Hyaluronic acid (HA), a natural component of the tear film, is a well-established active
      ingredient in artificial tears and has been reported to improve corneal and conjunctival
      staining in patients with DED. Thealoz Duo (Laboratoires Thea, Clermont Ferrand, France) is a
      novel artificial tear preparation containing two active ingredients: trehalose, a naturally
      occurring disaccharide with anhydrobiotic functions in many organisms, and hyaluronate, a
      widely distributed anionic glycosaminoglycan polysaccharide with lubricative and
      water-retaining properties in biological systems. The purpose of the current study is to
      investigate the effect of the Hyabak and Thealoz Duo in treatment of DED.

Comparison of Two Types of Artificial Tears

Dry Eye Disease

The patients will be treated with Thealoz Duo (at least 3 times daily) in one eye and with
      Hyabak (at least 3 times daily) in the other eye, based on randomization table. Both Hyabak
      and Thealoz Duo are preservative free. The doctors who examine the patients will not get any
      information about the choice of artificial tears in each eye. Besides the artificial tears,
      if necessary, the patients will receive other treatments, for instance, steroids,
      cyclosporine etc., according to their dry eye severity.

Thealoz Duo (combination of trehalose and hyaluronate) eye drop and Hyabak (hyaluronate) eye drop

Comparison of the Efficacy of Two Types of Artificial Tears in the Treatment of Dry Eye Disease

Ocular Surface Disease Index (OSDI) dry eye questionnaire

Without anaesthesia, recorded as mm in length of wetting after 5min

Fluorescein staining at the conjunctiva and cornea. Recorded using oxford scheme, range 0-15

Evaluated by application of light pressure using cotton tips on the central five MGs of the lower eyelid. Expression was graded according to the number of the MGs with meibum secretion under pressure: grade 0: 5 glands; grade 1: 3-4 glands; grade 2: 1-2 glands; grade 3: 0 gland

The quality of the meibum that was secreted from each gland was graded as following: 0, clear; 1, cloudy; 2, cloudy with particles; and 3, toothpaste like. The sum of the score of the central 8 glands in the lower eyelid will be recorded

Patients will be asked about which artificial tear they prefer

A multiplex Luminex® bead-based assay will be used to analyze cytokines from the tear samples. The cytokines to be analysed include 27 different cytokines, including interleukin 1b (IL-1b), IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12p70, IL-13, IL-15, IL-17A, IL-1 receptor antagonist (IL-1ra), eotaxin, basic fibroblast growth factor (bFGF/FGF2), granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GM-CSF), interferon gamma (IFN-γ), interferon gamma-induced protein 10 (IP-10), monocyte chemoattractant protein 1 (MCP-1), macrophage inflammatory protein 1α (MIP-1α/CCL3), MIP-1b, platelet-derived growth factor bb (PDGF-BB), regulated-on-activation normal T cell expressed and secreted (Rantes), tumor necrosis factor alpha (TNF-α), and vascular endothelial growth factor (VEGF).

Thealoz Duo, a combination of trehalose and hyaluronate, will be used on one of the selected eyes of a patient, at least 3 times daily

Hyabak, sodium hyaluronate, will be used on the other eye of the patient, at least 3 times daily

Comparison of Two Types of Artificial Tears

About this trial

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Placebo

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