Piiloset Trehalose Emulsion Eye Drop Study in Moderate or Severe Dry Eye
Condition: Dry Eye Syndrome
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Study type: Interventional

Summary: 
      The study evaluates the safety, ocular tolerability and efficacy of emulsion eye drops with
      sacha inchi seed oil, trehalose and hyaluronic acid in the treatment of moderate or severe
      dry eye in adult patients. The investigative device is studied in comparison with control eye
      drops containing hyaluronic acid for up to 30 days.
    

Detailed description: 
      According to the current view on dry eye disease, tear film instability, tear film
      hyperosmolarity, and ocular surface inflammation and damage are identified as etiological
      factors. The first-line medicinal management options include ocular lubricants such as eye
      drops and sprays. Emulsion eye drops are a relatively recent entity among topical therapies
      with an intention to account for deficiencies in the outermost lipid layer of the tear film.

      Piiloset Trehalose Emulsion Eye Drops was developed to target and restore the three main
      layers (mucin, aqueous, and lipid) of the tear film and to counteract the key etiological
      factors leading to dry eye. Hyaluronic acid and the oil component are intended to restore
      tear film instability, the hypo-osmolar composition and trehalose as an osmoprotectant are
      intended to protect the ocular epithelium against hyperosmolarity, and ocular surface
      inflammation and cellular damage are prevented by the cytoprotective and/or anti-oxidative
      action of hyaluronic acid, trehalose, and sacha inchi oil components. Additional water
      binding in the tear film is provided by hyaluronic acid, trehalose, and glycerol. Lubricating
      the ocular surface by high-molecular-weight hyaluronic acid will extend the precorneal
      retention time. Adjustments made to certain physical and chemical parameters in the
      formulation are anticipated to improve tear film spreading and adhesion. The optically clear
      o/w emulsion formulation is free of preservatives, materials of animal origin, phosphates, or
      alcohol. The combined action of the individual components is expected to produce clinically
      relevant mitigation of the signs and symptoms of dry eye.

      The study comprises three Parts with scheduled visits on Day 1 (all Parts) and on
      end-of-study date (Parts 2 and 3) to the study centre. Each study subject will participate in
      no more than one Part of the study.
    

Intervention name(s): Piiloset Trehalose Emulsion Eye Drops; Control Eye Drops
Intervention type(s): Device; Device
Intervention description(s): Topical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops 3 times daily; Topical application of preservative-free multidose Hyaluronic Acid Eye Drops 3 times daily
Intervention MeSH terms: Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Part 1. Piiloset Trehalose Emulsion Eye Drop is administered on the worst eye four times during office hours of one day at the study centre.
Part 2. Piiloset Trehalose Emulsion Eye Drop is self-administered on a randomized eye and the control eye drops on the contralateral eye three times a day for 10 days in a double-blinded fashion.
Part 3. Either Piiloset Trehalose Emulsion Eye Drop or the control eye drops are self-administered on both eyes three times a day for 30 days in a randomized and double-blinded fashion.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lubricant Eye Drops; Moderate or Severe Dry Eye; Hyaluronic Acid; Trehalose; Disaccharides; Polysaccharides; Fatty Acids, Omega-3; Tears; Osmolar Concentration; Anterior Eye Segment; Severity of Illness Index