Dry eye disease
Conditions
Interventions
experimental group :cyclosporine eye emulsion
control group.:excipient
Sponsors
Eye and ENT Hospital of Fudan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Clinical diagnosis of dry eye, and meet the following conditions: (1) The patients have symptoms such as dryness, photophobia, foreign body sensation, burning sensation, conjunctival congestion et al; (2) Shirmer I test: = 5mm/5min; (3) BUT = 5s; (4) Corneal fluorescein staining is positive; In this study, patients meet the following can be recruited: moderate or more severe degree of foreign body sensation, burning sensation, dryness or photophobia (cumulative score = 6 point), and with any two of (2), (3) and (4) symptoms. 2. All patients give informed consent, and signed informed consent voluntarily; 3. Aged between 18 to 65 years male and female; 4. The eye included with daily life visual acuity of better than 0.1; 5. Willing to comply with the clinical research program; 6. Women of childbearing age should have effective contraception.
Exclusion criteria
Exclusion criteria: 1. Patients who are allergic to any known component of the drug are not included in the study 2. Patients older than 18 or less than 65 are not included in the study; 3. Patients with serious dysfunction of heart, lung, liver and kidney will not be included in the study; 4. Patients with other surface ocular infectious diseases will not be included in the study; 5. Women in pregnancy and lactation are not included in the study; 6. Patients with obstruction of the nasolacrimal duct or patients requiring lacrimal point closure are not included in the study; 7. Patients who are taking or need to use drugs that influence the assessment of the results of this drug are not included in the study; 8. Patients with contact lenses are not included in the study; 9. Patients with eye diseases those can not be cured at the same time are not included in this study, such as eyelid insufficiency, and corneal refractive surgery; 10. Patients who participated in other drug clinical trials within there monthes are not included in the study; 11. Patients who have undergone eye surgery within 3 months are not included in the study, including laser treatment and corneal refractive surgery; 12. Other situations the researchers believe that it is not suitable included in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness;safety; | — |
Countries
China
Contacts
Public ContactXinghuai Sun
Eye and ENT Hospital of Fudan University
Outcome results
None listed