Dry eye
Conditions
Interventions
experimental group:Drug: 3% diquafosol ophthalmic solution + azelastine hyfrochloride eye drops.
Sponsors
Ophthalmic Center of the Second Affiliated Hospital of Medical College of Zhejiang University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed as allergic conjunctivitis related dry eye; 2. The diagnosis of allergic conjunctivitis is based on symptoms (itching, red eyes, tears, edema), conjunctival papilla hyperplasia and disease history; The diagnostic criteria of dry eye were as follows (1) Dry eye can be diagnosed by one of the subjective symptoms such as dryness, foreign body sensation, burning sensation, fatigue, discomfort and vision fluctuation, but <= 5 s or Schirmer I test (without surface anesthesia) <= 5 cm / 5 min; (2) Dry eye can be diagnosed by one of the subjective symptoms such as dryness, foreign body sensation, burning sensation, fatigue, discomfort, visual acuity fluctuation and 5 s < but <= 10 s or 5 mm / 5 min < Schirmer I test results (without surface anesthesia) <= 10 cm / 5 min, and positive corneal fluorescein staining can be used to diagnose dry eye.
Exclusion criteria
Exclusion criteria: 1. Objects allergic to the test drug; 2. Women in pregnancy and lactation or those who have family planning recently; 3. Patients who are suspected to be in active phase of fungal, bacterial or viral keratitis or conjunctivitis; 4. Patients with other obvious conjunctival, corneal and iris lesions; 5. Patients with but 0 s or s i t < 2 mm / 5 min; 6. Patients with more than 30 staining points of fluorescein sodium in the whole cornea, with patchy color fusion or filaments; 7. Patients with severe meibomian gland dysfunction (grade 4); 8. Patients with severe primary diseases such as heart, cerebrovascular, liver, kidney and hematopoietic system; 9. Patients with intraocular surgery or ocular trauma in the past 6 months; 10. The patients who received the treatment of lacrimal dots embolization in the past one month; 11. Patients with history of single cell virus corneal infection; 12. Patients who could not stop wearing contact lenses during the trial; 13. Patients whose systemic or ocular long-term medication may affect the study evaluation; 14. The subjects who could not guarantee the medication and follow-up as required during the trial; 15. Patients with Sjogren's syndrome, systemic diseases and other eye diseases that affect the evaluation of therapeutic effect; 16. The researcher thinks that there are other subjects that are not suitable for the test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| changes of tear film breakup time in 4 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes of corneal fluorescein staining in 2 and 4 weeks;Changes of ocular symptom scores in 2 and 4 weeks;Changes of OSDI scores in 2 and 4 weeks;Changes of lissamine conjunctival staining scores in 2 and 4 weeks;Changes of Schirmer test scores in 2 and4 weeks; | — |
Countries
China
Contacts
Public ContactXiuming Jin
Ophthalmic Center of the Second Affiliated Hospital of Medical College of Zhejiang University
Outcome results
None listed