, Scheie Eye Institute, University of Pennsylvania, Philadelphia, PA, USA.
Vatinee Y BunyaDepartment of Ophthalmology, Scheie Eye Institute, University of Pennsylvania, Philadelphia, PA, USA.
Mina MassaroDepartment of Ophthalmology, Scheie Eye Institute, University of Pennsylvania, Philadelphia, PA, USA.

Funding

P30-CORE GRANT FOR VISION RESEARCHP30EY001583 · UNIVERSITY OF PENNSYLVANIA · 1985 to 2025
$4.4M
NEI NIH HHS P30 EY001583
6 · The paper itself

Abstract

Purpose: We evaluated the efficacy of varenicline solution nasal spray (VNS) in treating dry eye disease (DED) associated with moderate to severe Sjogren's disease and analyzed tear film cytokine levels of patients with DED and Sjogren's disease before and after VNS use. Methods: This was a pilot study involving a single-center, single-arm investigator-initiated trial. Patients with moderate to severe Sjogren's disease were given VNS 0.03 mg twice daily for 28 days. Patients were assessed on day 0 before VNS use, day 14 and day 28. Clinical exam findings, symptomatology as measured by the eye dryness score, and tear cytokines were assessed at baseline and day 28. Results: Thirty-nine subjects were included. Between day 0 and day 28, there was a statistically significant improvement in the eye dryness score (p = 0.01), corneal staining (p < 0.001), and conjunctival staining (p = 0.04). There was a statistically significant increase in tear secretion by unanesthetized Schirmer's in subjects with a baseline Schirmer's ≤5 mm (n = 35 eyes, p = 0.02) and a non-statistically significant increase in tear secretion in subjects with a baseline Schirmer's of 6-10 mm (n = 16 eyes, p = 0.79). There was a statistically significant decrease in tear film cytokine concentration of IFNγ (p = 0.0003), IL-12p70 (p < 0.0001), IL-17a (p = 0.004), IL-1β (p = 0.007), IL-2 (p < 0.0001), IL-4 (p = 0.01), and TNF-α (p = 0.02), and no significant change in IL-6 (p = 0.56) and IL-10 (p = 0.18). Conclusion: Our findings add to existing evidence that VNS improves subjective dry eye symptoms, corneal and conjunctival staining, and tear secretion in a subset of tear-deficient patients, while providing new evidence that VNS reduces concentration of pro-inflammatory cytokines in the tear film. Clinical Trial Registration Number: NCT05700422.

Indexed as

cytokinesdry eye diseaseSjogren’s diseasetear filmvarenicline

Identifiers

PMID40166690
PMCPMC11956706

What Socratic holds

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Registered trials

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 Socratic graph.