Trial reportTranslational vision science & technology2020
Novel Extranasal Tear Stimulation: Pivotal Study Results.
Trial report in Translational vision science & technology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06525961 (A Single-center, Open-label, Single-arm Study to Evaluate the Effectiveness and Safety of Extra Nasal Neurostimulator in Patients With Dry Eye Disease Dissatisfied With Artificial Tears), which is not on this map. Cited by 19 papers, 1 of them a synthesis that pooled 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.
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.
A Single-center, Open-label, Single-arm Study to Evaluate the Effectiveness and Safety of Extra Nasal Neurostimulator in Patients With Dry Eye Disease Dissatisfied With Artificial Tears
Who cites it
19 citing papers in PubMed, 1 synthesis or guideline pooled it, 33 citations in OpenAlex.
- Aqueous-deficient dry eye disease: Preferred practice pattern guidelines on clinical approach, diagnosis, and management.Indian journal of ophthalmology · 2023Guideline
- Model of ocular surface ion and water transport predicts efficacy of dry eye therapeutics.The Journal of general physiology · 2026Article
- AstroOphthalmology: ocular anterior segment.NPJ microgravity · 2026Review
- Redefining Dry Eye Disease Management: Emerging Pharmacologic and Device-Based Therapies in the Era of Precision Care: A Narrative Review.Ophthalmology and therapy · 2026Review
- Advances in Pharmacotherapy and Physiotherapy for Dry Eye Disease: Molecular Mechanisms and Future Directions-A Narrative Literature Review.International journal of molecular sciences · 2026Review
- Current Diagnosis and Management of Ocular Graft-Versus-Host Disease at a Tertiary Cancer Center.Journal of clinical medicine · 2026Review
- Focused Narrative Review: Non-Pharmacological, Noninvasive Neurostimulation or Neuromodulation Treatment of Ocular Neuropathic Pain.Clinical ophthalmology (Auckland, N.Z.) · 2026Review
- Electrotherapy in the management of neuropathic corneal pain: narrative review.Experimental biology and medicine (Maywood, N.J.) · 2026Review
- Cyclic extranasal neurostimulation for dry eye disease: a 4-week stimulation and 6-week intermission regimen based on neural adaptation dynamics.Eye and vision (London, England) · 2025Article
- Navigating the Dry Eye Therapeutic Puzzle: A Mechanism-Based Overview of Current Treatments.Pharmaceuticals (Basel, Switzerland) · 2025Review
- On the nose: nasal neurostimulation as a technology countermeasure for sinonasal congestion in astronauts.Frontiers in physiology · 2025Article
- Tolerability of Current Treatments for Dry Eye Disease: A Review of Approved and Investigational Therapies.Clinical ophthalmology (Auckland, N.Z.) · 2024Review
- Dry eye disease: identification and therapeutic strategies for primary care clinicians and clinical specialists.Annals of medicine · 2023Review
- Dry eye disease in astronauts: a narrative review.Frontiers in physiology · 2023Review
- Dry eye syndrome: comprehensive etiologies and recent clinical trials.International ophthalmology · 2022Review
- Matching-adjusted indirect comparison of phase 3 clinical trial outcomes: OC-01 (varenicline solution) nasal spray and cyclosporine a 0.05% ophthalmic emulsion for the treatment of dry eye disease.Journal of managed care & specialty pharmacy · 2022Review
- Personalized Management of Dry Eye Disease: Beyond Artificial Tears.Clinical ophthalmology (Auckland, N.Z.) · 2022Review
- Alternative therapies for dry eye disease.Current opinion in ophthalmology · 2021Review
- Stimulating Tear Production: Spotlight on Neurostimulation.Clinical ophthalmology (Auckland, N.Z.) · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 6 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Purpose: To evaluate the efficacy and safety of iTEAR, a novel, portable, sonic external neuromodulation device, for the treatment of dry eye disease (DED). Methods: This was a multicenter, open-label, single-arm clinical trial that included adult patients with DED with a Schirmer score of ≤10 mm in at least one eye. Enrolled subjects were instructed to apply the study device at least twice per day for 30 seconds bilaterally to the external nasal nerve. After the initial baseline visit, patients were followed up at days 3, 14, 30, 90, and 180. The primary efficacy endpoint was the Schirmer index (change from unstimulated to stimulated tear production as measured by the Schirmer test) at day 30. The major secondary endpoint was the change in symptoms of DED at day 30 evaluated using the Ocular Surface Disease Index (OSDI). Results: A total of 101 subjects evaluated at day 30 had a mean Schirmer index of 9.4 mm (95% confidence interval [CI], 7.4-11.3), and the baseline OSDI improved by an average of 14.4 (95% CI, 11.1-17.7). Both endpoints were highly statistically and clinically significant at all time points. There were two mild unanticipated adverse events definitely related to the device. Conclusions: The safety and efficacy of the iTEAR device observed in this study support its indication for treating DED. Translational Relevance: Neurostimulation has the potential to improve signs and symptoms of DED.
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What OpenQuestion holds
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 OpenQuestion graph.