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 only.
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.
BACKGROUND: The ocular surface changes of keratoconjunctivitis sicca (KCS) could be the result of the effect of an altered tear film on the epithelial environment.
PURPOSE: To evaluate the possibility of improving the environmental conditions of the ocular surface by lowering tear osmolarity, increasing tear film volume and stabilising the tear film. Also, to study the effect of such an improvement on the epithelial cells of the ocular surface.
METHODS: One hundred and thirty-five patients with a diagnosis of KCS were treated on a randomised basis with either unpreserved hypotonic 0.4% hyaluronic acid (HHA) eye drops or 0.3% hydroxypropylmethylcellulose plus 0.1% Dextran 70 (HPMC) eye drops 6 times a day for 60 or 90 days. In all patients a Schirmer I test, break-up time (BUT), ocular surface staining with 1% Bengal Rose, or 2% fluorescein, as well as subjective symptoms, were recorded before and 15, 30 and 60 days after the beginning of the study. Patients were divided into three subgroups and the effect of the treatment was studied using three different techniques: the tear ferning test, conjunctival impression cytology and tear osmolarity measurement.
RESULTS: Improvements in BUT, vital staining, Schirmer I and symptoms were recorded in both groups of treatment, with significant differences for patients treated with 0.4% HHA. On day 60, 30 min after installation: tear ferning patterns changed from 100% pathological (types III-IV) to 93% physiological (types I-II) in the 0.4% HHA group and from 100% pathological to 78% physiological in the 0.3% HPMC group (p < 0.01 between groups). Tear osmolarity shifted from 353 +/- 23 to 305 +/- 6 mosmol/l in the 0.4% HHA group and from 346 +/- 15 to 336 +/- 8 mosmol/l in the 0.3% HPMC group (p < 0.001 between groups). On day 90, the impression cytology score improved from 1.2 to 1.9 in the 0.4% HHA group while it did not change in the 0.3% HPMC group (p < 0.05 between groups).
CONCLUSION: In KCS appropriate treatment with a hypotonic 0.4% HHA tear substitute can change the tear environment and results in improvement of the epithelial conditions of the ocular surface.
BACKGROUND/AIMS: Hyaluronan (sodium hyaluronate) has been shown to confer objective and subjective improvement in patients with dry eye syndrome. This study compared the efficacy and safety of a 0.1% solution of hyaluronan with 0.9% saline, when administered topically to the eye, in the treatment of symptoms of severe dry eye syndrome.
METHODS: A randomised, double blind, crossover clinical trial in which subjects were randomised to receive either hyaluronan or saline, applied as one or two drops to the eye, three or four times a day or as required. After 28 days' treatment, subjects crossed over to the other study medication for a further 28 days' treatment.
RESULTS: 70 subjects were included in the analyses of efficacy and significant improvements in Schirmer's score (p=0.0006) and rose bengal staining score (p=0.0001) were observed during treatment with hyaluronan. In a subjective assessment of the effectiveness of two treatments, a majority of subjects felt that hyaluronan was more effective than saline in alleviating the symptoms of burning and grittiness (p<0.001). No adverse events attributable to hyaluronan treatment were reported.
CONCLUSION: The study demonstrates a clear benefit of hyaluronan over saline, in both subjective and objective assessments of dry eye syndrome. Hyaluronan was shown to be well tolerated.
