ABSTRACT
PURPOSE: To evaluate the efficacy and safety of two ophthalmic solutions in patients with mild to moderate dry eye. METHODS: We performed a prospective, 2-month-long, randomized, double-blind, single-center, parallel clinical trial to compare the efficacy and safety of two ophthalmic solutions for dry eye treatment. Patients were randomly assigned to one of the two treatment groups, study group or active-control group, and received one drop four times a day. The primary efficacy endpoint was to extend the tear film break-up time (TBUT) after 2 months of treatment. The Ocular Surface Disease Index (OSDI) was also evaluated. Safety measures were assessed by the presence of adverse events. RESULTS: A total of 28 patients with mild to moderate dry eye were included in the per protocol analysis. TBUT was similar between groups at baseline (chondroitin sulfate and xanthan gum [CS/XG] group, 5.2 ± 2.3; Systane(®) group, 4.7 ± 2.6; P = 0.488), after 2 months of treatment, TBUT was still similar in both groups (CS/XG group, 6.1 ± 2.5; Systane(®) group, 7.3 ± 2.5; P = 0.088). Baseline OSDI was similar between the groups (CS/XG group, 18.8 ± 5.3; Systane(®) group, 19.8 ± 7.1; P = 0.810), but after 2 months of treatment, the OSDI was significantly lower in the CS/XG group (6.7 ± 5.7 versus 10.8 ± 6.4; P = 0.049). An adverse event was present in the CS/XG group, but it was not related to the treatment. CONCLUSIONS: In this population of patients with mild to moderate dry eye, treatment with CS/XG was as effective as treatment with Systane(®) with regard to TBUT; nevertheless, treatment in the CS/XG group was more effective at diminishing OSDI.
