Anti-inflammatory Effects and Clinical Efficacy of Topical Thealoz Total Eye Drops in Patients With Chronic Dry Eye Disease and Associated Ocular Surface Inflammation

Dry eye disease (DED) is a highly prevalent ocular condition and induces a significant burden to the affected patients. Regardless of the underlying etiology, DED is associated with increased inflammation of the entire ocular surface including the adnexa, conjunctiva and cornea. As such, there is evidence from in vitro, animal and clinical studies that this inflammatory response of the ocular surface plays a pathophysiological key role in the development of DED. The Dry Eye Workshop 2007 (DEWS) therefore suggests beside of restoring the tear film by administering topical lubricants, breaking the vicious circle of inflammation is an important mainstay of therapy in patients with DED. Recently, a new medical device (Thealoz Total® eye drops) has been introduced for the treatment DED. Thealoz Total® eye drops are based on hyaluronic acid and exert their main action by lubricating the ocular surface. Further, this new formulation offers several advantages that make them potentially interesting to reduce DED related symptoms. First, the formulation is preservative-free, which is of special importance in patients with DED, since it has been shown that preservatives are detrimental for the ocular surface. thereby reducing signs and symptoms related to DED. Secondly, in addition to the lubricating effect of hyaluronic acid, Thealoz Total eye drops also contain trehalose, which exerts osmoprotetive effects and N-Acetyl Aspartyl Glutamic Acid (NAAGA). NAAGA is an amino conjugated dipeptide with anti-inflammatory properties. Thus, it is reasonable to hypothesize that Thealoz total eye drops are also capable of reducing ocular surface inflammation. The aim of the present study is to investigate whether topical administration with Thealoz Total® improves ocular surface inflammation as well as clinical signs and symptoms associated with DED.

NCT Number	NCT07245836
Lead Sponsor	Medical University of Vienna
Conditions	Dry Eye Disease (DED)
Enrollment	30 participants
Start Date	2025-01-20
Primary Completion	2025-06-03 (estimated)
Study Completion	2025-07-06 (estimated)
Updated on ClinicalTrials.gov	2026-05-08