SODIUM HYALURONATE EYE DROPS IN THE TREATMENT OF DRY EYE DISEASE: AN OPEN LABEL, UNCONTROLLED, MULTI-CENTRE TRIAL
AbstractBackground: Dry eye disease (DED) is one of the most frequently encountered ocular morbidities.The objective of this study was to assess the performance of sodium hyaluronate eye drop for eightweeks in patients with DED. Patients and Methods: This was a multi-centre, open-label,uncontrolled clinical trial carried out at different centres of Pakistan, from August 2009 to November2010. A total of 250 diagnosed patients of Dry Eye who met the inclusion criteria were included inthe study. After informed written consent, all patients having at least 2 of the Dry Eye symptoms,and at least 1 of the tests (Tear Film Break-up time (TBUT) ≤10 second, Schirmer’s test ≤6 mm/5min, and positive corneal staining) were enrolled. Tolerability/safety assessments consisted ofmonitoring and recording of adverse events and physical examinations at baseline, 4th week and 8thweek. Results: Out of 250 allocated patients 13 dropped out. The mean age of the patients was47.6±13.8 year and out of 237 patients 86 (36.3%) were men and 151 (63.7%) were women. At theinitial visit the foreign body sensation was 80%, itching 68%, burning 58%, watering 38%,photophobia 38%, and feeling of dryness was 16%. At the 3rd visit the foreign body sensationdecreased to 32%, itching to 32%, burning to 20%, watering to 12%, photophobia to 18%, andfeeling of dryness to 14%. Conclusion: Sodium hyaluronate has a beneficial effect on theconjunctival epithelium in a well-defined and homogeneous population of patients with dry eye andcan be considered useful for the treatment of dry eye.Keywords: Fluoresce in eye stain, Tear Break up Time, Schirmer’s test, Dry Eye Disease
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