Retrospective Real-World Evidence Study: Utilisation Patterns And Clinical Outcomes With Two Types Of Lubricating Eye Drops In Patients With Dry Eye Disease

This study documents real-world patient characteristics, utilisation patterns and clinical outcomes with two different preservative-free lubricating eye drops: Artelac Complete (ArtC) – which contains 0.24% sodium hyaluronate (HA), carbomer and glycerin – and Artelac Ultra 4S (Art4S), which contains HA, trehalose, fucoidan and D-panthenol.

This retrospective, multi-country, cross-sectional case review study included currently licensed eye care practitioners (ECPs) with ≥3 years' experience treating patients with dry eye disease (DED), and ≥1 year’s experience with at least one of the study drops (ArtC, Art4S).

ECPs provided a deidentified, retrospective convenience sample of ≥5 study-drop cases using a standardised case report form. ECPs also completed a survey about their experience. Outcomes included tear film break-up time (TBUT), tear production (Schirmer test), ECP- and patient-reported changes in DED signs/symptoms, ECP-rated effectiveness, tolerability and adverse events (AEs). The study protocol received central institutional review board exemption. An interim analysis was conducted on the results from 10 ECPs (based in Germany, Italy, Poland, Spain, Turkey, and UAE) covering 59 patients treated with ArtC and 19 patients treated with Art4S.

Patients were predominantly female (ArtC, 68%; Art4S, 84%) and not wearers of contact lenses (ArtC, 88%; Art4S, 74%). From diagnostic visit to last available follow-up (mean [SE] 9.6 [1.2] weeks for ArtC, 22.6 [2.8] weeks for Art4S) improvements were reported for TBUT (mean [SE] 5.0 [0.4] seconds for ArtC, 4.4 [0.5] seconds for Art4S) and Schirmer test (mean [SE] 2.8 [0.6] mm for ArtC, 3.3 [1.4] mm for Art4S). ECPs reported improvements in ArtC patients’ signs (59/59) and symptoms (51/59), and in Art4S patients’ signs (19/19) and symptoms (19/19). 57/59 patients treated with ArtC and all patients treated with Art4S reported symptom improvement. No AEs were reported with ArtC; one patient reported an AE (atopia on lids) with Art4S.