Summary
AIM: To document real-world patient characteristics, utilisation patterns, and clinical outcomes with Artelac Ultra 4S (AS) lubricating eye drops (sodium hyaluronate, trehalose, fucoidan, D-panthenol) in patients with dry eye disease (DED).
METHODS: This retrospective, multi-country, cross-sectional case review study included currently licensed ophthalmologists with ≥3 years' experience treating patients with DED, and ≥1 years' experience with ≥1 of the DED study drops. Healthcare providers (HCPs) provided a deidentified, retrospective convenience sample of lubricating eye drop cases using a standardised case report form. The protocol received central institutional review board exemption. Here, we report the sub-analysis of patients treated with AS.
RESULTS: This interim sub-analysis included five cases from one ophthalmologist unless otherwise specified. Patients had a mean±SE age of 47.4±7.9 years, were all female, were not contact lens users, and 40% had ocular comorbidities (including previous cataract surgery and glaucoma). Two patients received prior DED treatment (hyaluronic acid-based drops), which were not considered effective enough in both patients. All patients used AS lubricating eye drops QID. At a mean±SE follow-up of 37.2±2.9 weeks, improvements from baseline were reported in mean tear break-up time (TBUT) and Schirmer test. In all cases, the HCP reported improvements in the signs, symptoms, and patient-reported symptoms of DED. In 4/5 cases, clinical effectiveness was rated as "very effective" (one case was ranked as "somewhat effective"), with no tolerability concerns reported. Additionally, no treatment-related adverse events related to the study drug were reported.
CONCLUSIONS: In this real-world retrospective case review, most HCPs considered AS to be very clinically effective, with patients experiencing decreased signs and symptoms, with no tolerability concerns and no adverse events reported.