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
O’Brien PD, Collum LM. Dry Eye: Diagnosis and current
treatment strategies. Curr Allergy Asthma Rep 2004;4:314–9.
International Dry Eye Workshop (DEWS). The definition and
classification of dry eye disease: report of the Definition and
Classification Subcommittee of the International Dry Eye
Workshop. Ocul Surface 2007;5:75–92.
Miljanović B, Dana R, Sullivan DA, Schaumberg DA. Impact
of dry eye syndrome on vision-related quality of life. Am J
Pflugfelder SC. Prevalence, burden, and pharmacoeconomics of
dry eye disease. Am J Manag Care 2008;14:S102–S106.
Moss SE, Klein R, Klein BE. Prevalence of and risk factors for
dry eye syndrome. Arch Ophthalmol 2000;118:1264–8.
Schaumberg DA, Sullivan DA, Buring JE, Dana MR.
Prevalence of dry eye syndrome among US women. Am J
Schaumberg DA, Sullivan DA, Dana MR. Epidemiology of dry
eye syndrome. Adv Exp Biol Med 2002;506:989–98.
Malik TA, Naqvi SAH, Shahid M. Dry eye syndrome; frequency
in adult patients attending the eye clinic in Military Hospital
Rawalpindi. Professional Med J 2009;16(1):145–58.
Nelson JD, Farris LR. Sodium hyaluronate and polyvinyl-alcohol
artificial tears preparations. A comparison in patients with keratoconjunctivitis sicca. Arch. Ophthalmol. 1988; 106:484–7.
Papa V, Aragona P, Russo S, Di Bella A, Russo P, Milazzo
G. Comparison of hypotonic and isotonic solutions containing
sodium hyaluronate on the symptomatic treatment of dry eye
patients. Ophthalmologica 2001;215:124–7.
Fukuda K, Miyamoto Y, Miyara Y. Hyaluronic acid in tear fluid
and its synthesis by corneal epithelial cells. Asia Pacific J
Troiano P, Monaco G. Effect of hypotonic 0.4% hyaluronic acid
drops in dry eye patients: a cross-over study. Cornea
;27(10):1126–30. doi: 10.1097/ICO.0b013e318180e55c.
Inoue M, Katakami C. The effect of hyaluronic acid on corneal
epithelial cell proliferation. Invest Ophthalmol Vis Sci
Nishida T, Nakamura M, Mishima H, Otori T. Hyaluronan
stimulates corneal epithelial migration. Exp Eye Res
Brignole F, Pisella PJ, Dupas B, Baeyens V, Baudouin C. Efficacy
and safety of 0.18% sodium hyaluronate in patients with moderate
dry eye syndrome and superficial keratitis. Graefes Arch Clin Exp
Sand BB, Marner K, Norn MS. Sodium hyaluronate in the
treatment of keratoconjunctivitis sicca. A double masked clinical
trial. Acta Ophthalmol (Copenh) 1989;67(2):181–3.
Stern ME, Beuerman RW, Fox RI, Gao J, Mircheff AK,
Pflugfelder SC. The pathology of dry eye: the interaction
between the ocular surface and lachrymals gland. Cornea
Snibson GR, Greaves JL, Soper ND, Tiffany JM, Wilson CG,
Bron AJ. Ocular surface residence times of artificial tears
solutions. Cornea 1992;11:288–93.
Takamura E, Tsubota K, Watanabe H, Ohashi Y A
randomised, double-masked comparison study of diquafosol
versus sodium hyaluronate ophthalmic solutions in dry eye
patients. Br J Ophthalmol 2012;96(10):1310–5. doi: