Dry eye disease
Conditions
Interventions
3D digital music therapy:3D digital music therapy twice daily for 8 weeks, with one session during the daytime and another before bedtime.
0.3% sodium hyaluronate eye drops:0.3% sodium hyaluronate eye drops administered to both eyes (1 drop four times daily) for 8 weeks.
Sponsors
Eye & ENT Hospital of Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients aged 18 years or older with a clinically supported diagnosis and a history of bilateral dry eye disease, or a history of subjective symptoms for at least 6 months prior to baseline (including dryness, foreign-body sensation, burning, eye fatigue, discomfort, fluctuating vision, etc.). At baseline, Ocular Surface Disease Index (OSDI) scores must be within 18–80, and tear film break-up time (BUT) <= 8 seconds. Participants must be willing and able to comply with all trial assessments and visits as instructed.
Exclusion criteria
Exclusion criteria: Exclusion criteria included: structural or functional eyelid abnormalities (excluding blepharitis and moderate-to-severe meibomian gland dysfunction); Schirmer test score <2 mm/5 minutes without anesthesia in either eye at baseline; use of topical ophthalmic medications beyond study-provided treatments (including IOP-lowering agents, eye drops, gels, or artificial tears) or physical meibomian gland therapies (e.g., massage, intense pulsed light) during the study; active anterior segment disease, ocular/periocular malignancies, or glaucoma; lacrimal system inflammation, infection, stenosis, or obstruction; cicatricial dry eye disease; recent ocular surgery (corneal refractive surgery within 2 years, intraocular surgery within 12 months, eyelid or ocular surface surgery within 6 months, or punctal occlusion/cauterization within 3 months); autoimmune diseases including Sjögren's syndrome, or use of medications known to induce dry eye within 3 months before baseline; pregnancy, lactation, or planned pregnancy in female subjects; uncontrolled systemic disease; concurrent enrollment in other clinical trials; and any condition deemed inappropriate for study participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ocular Surface Disease Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tear Break-Up Time;Corneal Fluorescein Staining;Tear inflammatory factors;Self-Rating Depression Scale,SDS;Pittsburgh Sleep Quality Index,PSQI;Subjective Happiness Scale,SHS; | — |
Countries
China
Contacts
Public ContactLan Gong
Eye & ENT Hospital of Fudan University
Outcome results
None listed