Evaluation of the usability, efficacy and safety of a novel ophthalmic eye drop dispenser designed to deliver preservative-free artificial tears for the treatment of dry eye disease

Abstract

Background Ocular conditions are often managed with eye drops but conventional dispensers may be difficult to use for some. Objectives A novel device has been designed to overcome limitations of traditional eye drop dispensers, and its ability to deliver artificial tears was tested. Design A single centre, prospective study of 24 patients with Dry Eye Disease (DED).Methods Regular users of artificial tears tested the novel dispenser over 4 weeks, evaluating: DED symptoms with the Dry Eye Questionnaire 5; ocular parameters including the non-invasive tear breakup time (NI-TBUT), the Schirmer I test and surface staining; and tear meniscus parameters (height, depth and area measured by AS-OCT before and after application). The patients used questionnaires to evaluate the usability and their satisfaction with the dispenser, and report any adverse reactions. Results Tear stability improved after 4 weeks using the dispenser, with a significantly higher NI-TBUT-first (6.48 +/- 3.65 s) and NI-TBUT-average (7.45 +/- 3.59 s) relative to baseline (4.52 +/- 3.18 and 5.95 +/- 3.39, respectively: p=0.001), coupled to milder ocular surface staining (0.54 +/- 0.65) relative to baseline (1.08 +/- 0.77: p=0.042). Artificial tear instillation using the dispenser significantly improved tear meniscus parameters, which persisted for >= 5 min, and the lower mean DEQ-5 score after 4 weeks (9.79 +/- 3.23) relative to baseline (11.20 +/- 3.37: p=0.006) indicated DED symptoms also improved. The patients rated the new dispenser as very easy (58%) or easy (33.3%) to use, and many felt very comfortable using it. Patients were satisfied (54.2%) or very satisfied (16.7%) with the new dispenser, 87.5% preferring it over conventional systems (p<0.001) and with a desire to continue using it. No adverse reactions were reported. Conclusion The Beat the Blink (TM) dispenser was feasible, easy to use, well tolerated, and highly accepted over 4 weeks. Clinical signs and patient-reported symptoms improved during use with preservative-free artificial tears.