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A randomised, double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients
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A randomised, double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients
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A randomised, double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients
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Journal Article
A randomised, double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients
2012
Overview
Aims To compare the efficacy and safety of 3% diquafosol ophthalmic solution with those of 0.1% sodium hyaluronate ophthalmic solution in dry eye patients, using mean changes in fluorescein and rose bengal staining scores as endpoints. Trial design and methods In this multicenter, randomised, double-masked, parallel study of 286 dry eye patients with fluorescein and rose bengal staining scores of ≥3 were randomised to the treatment groups in a 1 : 1 ratio. Efficacy and safety were evaluated after drop-wise instillation of the study drug, six times daily for 4 weeks. Results After 4 weeks, the intergroup difference in the mean change from baseline in fluorescein staining score was −0.03; this verified the non-inferiority of diquafosol. The mean change from baseline in rose bengal staining score was significantly lower in the diquafosol group (p=0.010), thus verifying its superiority. The incidence of adverse events was 26.4% and 18.9% in the diquafosol and sodium hyaluronate groups, respectively, with no significant difference. Conclusions Diquafosol (3%) and sodium hyaluronate (0.1%) exhibit similar efficacy in improving fluorescein staining scores of dry eye patients, whereas, diquafosol exhibits superior efficacy in improving rose bengal staining scores. Diquafosol has high clinical efficacy and is well tolerated with a good safety profile.
Publisher
BMJ Publishing Group Ltd,BMJ Publishing Group,BMJ Publishing Group LTD,BMJ Group
Subject
/ Biological and medical sciences
/ Cornea
/ Disease
/ Drugs
/ Dry Eye Syndromes - drug therapy
/ Dry Eye Syndromes - pathology
/ Glaucoma
/ Humans
/ Hyaluronic Acid - administration & dosage
/ Hyaluronic Acid - adverse effects
/ Ophthalmic Solutions - administration & dosage
/ Ophthalmic Solutions - adverse effects
/ Original
/ Polyphosphates - administration & dosage
/ Polyphosphates - adverse effects
/ Quality
/ Sodium
/ Tears
/ Uracil Nucleotides - administration & dosage
/ Uracil Nucleotides - adverse effects
