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

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.

Inclusion Criteria:

• Age ≥ 18 years
• Normal ophthalmic findings except dry eye disease
• Chronic dry eye defined as longer than six months since diagnosis
• OSDI ≥ 22
• Conjunctival Hyperemia≥ Grade 3 (Efron Scale)
• Current use of topical lubricants since at least 3 months

Exclusion Criteria:

Ophthalmic exclusion criteria

- Best far corrected visual acuity < 1/10

Severe Dry Eye associated with:

• Eyelid malposition
• Stevens Johnson Syndrome
• Corneal dystrophy
• Ocular neoplasia
• Filamentous keratitis
• Corneal neovascularisation
• Orbital radiotherapy
• Dry eye related to GVHD

History of any of the following within last 3 months:

• Systemic treatment of dry eye
• Systemic treatment of MGD
• Isotretinoïde,
• Cyclosporine,
• Tacrolimus, Siromilus, Pimecrolimus
• Punctual plugs

History of any of the following within previous six months:

• ocular trauma
• ocular infection, Ocular allergy

History of any of the following within last 12 months:

• inflammatory corneal ulcer
• Herpetic eye infection or uveitis
• Ocular surgery

Systemic / non ophthalmic exclusion criteria:

- Known hypersensitivity to any of the components of the medical device under investigation or other study medication

Specific exclusion criteria for women:

• Pregnant or breast-feeding woman.
• Woman of childbearing potential (neither menopausal, nor hysterectomized, nor sterilized) not using effective contraception (i.e. hormonal contraceptives, intra-uterine device, contraceptive implant or condoms)

Exclusion criteria related to general conditions

- Inability of patient to understand the investigation procedures and thus inability to give valid, informed consent.