dry eye
Conditions
Interventions
Experimental group:Extranasal nerve stimulation
Sponsors
Wuhan Aier Hankou Eye Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria at the time of screening: • Age = 18 years; • Meet the diagnostic criteria of the Chinese dry eye expert consensus (2020): the main complaint is one of the subjective symptoms such as eye dryness, foreign body sensation, burning sensation, fatigue, discomfort, red eyes, and vision fluctuations, and the time of rupture of the tear film stained with fluorescein (FBUT) = 5s; • The patient has not received dry eye-related treatment within 30 days before screening; or is using over-the-counter artificial tears, eye lotion gel, etc. within 30 days before screening; • Sign a written informed consent form; • Able and willing to participate in all trial evaluations and visits as directed
Exclusion criteria
Exclusion criteria: Subjects who had any of the following at the time of screening were ineligible for inclusion in this study: • Women who are pregnant, breastfeeding, or planning to become pregnant. • Patients with Sjogren's syndrome or other rheumatic diseases; • Patients with a history of eyelid dysfunction or facial nerve palsy; • Patients with a history of neuromuscular disease; • Patients with a history of uncontrolled eye or systemic disease; • Patients with clinically significant localized skin diseases (e.g. infections) at the treatment site; • A history of eye surgery within 6 months prior to screening; • Patients with acute infectious or non-infectious eye disease in any anterior or posterior segment at any time within 30 days prior to use; • Presence of clinically significant keratoconjunctival scar-damaging ocular surface disease • Patients with high sensitivity to nasal nerve stimulation (e.g. after nasal surgery, including but not limited to: rhinoplasty, rhinoplasty, nasal/intranasal/nasal surgery, etc.; gasteminal neuralgia after herpes virus infection; allergic rhinitis, etc.) • Any circumstances in which the investigator deems it inappropriate to participate in the clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| River of tears height; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rupture time of fluorescein stained tear film;Keratoconjunctiva staining score;lipid layer thickness;tear fern test; | — |
Countries
China
Contacts
Public ContactZeng Qingyan
Wuhan Aier Hankou Eye Hospital
Outcome results
None listed