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OSDI scores at baseline and during treatment at baseline and after 7 days’ treatment with Thealoz Duo ® or Systane ®. 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. Dry eyes can be either natural, generic (passed down from family members with eye problems) or environmental depending on the health of your eyes. Dry eyes can be caused by the following natural, generic or environmental situations:
The efficacy analyses were performed on the intent-to-treat sample (those randomized patients who received at least one drop of study medication and who provided at least some data for the primary efficacy variable). The safety analysis was performed on the safety sample (those patients who received at least one drop of study medication). Sodium hyaluronate adds moisture by retaining water to hydrate and lubricate the surface of the eye 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 ®. Patients were randomized to Thealoz Duo ® or Systane ®. Both treatments were administered as one drop five times daily in both eyes for 7 days followed by a washout period of 5 days, whereupon patients switched to the alternate treatment for 5 days. The two treatments were presented in different 10 mL bottles. As the bottle design is an integral part of the product conventional treatment, blinding was not possible. The study was a single center randomized, open label, crossover trial. Thealoz Duo ® was compared with an active control Systane ®, an established and effective treatment in dry eye.Palpebral signs including meibomitis and other blepharitis, conjunctival discharge, chemosis, folliculo-papillary conjunctivitis, filamentary keratitis, and other relevant ocular signs were evaluated in each eye at days 0, 7, 12, and 19. Palpebral signs were evaluated on a four-point scale (0= none, 1= mild, 2= moderate, 3= severe). Pregnant or breast-feeding women or fertile women not using an effective means of contraception were excluded. 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 NOTE: Please ensure that you wash your hands before using any of these products to prevent possible infection of your eyes.
The Schirmer test was performed, without anesthesia, in each eye at visits on days 0, 7, 12, and 19. contains 30 single-use unit doses. Once the vial has been opened throw away, even if there is a small amount left, do not reuse. Once opened the microbial protection of the solution cannot be guaranteed. Clinically proven to stabilize tear film, reduce inflammatory markers and restore normal osmotic balance. A global ocular staining score was determined from the Oxford 0–5 grading scheme that assesses global ocular staining in corneal area from fluorescein coloration and in temporal and nasal areas from lissamine green coloration in both eyes. Ocular staining was measured during visits at days 0, 7, 12, and 19. 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.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 Thealoz Duo is most advanced preservative-free combination of Sodium Hyaluronate and Trehalose – for lubrication, hydration and protection of all dry eyes THEALOZ ® DUO on ainutlaatuinen, kolmivaikutteinen silmätippa, joka sisältää kosteutta sitovaa trehaloosia sekä kostuttavaa ja voitelevaa hyaluronihappoa. Valmisteen suolapitoisuus on matala eli hypotoninen. Sen vuoksi sillä voidaan normalisoida kuivasilmäiselle tyypillinen kyynelnesteen liian korkea suolapitoisuus ja palauttaa kyynelnesteen luonnollinen osmoottinen tasapaino. Säilytysaineeton ja fosfaatiton Thealoz Duo kostuttaa jopa 6 kertaa pitempään kuin muut silmätipat. Thealoz Duo -silmätippojen koostumus on patentoitu. Oxford fluorescein staining scores at baseline and during treatment baseline and after 7 days’ treatment with Thealoz Duo ® or Systane ®.
Other efficacy analyses are presented as descriptive statistics for baseline, under treatment, and change from baseline (when applicable). Comparison between treatments was performed for quantitative criteria using Student’s t-test for paired samples or a Wilcoxon signed-rank test. A P-value less than 0.05 was considered statistically significant. Thealoz® Duo dry eye drops are suitable for all dry eye sufferers looking for the latest drop. They contain a unique combination of ingredients (trehalose plus sodium hyaluronate) that deliver long-lasting symptom relief(1) and protection for the surface of the eye.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. YHTEISVAIKUTUKSET: Silmään käytettävien eri valmisteiden annostelun välillä on pidettävä vähintään 10 minuutin tauko.
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