title: Effectiveness of sodium hyaluronate eye gel in patients with dry eye disease: a multi-centre, open label, uncontrolled study.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Dr. Prof. Nasir Saeed, Head Department of Ophthalmology, Hayat Abad Medical Complex Peshawar, Pakistan.
authors.forename: Nasir
authors.initials: N
authors.lastname: Saeed
authors.affiliation: Dr. ZA Qazi, LRBT Hospital, Township, Lahore, Pakistan.
authors.forename: Za
authors.initials: Z
authors.lastname: Qazi
authors.affiliation: Dr. Nadeem H Butt, Department of Ophthalmology, Jinnah Hospital, Lahore, Pakistan.
authors.forename: Nadeem
authors.initials: N
authors.lastname: H Butt
authors.affiliation: Dr. Ahson Siddiqi, Head Medical & Regulatory Affairs, 15 West wharf Road, Novartis Pharma Pakistan, Karachi, Pakistan.
authors.forename: Ahson
authors.initials: A
authors.lastname: Siddiqi
authors.affiliation: Dr. Neeta Maheshwary, Medical Scientific Liaison, 15 West wharf Road, Novartis Pharma Pakistan, Karachi, Pakistan.
authors.forename: Neeta
authors.initials: N
authors.lastname: Maheshwary
authors.affiliation: Dr. Muhammad Athar Khan, Lecturer, Department of Medical Education, King Saud bin Abdulaziz University, Riyadh, Kingdom of Saudi Arabia.
authors.forename: Muhammad
authors.initials: M
authors.lastname: Athar Khan
keywords: Fluorescein eye stain; Schirmer's test; Tear Film Break up Time