Dry eye disease
Conditions
Interventions
Trial Group:Benzalkonium chloride (BAK)-containing 0.1% hyaluronic acid eye drops, four times daily
Control Group:Preservative-free (PF) 0.1% hyaluronic acid eye drops, four times daily
Sponsors
The General Hospital of PLA
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18–60 years, male or female. 2. Meet the diagnostic criteria for mild to moderate dry eye disease as described above. 3. Voluntarily participate and sign a written informed consent form. 4. Agree not to use other eye drops (except the study medication) or systemic medications that may affect dry eye during the study period.
Exclusion criteria
Exclusion criteria: 1. Severe dry eye (Schirmer I 6 points). 2. Other active ocular diseases (e.g., infection, inflammation, severe meibomian gland dysfunction, ocular trauma, glaucoma, etc.). 3. Known allergy to sodium hyaluronate or benzalkonium chloride. 4. Undergone ocular surgery or laser treatment within the past 3 months. 5. Systemic use of antihistamines, anticholinergics, isotretinoin, or other drugs that may aggravate dry eye within the past 1 month. 6. Pregnant or breastfeeding women. 7. Having severe systemic diseases (e.g., uncontrolled diabetes mellitus, rheumatic immune diseases, psychiatric disorders, etc.). 8. Other conditions deemed by the investigator to be unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in tear MMP-9 concentration from baseline;Change in tear IL-6 concentration from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Ocular Surface Disease Index (OSDI) score;Schirmer I test result;Tear film break-up time (TBUT);Corneal fluorescein staining score (CFS);Tear IL-1ß concentration;Tear TNF-a concentration; | — |
Countries
China
Contacts
Public ContactHuang Yang
The General Hospital of PLA
Outcome results
None listed