Open Not Comparative Clinical Trial on the Performance and Tolerability of the Medical Device LACRIACT, Eye Drops for the Treatment of Dry Eye

Dry eye disease is defined as a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and subacute inflammation of the ocular surface (Ocul Surf. 2007;5(2):75). Tear hyperosmolarity is responsible for several morphological changes in conjunctival and corneal cells, and stimulation of the inflammatory cascade, resulting in the release of mediators such as cytokines and proteolytic enzymes, loss of both mucin-producing goblet cells and corneal barrier function. The international literature shows that ophthalmic products containing the biologic glycosaminoglycan sodium hyaluronate (HA) at concentrations around 0.2% (between 0.15% and 0.25%) are well tolerated and no safety problems have been reported. In fact, being hydrophilic, HA binds a large amount of water and forms a viscous hydrated gel even at low concentrations, which helps to restore and stabilize the compromised tear film in dry eye patients. Recently, the use of osmoprotectants, which are able to counteract the hyperosmolarity of the tear film, has been evaluated as a beneficial strategy for the treatment of dry eye. Osmoprotection can be considered as a natural response of biological structures that, through the accumulation of small biological molecules on cell surfaces, causes an adaptation of these structures to a hyperosmotic environment. For this reason, the selection of new osmoprotective agents for the treatment of dry eye should be a goal of current clinical research in ophthalmology. LABORATORI BALDACCI has recently selected 5-oxo-2-pyrrolidinecarboxylic acid (PCA), known as pyroglutamic acid, an endogenous molecule able to meet the expectations of demonstrating beneficial behavior in reducing dry eye symptoms. The medical literature (Tampucci S et al, Pharmaceutics. 2018), demonstrated that the scarce tear volume in contact with the corneal epithelial cells in atropine-induced dry eye in rabbits was influenced by the presence of hydrophilic PCA, which was able to provide protection against desiccation due to its osmoprotective activity and high water-binding capacity, thereby maintaining a significant tear volume in the conjunctival sac. Furthermore, the combination of PCA and HA allows for a significant improvement in this behavior, probably due to the ability of HA to hold approximately 1000 times its weight in water with respect to the surrounding tissue. These positive preclinical results should be confirmed in the ongoing clinical trials. The combination of PCA as an osmoprotective agent and HA as a pharmaceutical mucoadhesive and viscosifying agent capable of optimizing the ocular pharmacokinetic behavior of PCA may be a promising combination for the treatment of dry eye.

LACRIACT®, the medical device ophthalmic solution used in this clinical trial, was designed to act locally without the need for systemic absorption. In fact, PCA and HA are physiological substances that do not present toxicity issues. LACRIACT® was formulated to alleviate dry eye symptoms through localized physical action, without involvement of any immunological or pharmacological activity, and minimizing discomfort upon application.

This open, non-randomized trial will take place at an Italian clinical site. The purpose is to assess the performance, safety, and tolerability of LACRIACT® eye drops in patients with mild to moderate dry eye syndrome, with or without contact lenses. The investigators opted to treat solely mild to moderate dry eye because severe forms of dry eye necessitate a comprehensive approach where tear substitutes constitute only a part of the therapy. Assessing the efficacy and tolerance of LACRIACT becomes more complex when used with concomitant local and systemic dry eye treatments. The sample size has been determined to be 20 evaluable patients, and the Investigators plan to screen 22 patients to achieve this number (allowing for 2 screening failures). Dropouts will not be replaced. The Investigator may include a maximum of 10 patients (out of a total of 20) who regularly wear soft contact lenses, but this is optional.