COMPARATIVE EVALUATION OF THE EFFICACY OF VITAMIN A SUPPLEMENTATION VERSUS ARTIFICIAL TEAR LUBRICANTS IN THE MANAGEMENT OF DRY EYE DISEASE AMONG TYPE 2 DIABETES PATIENTS
Keywords:
Artificial tears, Dry Eye, Eye drops, Hylo, Lubricant eye drops, Retin A, Vitamin AAbstract
Background: Dry eye disease is a common complication of type 2 diabetes mellitus, but no studies have directly compared the effect of vitamin A supplementation with artificial tears in people with type 2 diabetes mellitus (TT2DM) to date.
Objective: To compare the efficacy of vitamin A supplementation versus artificial tear lubricants in the management of dry eye disease among type 2 diabetes patients.
Methods: A prospective, parallel-group randomized controlled trial was conducted in Sighton Optix Eye Center. Patients with type 2 diabetes mellitus (T2DM) and mild-to-moderate dry eye disease were recruited and randomly assigned to Hylo artificial tears (n=37) or Retin A vitamin A 10,000 IU (n=37) for six weeks. Sample size was calculated using G*Power 3.1.9.4 (effect size d=0.70, α=0.05, power=95%). Eligible participants were aged 40–70 years with T2DM, OSDI 13–32, TBUT ≤10 seconds, Schirmer I ≤10 mm/5 min. Baseline and post-treatment assessments included OSDI, TBUT, and Schirmer I testing. Data were analyzed using SPSS version 27. Data was tested for normality using the Kolmogorov-Smirnov test with Lilliefors correction. Changes over time and between-group differences were evaluated using repeated-measures general linear modeling with Bonferroni-adjusted comparisons. Statistical significance was set at p<0.05.
Result: Hylo and Retin A had significant effects on reducing dry eye symptoms and clinical signs in T2DM patients during 6 weeks. However, Hylo was significantly more effective, producing lower Week 6 OSDI scores (9.97 ± 2.12 vs. 14.76 ± 2.58; F = 76.25, p < 0.001), greater TBUT improvement in both eyes (mean difference: -1.43 and -1.52 seconds; both p<0.001), and higher Schirmer values (mean difference: -1.49 and -1.28 mm; both p<0.001). Significant between-group differences were also observed for left-eye Schirmer values at Week 6 (F=6.01, p=0.017) and right-eye TBUT at Week 2 (F=7.07, p=0.010).
Conclusion: Both vitamin A and artificial tears improved dry eye outcomes in patients with type 2 diabetes mellitus, but Hylo demonstrated significantly greater improvements in symptoms, tear-film stability, and tear secretion after 6 weeks.
