Long-Term Safety and Effectiveness of Diquafosol for the Treatment of Dry Eye in a Real-World Setting: A Prospective Observational Study

Yuichi Ohashi, Masahiro Munesue, Jun Shimazaki, Etsuko Takamura, Norihiko Yokoi, Hitoshi Watanabe, Akio Nomura, Fumiki Shimada, Yuichi Ohashi, Masahiro Munesue, Jun Shimazaki, Etsuko Takamura, Norihiko Yokoi, Hitoshi Watanabe, Akio Nomura, Fumiki Shimada

Abstract

Introduction: Diquafosol is a P2Y2 receptor agonist that has been shown to be effective in the treatment of dry eye disease (DED) in short-term studies; however, its long-term safety and effectiveness have not been evaluated in a real-world setting.

Methods: This prospective, multicentre, open-label observational study was conducted in patients with DED over 12 months. Safety endpoints included the incidence of adverse drug reactions (ADRs) and serious ADRs. Effectiveness endpoints included change from baseline in keratoconjunctival staining score, tear film break-up time (BUT) and Dry Eye-related Quality of Life Score (DEQS).

Results: A total of 580 patients were included, most of whom were female (82.9%). The proportion of patients who completed 12 months of observation was 55.0%, the most common reason for discontinuation was patient decision (54.6%). The incidence of ADRs was 10.7% and was highest during the first month of treatment (5.5%); no serious ADRs were reported. Compared with baseline, significant improvements in all effectiveness outcomes, including keratoconjunctival fluorescein staining score, BUT and DEQS summary score, were observed at each evaluation during the treatment period (p < 0.001).

Conclusion: The present, real-world study showed that diquafosol 3.0% ophthalmic solution was well tolerated and effective in the long-term treatment of DED.

Keywords: Break-up time; Diquafosol; Dry eye; Fluorescein staining; Ophthalmology; Post-marketing study; Safety.

Figures

Fig. 1
Fig. 1
Patient flow diagram
Fig. 2
Fig. 2
Mean change in a fluorescein staining score and b tear film break-up time. Error bars represent standard deviation. *p < 0.001, versus baseline determined using paired t test
Fig. 3
Fig. 3
Mean change in the Dry Eye-related Quality of Life Score (DEQS). Error bars represent standard deviation. *p < 0.001, versus baseline determined using paired t test

References

    1. Farrand KF, Fridman M, Stillman IO, Schaumberg DA. Prevalence of diagnosed dry eye disease in the United States among adults aged 18 years and older. Am J Ophthalmol. 2017;182:90–98. doi: 10.1016/j.ajo.2017.06.033.
    1. Uchino M, Yokoi N, Uchino Y, et al. Prevalence of dry eye disease and its risk factors in visual display terminal users: the Osaka study. Am J Ophthalmol. 2013;156(4):759–766. doi: 10.1016/j.ajo.2013.05.040.
    1. Shimazaki J. Definition and diagnostic criteria of dry eye disease: historical overview and future directions. Invest Ophthalmol Vis Sci. 2018;59(14):7–12. doi: 10.1167/iovs.17-23475.
    1. Craig JP, Nichols KK, Akpek EK, et al. TFOS DEWS II definition and classification report. Ocul Surf. 2017;15(3):276–283. doi: 10.1016/j.jtos.2017.05.008.
    1. Tsubota K, Yokoi N, Shimazaki J, et al. New perspectives on dry eye definition and diagnosis: a consensus report by the Asia Dry Eye Society. Ocul Surf. 2017;15(1):65–76. doi: 10.1016/j.jtos.2016.09.003.
    1. Revised definition and diagnosis criteria of dry eye in Japan, 2016 [database on the Internet]. . Accessed Feb 22 2019.
    1. Shimazaki J. Diagnosis criteria of dry eye. Atarashii Ganka. 2007;24(2):181–184.
    1. Begley CG, Chalmers RL, Abetz L, et al. The relationship between habitual patient-reported symptoms and clinical signs among patients with dry eye of varying severity. Invest Ophthalmol Vis Sci. 2003;44(11):4753–4761. doi: 10.1167/iovs.03-0270.
    1. Mizuno Y, Yamada M, Miyake Y. Association between clinical diagnostic tests and health-related quality of life surveys in patients with dry eye syndrome. Jpn J Ophthalmol. 2010;54(4):259–265. doi: 10.1007/s10384-010-0812-2.
    1. Wolffsohn JS, Arita R, Chalmers R, et al. TFOS DEWS II diagnostic methodology report. Ocul Surf. 2017;15(3):539–574. doi: 10.1016/j.jtos.2017.05.001.
    1. Yokoi N, Uchino M, Uchino Y, et al. Importance of tear film instability in dry eye disease in office workers using visual display terminals: the Osaka study. Am J Ophthalmol. 2015;159(4):748–754. doi: 10.1016/j.ajo.2014.12.019.
    1. Takamura E, Tsubota K, Watanabe H, Ohashi Y. A randomised, double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients. Br J Ophthalmol. 2012;96(10):1310–1315. doi: 10.1136/bjophthalmol-2011-301448.
    1. Drug profile: diquafosol—Merck/Santen pharmaceutical. [database on the Internet]. Adis International Ltd., part of Springer Science + Business Media 2019. . Accessed Mar 14 2019.
    1. Yamaguchi M, Nishijima T, Shimazaki J, et al. Clinical usefulness of diquafosol for real-world dry eye patients: a prospective, open-label, non-interventional, observational study. Adv Ther. 2014;31(11):1169–1181. doi: 10.1007/s12325-014-0162-4.
    1. Sakane Y, Yamaguchi M, Yokoi N, et al. Development and validation of the Dry Eye-related Quality-of-Life Score questionnaire. JAMA Ophthalmol. 2013;131(10):1331–1338. doi: 10.1001/jamaophthalmol.2013.4503.
    1. Drug and Therapeutics Bulletin The management of dry eye. BMJ. 2016;353:i2333.
    1. Berger ML, Dreyer N, Anderson F, Towse A, Sedrakyan A, Normand SL. Prospective observational studies to assess comparative effectiveness: the ISPOR good research practices task force report. Value Health. 2012;15(2):217–230. doi: 10.1016/j.jval.2011.12.010.
    1. Mann CJ. Observational research methods. Research design II: cohort, cross sectional, and case-control studies. Emerg Med J. 2003;20(1):54–60. doi: 10.1136/emj.20.1.54.

Source: PubMed

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