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Effect of an Extranasal Neurostimulation Device on Dry Eye Disease and Tear Biomarkers in a Chinese Cohort?

Effect of an Extranasal Neurostimulation Device on Dry Eye Disease and Tear Biomarkers in a Chinese Cohort?

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116289
Enrollment
Unknown
Registered
2026-01-07
Start date
2025-04-02
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry eye syndrome

Interventions

Experimental Group:All patients were treated with iTEAR for 4 weeks, twice a day, with an interval of no less than 6 hours between each dose, and each dose lasted for 30 seconds on each side

Sponsors

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Tongji Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosed with DED according to the TFOS DEWS II diagnostic methodology report and the Chinese Dry Eye Expert Consensus (2024). 2. Aged between 18 and 75 years old. 3. SIT result > 5 mm/5 min. 4. No DED-related ocular surface physiotherapy within 30 days prior to screening, or discontinuation of over-the-counter artificial tears and ocular gels for at least 30 days. 5. Willingness and ability to complete all trial visits and assessments.

Exclusion criteria

Exclusion criteria: 1. Pregnancy or lactation. 2. Intraocular surgery within 6 months prior to enrollment. 3. Clinically significant corneal or conjunctival scarring. 4. Hypersensitivity to nasal nerve stimulation (e.g., status post nasal surgery, active allergic rhinitis). 5. Active skin lesions in the nasal area. 6. Ocular malignancies or uncontrolled glaucoma. 7. Eyelid abnormalities (e.g., lagophthalmos, entropion, ectropion). 8 .Facial neuromuscular disorders. 9. History of punctal plug insertion. 10.Any other conditions deemed unsuitable by the principal investigator.

Design outcomes

Primary

MeasureTime frame
Ocular Surface Disease Index (OSDI) score;Fluorescein Tear Break-Up Time (FBUT);Corneal Fluorescein Staining (CFS) score;Schirmer I Test (SIT) value;

Secondary

MeasureTime frame
Tear Interleukin-6 (IL-6) concentration;Tear Matrix Metalloproteinase-9 (MMP-9) concentration;

Countries

China

Contacts

Public ContactLi Guigang

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Tongji Hospital

guigangli@hust.edu.cn+86 139 8604 6874

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026