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.

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™ 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.