Effectiveness of sodium hyaluronate eye gel in patients with dry eye disease: A multi-centre, open label, uncontrolled study

To assess the effectiveness of sodium hyaluronate Eye Gel in Dry Eye Disease (DED) patients Methods: A Multi-center, Open-label, Uncontrolled clinical trial was conducted in different centers of Pakistan. Ten ophthalmologists conducted this study in which 250 diagnosed patients with dry eye disease were enrolled after obtaining a written informed consent. Ten patients were dropped out during the study period. All patients were assessed as per following criteria for enrolling a patient into the study: Tear Film Break - up time (TBUT) ≤ 10 seconds, Schirmer Test - 1 ≤ 6 mm / 5 minutes and Positive Corneal Staining. Tolerability/safety was assessed by the monitoring and recording of all adverse events. The physical examination was done at baseline, 4(th) week and 8(th) week. Results : The mean age of the patients was 43.4 ±17.8 years and out of 240 patients 117 (48.7%) were males and 123 (51.3%) females. The Mean duration of symptoms was 19.3±23.9. At the initial visit the foreign body sensation was 50.6%, itching 35.9%, burning 50.6%, watering 42.9%, photophobia 25.3% and feeling of dryness in 14.7% of patients. After 4 weeks (2(nd) visit), the symptoms were decreased to 47.1% foreign body sensation, 32.4% itching, 48.2% burning, 41.8% watering, 25.3% photophobia and 13.5% feeling of dryness. At the 3(rd) visit (after 8 weeks) the frequency of symptoms were: 45.3% foreign body sensation, 30.6% itching, 45.9% burning, 40% watering, 24.7% photophobia and 13.5% feeling of dryness.