Clinical Evaluation Of An Artificial Tear Based On Liposomes And Hyaluronic Acid By TBUT Measurements

Abstract

Purpose: : Dry Eye Disease leads to a reduction in quality of life of patients suffering from this disorder. Artificial tears combining components similar to preocular tear film can improve the quality and stability of tear film. In previous works, we have developed an artificial tear (unpreserved) based on liposomes dispersed in a polymeric solution of hyaluronic acid which hypotonicity was adjusted with trehalose. The aim of this work was to test the efficacy of this artificial tear by Tear Break-Up Time (TBUT) measurements.

Methods: : The stability of the tear film was assessed in 10 healthy subjects (age range 25-56 years). Forty microliters of fluorescein solution (2%) (Fluoresceina®, Alcon Cusi, Spain) was instilled in the conjunctival sac of both eyes. Each subject was asked to blink until a uniform film appeared over the cornea. Afterwards, TBUT was determined using a slit lamp with a cobalt blue filter. Results are the mean of three consecutive measurements. TBUT measurements were carried out before treatment and 2 minutes and 30 minutes after the instillation of the liposomal formulation.

Results: : Ocular health was in the normal range for all the volunteers. At baseline, the mean TBUT value was 9.25 ± 2.3 seconds. After instillation of a liposomal drop, there was a significant improvement in tear film stability compared to baseline values (p=0.003) with TBUT values of 11.25 ± 2.1 seconds and 12.7 ± 2.4 seconds for 2 and 30 minutes respectively. There were no statistical differences between TBUT values post-instillation (p=0.112).

Conclusions: : This unpreserved artificial tear formulation leads to a tear film stability improvement at least during 30 minutes after a drop instillation being suitable for dry eye treatment.

Keywords: cornea: tears/tear film/dry eye • cornea: basic science