Abstract:Background: Moderate to severe dry eye disease (DED) is associated with significant pain, limitations in performing daily activities, reduced life quality, and often depression. This work aimed to evaluate the effectiveness and safety of cyclosporine A (CsA) ophthalmic emulsion in moderate to severe dry eye patients.
Methods: This controlled, randomized, double-blinded study was conducted on forty patients at least 18 years of age, both sexes, diagnosed with keratoconjunctivitis sicca, whether or not it was accompanied by Sjogren's syndrome. The patients were allocated to two equal groups: Group A: patients were treated twice daily with 0.1% cyclosporine A, and Group B: patients were treated twice daily with the vehicle in both eyes for 12 weeks.
Results: Oxford grading scale was significantly higher at 4w, 8w, 12w and 4w posttreatment in group A in comparison to group B (P<0.05). The Schirmer tear test was considerably higher at 4w posttreatment in group A compared to group B (P<0.001). The severity of superficial punctate keratitis was significantly lower at 4w, 8w, 12w and 4w posttreatment in group A than in group B. Visual analogue scale and ocular surface disease index were markedly lower at 4w, 8w, 12w and 4w posttreatment in group A in contrast to group B (P <0.05). Intraocular pressure, visual acuity and CsA were insignificantly different between both groups.
Conclusions: CsA 0.1% was effective as it substantially alleviated the ocular signs and symptoms of moderate-to-severe DED, it reduced the eye dryness score and reduced the disease's impact on vision-related activities. Additionally, it is well-tolerated and safe.
