Effect of Thealoz Duo® on signs, symptoms and inflammatory markers in patients with moderate to severe dry eye disease

Project objectives

Dry eye disease (DED) is a common, multifactorial ocular condition with major impact on vision and quality of life. It is now well recognized that the pathophysiology of chronic DED can include a cycle of inflammation involving both innate and adaptive immune responses (1). Thealoz Duo® topical eye drop treatment composed of the novel promising combination of a natural bioprotectant disaccharide trehalose and sodium hyaluronate was shown to increase the tear film thickness in patients with mild to moderate DED (2) with an improvement in ocular surface parameters and patient satisfaction .(3) Both in vitro and in vivo studies have demonstrated the bioprotective qualities of trehalose in terms of corneal cell desiccation, protection against apoptosis and ultraviolet-induced oxidative damage, and conjunctival inflammation (4-6). Sodium hyaluronate is a natural polysaccharide found in the human eye which holds water to hydrate and lubricate the surface of the eye. It keeps the solution on the eye giving long lasting relief and cutting down the healing time of the corneal epithelium. A decrease in ocular discomfort symptoms, surface damage, and tear cytokine levels was shown after 2 months' treatment with trehalose/hyaluronate tear substitute in DE patients, along with a significant goblet cell density recovery were shown in a recent open label clinical study (7 ). This clinical study has been designed to evaluate, in patients suffering from moderate to severe dry eye syndrome, the effects on signs, symptoms and inflammatory markers of two months of treatment with Thealoz Duo®, compared with Hydroxypropyl Methylcellulose 0.3% (HPMC 0.3%) , a widely used tear substitute prescribed for the same indication.

Start and end date

Project Manager

Coordinating institution of the project

Other Institutions involved

• University of Bologna
• San Giovanni Sorrowful Hospital Company

Funding source(s).

Economic value of the project

30.000 €