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R. Brazzell, D. J. Kellerman, A. Schaberg, B. Yerxa, T. Durham; Effect of Diquafosol on Ocular Surface Health in Dry Eye Disease. Invest. Ophthalmol. Vis. Sci. 2007;48(13):380.
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To study the effect of diquafosol, a potent and selective P2Y2 agonist, on ocular surface health in patients with dry eye disease.
Diquafosol was studied in seven clinical trials in over 2000 dry eye patients. In these trials, the drug was administered topically four times a day for durations ranging from one day to one year.
These trials have demonstrated statistically significant improvements in various measures of ocular surface health, including corneal staining, central corneal staining, conjunctival staining, clearance of corneal staining and clearance of central corneal staining. In 2 Phase III trials, patients treated with diquafosol demonstrated statistically significantly lower (p≤0.001) mean corneal staining scores and statistically significantly lower (p≤0.05) mean conjunctival staining scores compared to patients treated with placebo after 6 weeks of QID dosing. A statistically significantly (p≤0.05) higher proportion of patients treated with diquafosol achieved a total corneal staining score of zero compared to placebo after 4 or 6 weeks of QID dosing in two Phase III trials - in these trials treated patients were 3 to 4 times more likely to have a corneal staining score of zero compared to placebo-treated patients. In 2 Phase III trials, patients treated with diquafosol were statistically significantly (p≤0.05) more likely to have a zero staining score in the central region of the cornea after 6 weeks of treatment compared to patients treated with placebo, with near statistical significance achieved in a third trial (p=0.052). Analysis of combined data from several of the trials demonstrated that dry eye patients with central corneal staining have statistically significantly worse best corrected visual acuity and other signs and symptoms of dry eye than dry eye patients with no staining in the central region of the cornea.
The collective body of clinical data suggests that diquafosol has positive effects on ocular surface health in patients with dry eye disease that represent clinically meaningful improvements.
www.clinicaltrials.gov NCT00403975, NCT00403715, NCT00404131
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