Duration 5min, Q&A 3min
Efficacy and Safety of Diquafosol Ophthalmic Solution for Dry Eye in a Prospective Observational Post-Marketing Study in Japan
Diquafosol, a P2Y2 receptor agonist, that facilitates the secretion of mucin as well as water on the ocular surface, has been available for dry eye (DE) treatment in Japan since December 2010. In order to evaluate the efficacy and safety of diquafosol ophthalmic solution in clinical practice, a mandatory post-marketing study was conducted in accordance with the Ministry of Health, Labor and Welfare's guideline, Good Post-marketing Study Practice.
DE patients with corneal and conjunctival staining on entry and no prior experience of diquafosol, were enrolled.
This prospective, multicenter, observational, 2-month follow-up study was started in January 2011. Data of a total of 2806 DE patients from 467 sites until April 2013 were evaluated based on corneal and conjunctival staining with fluorescein, tear film breakup time (BUT), subjective symptoms, patient reported outcomes, and adverse drug reactions (ADRs).
Results and Conclusion
Mean age of the patients was 62.2±15.6 years old and 86.4% of the subjects were female. Based on diagnostic criteria of Japan for DE, 39.8% were diagnosed as definite DE and 52.2% were probable DE. Mean dose of diquafosol was 5.4±0.9 times a day and, regarding treatment, 37.3% were newly-treated diquafosol monotherapy and 35.3% were add-on therapy to sodium hyaluronate eye drops. Diquafosol showed statistically significant improvements in corneal and conjunctival staining scores, BUT, and subjective symptom scores. The corneal and conjunctival staining sum score (range: 0-15) decreased from 3.5±2.9 before diquafosol treatment to 1.5±2.0 after treatment (p < 0.001) and BUT was prolonged from 3.6±2.0 to 5.0±2.4 sec (p < 0.001). The subjective symptom sum score (range: 0-36) decreased from 7.9±5.2 to 4.3±4.5 (p < 0.001) and 76.2% of patients felt 'much better' or 'better' than before diquafosol treatment. ADRs were found in 6.0% of the patients, mainly eye irritation (0.9%), eye discharge (0.9%), eye pain (0.7%), and lacrimation (0.6%). Taken together, Diquafosol eye drop is safe and effective to improve dry eye signs and symptoms.
[ Keyword ]
Diquafosol / dry eye / post-marketing study / mucin / treatment
[ Conflict of Interest ]
[ Conflict of Interest (Potential conflict) ]
This study was funded by Santen.