dry eye
Conditions
Interventions
experimental group:Experimental group: 0.05% cyclosporine eye drops (II) and 0.1% sodium hyaluronate eye drops were used
Control group:Control group: 0.1% sodium hyaluronate eye drops
Sponsors
Wuhan Aier Eye Hospital Hankou Hospital
Eligibility
Sex/Gender
All
Age
5 Years to 16 Years
Inclusion criteria
Inclusion criteria: 1. Subjects must meet all of the following criteria for enrolment:5~16 years old, gender is not limited;Parents or children have one of the subjective symptoms such as dryness sensation, foreign body sensation, burning sensation, fatigue sensation, discomfort sensation, fluctuating vision, frequent blinking, etc. and meet the 2020 Dry Eye Expert Consensus grading criteria for moderate-to-severe dry eye: Moderate: the rang of the corneal lesion by slit lamp microscopy: no more than 2 quadrants and/or corneal fluorescein staining points =5 and < 30, BUT in 2s or more. Corneal fluorescein staining spots fused into thick spots, flakes or accompanied by filaments. 2. Including but not limited to dry eye caused by the following diseases: meibomian gland dysfunction; systemic immune diseases (stable phase); 3 months after eye surgery; allergic conjunctivitis (non-attack phase); 3. With the consent of the parents, they voluntarily participated in this study and signed a written informed consent form.
Exclusion criteria
Exclusion criteria: Subjects cannot be enrolled if they meet any of the following criteria: 1. Suffering from uncontrolled active eye diseases that may affect the reliability of the observation of this clinical trial, such as combined infectious eye diseases (viruses, bacteria, fungi, protozoa), uveitis, nasolacrimal duct obstruction, intraocular infection, etc.; 2. History of ocular herpes; 3. Patients with exophthalmos and incomplete eyelid closure; 4. Ocular surface diseases such as thermal burns or chemical injuries caused by abnormal limbal stem cells or other causes; 5. Patients wearing contact lenses during the study period; 6. Patients with uncontrolled systemic diseases or other reasons who are judged by the researcher to be unsuitable for entry into this study; 7. Severe heart, lung, Liver and renal dysfunction; 8. Psychotic patients; 9.Patients with active ocular infections who have a history of allergy to the drugs scheduled for use in the study or to any of the components tested (eg, cyclosporine, fluorescein, etc.); 10. Use of dry eye-related therapeutic drugs (artificial tears, immunosuppressants, glucocorticoids, etc.) 2 weeks before enrollment; 11. Drugs whose systemic application may affect the evaluation of the results of this test (immunosuppressants, glucocorticoids, etc.); 12. Drugs that need to be applied locally that may affect the evaluation of the results of this test (such as immunosuppressants, intraocular pressure lowering drugs, non-steroidal anti-inflammatory drugs, anticholinergics, etc.); 13. Patients who have participated or are participating in other clinical trials within 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BUT;Corneal fluorescence staining score; | — |
Secondary
| Measure | Time frame |
|---|---|
| red eye index;Tear height;Meibomian gland inflammatory cells;Meibomian gland function;Best corrected visual acuity;optometry;IOP; | — |
Countries
China
Contacts
Public ContactZeng Qingyan
Wuhan Aier Eye Hospital Hankou Hospital
Outcome results
None listed