Introduction: The dry eye disease (DED) is a common disease and a frequent reason for consultation at community pharmacy. DED has a high impact on patients’ quality of life (QoL); therefore, an appropriate treatment should aim to improve it. Artificial tears constitute the cornerstone for DED management and the main treatment recommended by pharmaceutical indication.
Objective: To study the effect of eyedrops based on hyaluronic acid, Centella asiatica and Aloe vera on the QoL of patients with DED. In parallel, treatment adherence, tolerance and safety of the product were evaluated.
Methods: Post-authorization, open, prospective and multicentric clinical study. Patients received the treatment for 60 days. To study the effect on QoL, patients completed the OSDI© questionnaire before starting the treatment, and at 30 and 60 days of treatment. Treatment adherence was assessed by means of units’ reconciliation and the safety, through adverse events monitoring.
Results: Patients treated with eyedrops, Intention to treat (ITT, n=44), obtained clinically important improvements in their QoL, symptomatology and visual function, as the OSDI© score decreased from 32.80 (DE=23.00) (severe DED) at baseline to 12.64 (DE=15.32) (normal status, p<0.001), and 9.22 (DE=10.37) (normal status, p<0.001), at 30 and 60 days, respectively. Over 70% of patients adhered to the treatment. The safety profile was favourable. Four Mild intensity ocular adverse events were observed. No security concerns were raised.
Conclusions: The studied eyedrops might be an effective and safe treatment option to improve the QoL of patients with DED.