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A.O. Climent; Comparison of GenAqua®–Preserved Genteal® in Multidose Bottles vs Preservative–Free Tears Naturale® in Single Dose Units in Patients With Moderate to Severe Dry Eye . Invest. Ophthalmol. Vis. Sci. 2006;47(13):261.
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© ARVO (1962-2015); The Authors (2016-present)
To compare the efficacy, tolerability and convenience of use of a GenAqua® (sodium perborate)–preserved lubricant (GenTeal®, Novartis Ophthalmics) with an unpreserved product in single dose units (Tears Naturale® SDU, Alcon) in patients with moderate to severe dry eye.
Single–center, randomized, open–label, two–treatment two period crossover study. Eligible patients were randomized to two treatment sequences of 4 weeks each (GenTeal followed by Tears Naturale SDU, or Tears Naturale SDU followed by GenTeal). Signs (Schirmer, TBUT, corneal staining) and symptoms (tired eyes, dryness, foreign body sensation, burning) of dry eye were assessed at the beginning and at the end of each treatment period, when tolerability and convenience of use were evaluated too
Thirty–seven patients (28F, 9M) between 22 and 74 years of age (49.8±.14.1 years) completed the study. The number of assessments showing typical signs of dry eye (Schirmer <5mm/5min, TBUT >10 seconds, erosions affecting more than 25% of surface) deccreased from 65 at the beginning to 57 at the end of treatment with GenTeal, whereas no net change was seen with Tears Naturale SDU (60 at the beginning and at the end). This difference in favor of GenTeal was statistically significant (P=0.027). No significant between–treatment differences were found for the effects on dry eye symptoms. Tolerability and convenience of use of both treatments were rated excellent or good by the vast majority of patients, with no significant differences between groups.
GenTeal was significantly superior to Tears Naturale SDU in improving clinical signs of dry eye. GenTeal with its self–disappearing GenAqua preservative system offers an equally well tolerated and safe multidose alternative to unpreserved Tears Naturale eye drops in single dose units.
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