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Christina Jacobi, Friedrich E. Kruse, Claus Cursiefen; Prospective, Randomized, Controlled Comparison Of SYSTANE UD Eye Drops Versus VISINE INTENSIV 1% EDO Eye Drops For The Treatment Of Moderate Dry Eye. Invest. Ophthalmol. Vis. Sci. 2011;52(14):3827.
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The aim of this prospective, randomized, clinical, single-centre study was to compare the safety and efficacy of two ocular surface lubricant eye drops: preservative-free hydroxypropyl (HP)-Guar (SYSTANE UD) eye drops versus preservative-free Tamarindus Indica Seed Polysaccharide (TSP) 1% (VISINE INTENSIV 1% EDO) eye drops. HP-Guar is suggested to preferentially bind to the more hydrophobic, desiccated or damaged areas of the surface epithelial cells, providing temporary protection for these cells. TSP possesses mucomimetic, mucoadhesive and pseudoplastic properties. The mucin-like molecular structure of TSP is similar to corneal and conjunctival mucin 1 (MUC1), a transmembrane glycoprotein thought to play an essential role in protecting and wetting the corneal surface.
28 patients (age 44±8, 9 males and 19 females) with moderate keratoconjunctivitis sicca were enrolled in the trial. Patients were randomised for two treatment groups (SYSTANE UD eye drops versus VISINE INTENSIV 1% EDO eye drops) which were applied five times per day for three months. No other concurrent ocular therapy was used. Inclusion criteria were typical symptoms measured by a validated questionnaire (Ocular Surface Disease Index questionnaire Score, OSDI) >10, a tear break up time (TBUT)<10sec, a Jones-Test<10mm and LIPCOF>2. OSDI-Scores were evaluated prior to and after the treatment. Statistical analyses were performed using StatisticaTM software (Mann-Whitney-U-Test, Wilcoxon-Test), p-values < 0.05* were considered significant.
After three months of treatment the patients of both groups had subjective benefit in the relief of symptoms of dry eye disease evaluated by the OSDI-Score. No significant changes were recorded in tear secretion measured by the Jones-Test in both groups compared with baseline results (HP-Guar group: p=0.092; TSP group: p=0.08). Patients treated with HP-Guar showed significant improvements in tear film stability measured by TBUT (p=0.039*).
The results of this clinical trial show improvements of symptoms and signs in patients with moderate dry eye after the consistent use of HP-Guar and TSP lubricant eye drops, which are designed to act on the mucus and aqueous layers of the tear film, replacing lost moisture and stabilising the tear film. HP-Guar seems to be even more effective in alleviating the signs and symptoms of dry eye as well as affording improved ocular surface protection by decreasing tear film evaporation.
Clinical Trial: :
Ethics Committee of the university Erlangen Nuremberg, 3573
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