Effect of a Nano-Sized Lipid-Based Eye Drop on Diabetic Dry Eye.

Background

Dry eye disease (DED) is currently recognized as a global health concern, with a prevalence that ranges from 5% to 75%. Given the severity of dry eye in diabetic patients and the global prevalence of diabetes, it is crucial to evaluate new treatments that potentially improve tear film stability in this patient population.

Methods

Single-center, open-label, single-arm, and interventional study in adult patients with type-2 diabetes mellitus and all DED subtypes evaluating a propylene glycol-hydroxypropyl guar nanoemulsion that has shown in previous studies to improve tear film stability in nondiabetic patients.

Results

After 28 days of treatment, the Ocular Surface Disease Index (OSDI) scores showed significant improvement, decreasing from a baseline mean of 42.72 ± 17.69 to 25.53 ± 17.14 on Day 28 (p < 0.001); Non-Invasive Keratograph Break-Up Time (NIKBUT) also improved significantly, increasing from 3.45 ± 1.17 s at baseline to 5.94 ± 1.48 s on Day 28 (p < 0.001). No significant changes were observed in the infrared meibography score (baseline: 1.48 ± 0.93 vs. Day 28: 1.47 ± 0.92, p = 0.279), tear meniscus height (TMH) (baseline: 0.25 ± 0.10 mm vs. Day 28: 0.25 ± 0.08 mm, p = 0.086), or meibomian gland expressibility score (MGES). The redness score significantly decreased from 1.88 ± 0.68 at baseline to 1.40 ± 0.59 on Day 28 (p < 0.001).

Conclusions

These findings suggest notable improvements in both signs and symptoms of dry eye disease in diabetic patients with all DED subtypes and severity categories.