dry eye
Conditions
Interventions
Tear Stimulation Group 1:Tear Stimulation
Fake Tear Stimulation Group:Fake Tear Stimulation
Tear Stimulation Group 2:Tear Stimulation
Artificial Tear Group:Artificial tear
Sponsors
Eye & ENT Hospital of Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years; 2. Sign the written informed consent; 3. The patient complained of dry eyes in both eyes; 4. The patient has not received any dry eye treatment at present (within 30 days before screening); Or currently using OTC artificial tear, eye moisturizer gel and other products (within 30 days before screening); 5. Schirmer test: 1-10mm (including 1mm and 10mm); 6. Be able and willing to participate in all test evaluations and visits as instructed; 7. (This item is only included in the second part) After the single nerve stimulation treatment, Schirmer tear increases >= 10mm.
Exclusion criteria
Exclusion criteria: 1. Sjogren's syndrome or other autoimmune diseases; 2. Dry eye treatment is being performed (within 30 days prior to screening) unless prescribed artificial tears, eye moisturizing gel, including prescription eye drops (cyclosporine eye drops, diquafosone sodium eye drops, steroid eye drops, etc.), meibomian gland physical therapy (meibomian gland massage, intense pulse light, etc.); 3. Patients who have received permanent lacrimal duct embolization, or patients who have received degradable lacrimal plug within half a year; 4. Facial nerve disease, neuromuscular disease, etc.; 5. Nose skin infection, trauma, ulcer, etc.; 6. History of eye surgery within 6 months before screening; 7. Active diseases of the anterior segment (such as keratoconjunctival infection and keratitis), malignant tumors around the eye and glaucoma; 8. Abnormal eyelid anatomy (such as eyelid insufficiency, entropion or ectropion) or abnormal blinking; 9. Dry eye disease secondary to scar formation, such as alkali burn, cicatricial pemphigus, destruction of conjunctival goblet cells, etc; 10. Weared contact lenses within 90 days before screening, or expected to use contact lenses during the test; 11. Used any eye drops, eye moistening gel or eyelid margin cleaning within 2 hours before screening; 12. Patients who are pregnant, nursing or planning to become pregnant; 13. Uncontrolled systemic diseases; 14. Currently no undergoing clinical trials; 15. Have used any drug (such as antihistamines or antidepressants) that is known to cause eye dryness within 30 days before screening, or oral drugs which is expected to cause eye dryness during the test; 16. Any circumstances in which the investigator deems it inappropriate to participate in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| schirmer test; | — |
Secondary
| Measure | Time frame |
|---|---|
| tear break-up time;ocular surface disease index;corneal fluorescence staining;Ligamine green staining of conjunctiva;tear meniscus height;meibomian gland secretion score;conjunctival impression cytology; | — |
Countries
China
Contacts
Public ContactGong Lan
Eye, Ear, Nose, and Throat Hospital of Fudan University
Outcome results
None listed