Background-Several studies in the past have attempted to demonstrate t
he efficacy of sodium hyaluronate in the treatment of dry eyes. Howeve
r, results have been conflicting and a definite conclusion has not yet
been reached. This study recruited a larger group of patients and has
incorporated for the first time both fluorescein and rose bengal stai
ning in the evaluation of the epithelium. Methods-Eighteen albino rabb
it corneas were used in a basic animal study to demonstrate the effica
cy of sodium hyaluronate by comparing the effects on the rate of epith
elial healing. The optimal concentration to be used in the clinical tr
ial was determined from the results of the basic study. In the clinica
l study 104 patients with dry eye syndrome were enrolled in a double m
asked controlled clinical trial. Patients received sodium hyaluronate
drops in one eye and control medication in the other eye for 4 weeks.
Grading of subjective symptoms and clinical examinations were performe
d at 2 and 4 weeks. Results-In the animal study sodium hyaluronate at
concentrations of 0.1% and 0.5% significantly accelerated the recovery
time of iodine vapour induced corneal erosions (p< 0.01). In the clin
ical study no statistical significance was observed in the improvement
of subjective symptoms or rose bengal staining, while fluorescein sco
res significantly improved in eyes receiving sodium hyaluronate (p=0.0
001) at 4 weeks. Conclusion-Sodium hyaluronate drops applied in six da
ily doses could not be demonstrated to offer advantages over conventio
nal tear supplies in the improvement of subjective symptoms, but may p
lay a role in maintaining a healthy corneal epithelium.