Background  

Sodium hyaluronate (SH) is used in patients with dry eye. We evaluated the efficacy and safety of SH and carboxymethylcellulose (CMC) in the treatment of dry eye syndrome with superficial keratitis.

Methods  

A total of 22 patients with moderate dry eye and superficial keratitis were enrolled in a prospective, randomised, masked-observer, parallel-group, single-centre study. Patients were randomly assigned to a 0.18% SH or 1% CMC solution for a 2-month period. In addition to the commonly assessed parameters in patients with dry eye (among others symptoms and corneal staining with fluorescein), flow cytometry analysis of CD44, HLA DR expressions in impression cytology was investigated as a potential efficacy parameter.

Results  

Both treatments improved the symptoms and ocular surface and were well tolerated. SH significantly (p<0.05) decreased="" cd44="" values="" compared="" with="" cmc.="" comfort="" was="" significantly="">P<0.05) better="" in="" the="" sh="" group="" than="" that="" in="" the="" cmc="" group="" throughout="" the="" study.="" recovery="" in="" keratitis="" (type,="" extent="" and="" depth)="" and="" symptoms="" were="" faster="" in="" the="" sh="" group="" than="" in="" the="" cmc="" group.="" blurred="" vision="" was="" reported="" by="" patients="" in="" the="" cmc="" group="">

Conclusions  

SH was well tolerated and tended to show a faster efficacy than did the CMC-based formulation in patients with moderate dry eye and superficial keratitis. SH could therefore advantageously be prescribed from the early stages of dry eye disease. This study also showed that flow cytometry in impression cytology specimens is a reliable tool for exploring the ocular surface at the epithelial level and that CD44, in addition to HLA DR, could be an interesting endpoint for future trials in dry eye syndrome with products based on SH.