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

ABSTRACT

To assess the effectiveness of sodium hyaluronate Eye Gel in Dry Eye Disease [DED] patients. 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] 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. 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. Sodium Hyaluronate can provide a suitable alternate in the treatment of dry eye disease due to its reported efficacy on foreign body sensation, itching, burning, watering, photophobia and feeling of dryness