Performance and Tolerability of the Medical Device LACRIACT
Condition: Dry Eye; Contact Lens Acute Red Eye; Photophobia; Discomfort
MeSH terms: Photophobia; Dry Eye Syndromes; Keratoconjunctivitis Sicca
Study type: Interventional

Summary: 
      The goal of this study is testing LACRIACT® eye drops, a medical device, to see how well it
      works and if people can use it safely. The Investigators will study this in people who have
      dry eyes, some of whom wear contact lenses, and some who do not. To obtain data from 20
      participants, the investigators will first screen 22 patients, as two of them may not meet
      the requirements. If someone quits the study, the Investigators will not replace them with
      someone else.

      A person can partecipate in the study if they meet certain criteria in the study plan,
      complete the entire treatment, and use eye drops correctly at least 80% of the time. The
      Investigators running the study might also include up to 10 people who wear soft contact
      lenses out of the 20 in total.

      This study will be conducted at a clinic in Italy.
    

Detailed description: 
      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.
    

Intervention name(s): LACRIACT
Intervention type(s): Device
Intervention description(s): LACRIACT is is a preservative free ophthalmic sterile medical device solution. The solution is packaged in closable vials of inert material that does not affect the contents (clear low-density polyethylene), each vial contains 0.5 ml of solution.
Eligible patients will start the treatment. Patients will receive the box of eye drops, and will be instructed on how to self-administer 1 drop in each eye 4 times a day for 30 days starting from the day following the visit.
Intervention model: Single Group Assignment
Intervention model description: Open, non comparative study with a medical device
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: LACRIACT; Contact lens; Photophobia; Stickiness of eyelashes; Italy