Overall global efficacy was assessed by both patient and investigator at the end of each treatment period. The investigator assessed efficacy on a four-point scale (0= “very satisfactory” to 3= “unsatisfactory”). The patient assessed efficacy in the domains of effectiveness (nine questions) and inconvenience (three questions). Every individual question was scored from 0 (greatly disagree) to 3 (greatly agree). The sum of all the individual scores provided the global score of effectiveness and inconvenience. Trehalose protects the epithelial cells on the ocular surface, improving their resistance to daily stress of dry environments and tear film changes in a dry eye; it has very high water retention capabilities with both bioprotection 1,2 and osmoprotection properties 2-7 This study indicates that patient satisfaction improved with both Thealoz Duo ® and Systane ® although Thealoz Duo ® resulted in significantly greater improvement in patient satisfaction than did Systane ®. On secondary efficacy variables, Thealoz Duo ® was at least as effective as Systane ® on secondary efficacy variables: OSDI, staining, ocular signs, Schirmer/BUT, patient satisfaction/global efficacy (patient and investigator), and patient preference. Moreover, there was a significant advantage for Thealoz Duo ® in dry eye symptoms on impact on work. However, this was a relatively small study, and the duration of treatment was relatively short, which likely explains the inconsistency between the results on some parameters. Although some parameters (OSDI, for example) did not show statistically significant differences between the two treatments, the direction of the trends between the treatments was consistent; where statistically significant differences were observed between the treatments, they were all in favor of Thealoz Duo ®.

Administrative exclusions included participation in another clinical study or the exclusion period of another study, previous participation in the current study, and the patient being under guardianship. Dry Eye means that your eyes may not be making enough tears, the tears you are making are of poor quality or evaporate faster than they should.Thealoz Duo ® (Laboratoires Théa, Clermont Ferrand, France) is an artificial tear preparation containing two active ingredients: trehalose, a naturally occurring disaccharide of glucose that appears to function in an anhydrobiotic capacity in many organisms, and hyaluronate, a widely distributed anionic glycosaminoglycan polysaccharide with biological roles associated with its lubricative and water-retaining properties. Trehalose has been shown not only to stabilize both bilipid membranes and labile proteins against desiccation, but also to have a protective effect against desiccation and oxidative insult in the mammalian eye. 4 Hyaluronate is a component of many medicinal preparations including those used in cataract surgery, for the treatment of dry eye as well as many commercial skin preparations and antiaging creams. 5 It is also present in natural human tears. 6 Dry eye is a condition where the surface of the eye becomes inflamed and sore due to a poor relationship between the tear film and the eyelids. This might be because your eyes are not producing enough tears, or that the chemistry of the tear film is out of balance. The primary endpoint was analyzed using a mixed-effects analysis of covariance, considering the patient within the sequence as a random effect and using the type III Sum of Squares for evaluation of the effect. NOTE: Please ensure that you wash your hands before using any of these products to prevent possible infection of your eyes.

We recommend you apply 1 drop to each eye from 4 to 6 times daily, however this can increase or decrease without any cause for concern, dependant on the severity of your symptoms OSDI scores at baseline and during treatment at baseline and after 7 days’ treatment with Thealoz Duo ® or Systane ®. Thealoz Duo is most advanced preservative-free combination of Sodium Hyaluronate and Trehalose – for lubrication, hydration and protection of all dry eyes To help reduce or eliminate these symptoms, Thealoz Duo works in several ways due to the active ingredients Trehalose (as in Thealoz) and Sodium Hyaluronic Acid (also known as Hyabak). It is also free from preservatives.

KOOSTUMUS: Trehaloosia (3 %), natriumhyaluronaatti (0,15 %), natriumkloridi, trometamoli, kloorivetyhappo ja injektionesteisiin käytettävä vesi. Trehalose-containing eyedrops have previously been shown to be effective in in vitro, 9, 10 ex vivo, 11 and in vivo animal studies 12 as well as in a few clinical studies. 13– 15 A further advantage of this formulation is a longer residency time than hyaluronate alone, as recently shown in a randomized, double-masked study. 16 Clinical studies have investigated the use of trehalose in eyedrops with positive results. These larger studies established significant benefits of trehalose-containing eyedrops over saline and hydroxymethylcellulose eyedrops. 13, 14 The utility of hyaluronate-containing eyedrops is well established in the treatment of dry eye. 17– 22