Allergic Conjunctivitis-Associated Dry Eye in Children
Conditions
Interventions
experimental group:Sodium Hyaluronate Eye Drops and Olopatadine Hydrochloride Eye Drops and 0.05% Cyclosporine Eye Drops
Control Group:Sodium Hyaluronate Eye Drops and Olopatadine Hydrochloride Eye Drops
Sponsors
Beijing Childrens Hospital,Capital Medical University
Eligibility
Sex/Gender
All
Age
5 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1.Aged 5–12 years old, no gender restriction; 2.The child has at least one of the following subjective symptoms: dryness, foreign body sensation, burning sensation, fatigue, discomfort, fluctuations in visual acuity, or frequent blinking; additionally, the Non-Contact Tear Break-Up Time (NIBUT) is classified as Grade 1 or 2 (NIBUT < 10s), which meets the diagnostic criteria for dry eye as specified in the Chinese Expert Consensus on Dry Eye: Examination and Diagnosis (2020); 3.Diagnosed with allergic conjunctivitis by an ophthalmologist, in line with the Guidelines for Allergic Conjunctivitis (2020); 4.Voluntarily participates in this study with parental consent and signs a written informed consent form;
Exclusion criteria
Exclusion criteria: 1.Patients with uncontrolled active ophthalmic diseases that may affect the reliability of clinical trial observations, such as complicated infectious ophthalmic diseases (viral, bacterial, fungal, protozoal), uveitis, nasolacrimal duct obstruction, intraocular infection, etc.; 2.History of ocular herpes; 3.Patients with exophthalmos or lagophthalmos; 4.Patients with limbal stem cell abnormalities or ocular surface diseases caused by other factors (e.g., thermal burns, chemical burns, etc.); 5.Patients who wear contact lenses during the study period; 6.Patients with uncontrolled systemic diseases or other conditions deemed unsuitable for participation in this study by researchers; 7.Patients with severe cardiac, pulmonary, hepatic, or renal dysfunction; 8.Psychiatric patients; 9.Patients with active ocular infections or a history of allergies to any components of the drugs or tests scheduled for use in the study (e.g., cyclosporine, fluorescein, etc.); 10.Patients who used dry eye-related anti-inflammatory drugs (e.g., immunosuppressants, glucocorticoids, non-steroidal anti-inflammatory drugs [NSAIDs], etc.) within 2 weeks prior to enrollment; 11.Patients receiving systemic medications that may affect the evaluation of the study results (e.g., immunosuppressants, glucocorticoids, etc.); 12.Patients requiring local medications that may affect the evaluation of the study results (e.g., immunosuppressants, intraocular pressure-lowering drugs, NSAIDs, anticholinergic drugs, etc.); 13.Patients who have participated in or are currently participating in other clinical trials within 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in NIBUT from baseline at 3 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in NIBUT from baseline at 3 months; | — |
Countries
China
Contacts
Public ContactQi Lin
Beijing Childrens Hospital,Capital Medical University
Outcome results
None listed