other·ophthalmology, dry eye, endocrinology, clinical trial, research methods·PMC10714480
A protocol for a single center, randomized, controlled trial comparing the clinical efficacy of 3% diquafosol and 0.1% hyaluronic acid in diabetic patients with dry eye disease
Trials · 18 authors, 9 centres
AI SUMMARY
FIDELITY 100%
This summary was generated by AI from a single paper. It has not been reviewed by a clinician and is not clinical advice. Verify against the source before acting on it.
No trial results have been reported; the paper describes only the planned methods, outcomes, and statistical analysis.
Full summary
733 CHARS
The primary outcome is non-invasive tear breakup time (NITBUT). Secondary outcomes include conjunctivocorneal staining score, tear film lipid layer score, tear meniscus height, corneal sensitivity, tear MMP-9 levels (assessed at week 8 only), meibomian gland expression and quality, conjunctival hyperemia score, corneal nerves and immune/inflammatory cells via confocal microscopy, and OSDI questionnaire score. Between-group comparisons will use analysis of covariance with baseline as covariate, and within-group comparisons will use paired t-tests. Intention-to-treat analysis is planned with best-available imputation for missing data. The study aims to address the gap in evidence for DQS efficacy in diabetic DED specifically.
