COMPARISON THE EFFECTS OF PRESERVATIVE-FREE ARTIFICIAL TEARS VERSUS PRESERVED LUBRICANTS ON TEAR FILM STABILITY AND SLEEPING DISORDER AMONG PATIENTS WITH DRY EYE

Abstract

Background: Dry eye disease (DED) is a multifactorial ocular surface disorder characterized by disruption of tear-film homeostasis, ocular discomfort, visual disturbance, and ocular surface damage. Artificial tears are commonly used as first-line symptomatic therapy. However, preserved formulations may expose the ocular surface to preservatives during repeated administration, whereas preservative-free formulations avoid this additional exposure. The comparative clinical benefits of these formulations remain incompletely established. Objective: To compare the effects of preservative-free artificial tears and preserved lubricants on tear-film stability, tear production, dry eye symptoms, ocular surface integrity, and sleep quality in patients with dry eye. Methods: A randomized controlled study was conducted among 60 patients with dry eye. Participants were equally allocated to two groups. Group A received preservative-free artificial tears, while Group B received preserved lubricants for eight weeks. Outcome measures included Tear Break-Up Time (TBUT), Schirmer I Test, Ocular Surface Disease Index (OSDI), Pittsburgh Sleep Quality Index (PSQI), and fluorescein corneal staining. Data were analyzed using SPSS. Normality was assessed using the Shapiro–Wilk test. Paired-samples and independent-samples t-tests were used for continuous variables, while categorical variables were compared using the Chi-square test. Statistical significance was set at p < 0.05. Results: Both groups demonstrated statistically significant improvement in all measured outcomes after treatment (p < 0.001). In Group A, TBUT increased from 5.42 ± 1.12 to 9.18 ± 1.36 seconds, Schirmer I increased from 7.83 ± 1.54 to 12.47 ± 1.76 mm/5 min, OSDI decreased from 42.63 ± 6.84 to 19.84 ± 5.26, PSQI decreased from 10.13 ± 1.92 to 5.87 ± 1.48, and fluorescein staining decreased from 3.87 ± 0.82 to 1.23 ± 0.51. Group B also showed significant improvement, with TBUT increasing from 5.36 ± 1.18 to 7.48 ± 1.41 seconds, Schirmer I from 7.70 ± 1.49 to 10.26 ± 1.68 mm/5 min, OSDI decreasing from 43.10 ± 6.57 to 28.74 ± 5.91, PSQI from 10.37 ± 2.01 to 7.63 ± 1.72, and fluorescein staining from 3.81 ± 0.79 to 2.08 ± 0.63. Post-treatment comparisons favored Group A for all outcomes (p < 0.001).

Conclusion: Both treatments improved signs and symptoms of dry eye. In this study, preservative-free artificial tears produced greater improvements in tear-film stability, tear production, symptom severity, ocular surface staining, and sleep quality than preserved lubricants.