Tear volume estimation using a modified Schirmer test: a randomized, multicenter, double-blind trial comparing 3% diquafosol ophthalmic solution and artificial tears in dry eye patients

Hideki Miyake, Yuri Kawano, Hiroshi Tanaka, Akihiro Iwata, Takahiro Imanaka, Masatsugu Nakamura, Hideki Miyake, Yuri Kawano, Hiroshi Tanaka, Akihiro Iwata, Takahiro Imanaka, Masatsugu Nakamura

Abstract

Purpose: We aimed to evaluate the feasibility of using a modified Schirmer test to determine the increase in tear volume after administration of 3% diquafosol ophthalmic solution (diquafosol 3%) in dry eye patients.

Patients and methods: A randomized, multicenter, prospective, double-blind clinical study recruited 50 qualified subjects. They received diquafosol 3% in one eye and artificial tears in the other eye. The study protocol comprised a screening and treatment procedure completed within 1 day. The Schirmer test was performed on closed eyes three times a day. The primary efficacy end points were the second Schirmer test scores 10 minutes after the single dose. Secondary end points were the third Schirmer test scores 3 hours and 40 minutes after the single dose and the symptom scores prior to the second and third Schirmer tests.

Results: According to the Schirmer test, 10 minutes after administration, diquafosol 3% significantly increased tear volume compared to artificial tears. Diquafosol 3% and artificial tears both showed significant improvements in the symptom scores compared to baseline. However, there was no significant difference in the symptoms score between diquafosol 3% and artificial tears.

Conclusion: The modified Schirmer test can detect a minute change in tear volume in dry eye patients. These findings will be useful in the diagnosis of dry eye, assessment of treatment benefits in daily clinical practice, and the development of possible tear-secreting compounds for dry eye.

Keywords: Diquas®; P2Y2; efficacy.

Figures

Figure 1
Figure 1
Study design. Notes: The study protocol was a randomized, multicenter, double-blind, right-eye and left-eye comparison clinical study. The screening and treatment periods occurred on the same day.
Figure 2
Figure 2
Change in tear secretion from baseline. Notes:*P=0.024 for diquafosol 3% vs artificial tear, paired t-test. Each point shows the mean ± standard error.

References

    1. Versura P, Bavelloni A, Grillini M, Fresina M, Campos EC. Diagnostic performance of a tear protein panel in early dry eye. Mol Vis. 2013;19:1247–1257.
    1. Koh S. Clinical utility of 3% diquafosol ophthalmic solution in the treatment of dry eyes. Clin Ophthalmol. 2015;9:865–872.
    1. Schirmer O. Studien zur Phisiologie und Pathologie der Traenenab-sonderung und Traenenabfuhr [Studies on physiology and pathology of the tear secretion and outflow] Graefes Arch Klin Exp Ophthalmol. 1903;56:197–291. German.
    1. Alves M, Fonseca EC, Alves MF, et al. Dry eye disease treatment: a systematic review of published trials and a critical appraisal of therapeutic strategies. Ocul Surf. 2013;11(3):181–192.
    1. The definition and classification of dry eye disease: report of the Definition and Classification Subcommittee of the International Dry Eye Workshop (2007) Ocul Surf. 2007;5(2):75–92. No authors listed.
    1. Shimazaki J. Definition and diagnosis of dry eye 2006. Atarashii Ganka. 2007;24:181–184.
    1. Serruya LG, Nogueira DC, Hida RY. Schirmer test performed with open and closed eyes: variations in normal individuals. Arq Bras Oftalmol. 2009;72(1):65–67.
    1. Kashkouli MB, Pakdel F, Amani A, Asefi M, Aghai GH, Falavarjani KG. A modified Schirmer test in dry eye and normal subjects: open versus closed eye and 1-minute versus 5-minute tests. Cornea. 2010;29(4):384–387.
    1. Bitton E, Wittich W. Influence of eye position on the Schirmer tear test. Cont Lens Anterior Eye. 2014;37(4):257–261.
    1. Bawazeer AM, Hodge WG. One-minute Schirmer test with anesthesia. Cornea. 2003;22(4):285–287.
    1. Li N, Deng X-G, He M-F. Comparison of the Schirmer I test with and without topical anesthesia for diagnosing dry eye. Int J Ophthalmol. 2012;5(4):478–481.
    1. Savini G, Barboni P, Zanini M. Tear meniscus evaluation by optical coherence tomography. Ophthalmic Surg Lasers Imaging. 2006;37(2):112–118.
    1. Wang J, Palakuru JR, Aquavella JV. Correlations among upper and lower tear menisci, non-invasive tear break-up time and Schirmer’s test. Am J Ophthalmol. 2008;145(5):795–800.
    1. Yokoi N, Bron AJ, Tiffany JM, Kinoshita S. Reflective meniscometry: a new field of dry eye assessment. Cornea. 2000;19(3 Suppl):S37–S43.
    1. Bandlitz S, Purslow C, Murphy PJ, Pult H. Comparison of a new portable digital meniscometer and optical coherence tomography in tear meniscus radius measurement. Acta Ophthalmol. 2014;92(2):e112–e118.
    1. Ibrahim OM, Dogru M, Ward SK, et al. The efficacy, sensitivity, and specificity of strip meniscometry in conjunction with tear function tests in the assessment of tear meniscus. Invest Ophthalmol Vis Sci. 2011;52(5):2194–2198.
    1. Koh S, Ikeda C, Takai Y, Watanabe H, Maeda N, Nishida K. Long-term results of treatment with diquafosol ophthalmic solution for aqueous-deficient dry eye. Jpn J Ophthalmol. 2013;57(5):440–446.
    1. Yokoi N, Kato H, Kinoshita S. Facilitation of tear fluid secretion by 3% diquafosol ophthalmic solution in normal human eyes. Am J Ophthalmol. 2014;157(1):85–92.e1.
    1. Yokoi N, Sonomura Y, Kato H, Komuro A, Kinoshita S. Three percent diquafosol ophthalmic solution as an additional therapy to existing artificial tears with steroids for dry-eye patients with Sjögren’s syndrome. Eye. 2015;29(9):1204–1212.
    1. Shigeyasu C, Hirano S, Akune Y, Yamada M. Diquafosol tetrasodium increases the concentration of mucin-like substances in tears of healthy human subjects. Curr Eye Res. 2015;40(9):878–883.
    1. Matsumoto Y, Ohashi Y, Watanabe H, Tsubota K. Efficacy and safety of diquafosol ophthalmic solution in patients with dry eye syndrome: a Japanese phase 2 clinical trial. Ophthalmology. 2012;119(10):1954–1960.
    1. Mundasad MV, Novack GD, Allgood VE, Evans RM, Gorden JC, Yerxa BR. Ocular safety of INS365 ophthalmic solution: a P2Y(2) agonist in healthy subjects. J Ocul Pharmacol Ther. 2001;17(2):173–179.
    1. Methodologies to diagnose and monitor dry eye disease: report of the Diagnostic Methodology Subcommittee of the International Dry Eye WorkShop (2007) Ocul Surf. 2007;5(2):108–152.
    1. Shen M, Wang J, Tao A, et al. Diurnal variation of upper and lower tear menisci. Am J Ophthalmol. 2008;145(5):801–806.
    1. Akiyama-Fukuda R, Usui T, Yoshida T, Yamagami S. Evaluation of tear meniscus dynamics using anterior segment swept-source optical coherence tomography after topical solution instillation for dry eye. Cornea. 2016;35(5):654–658.
    1. Takaoka-Shichijo Y, Murakami T, Nakamura M. Stimulatory effect of diquafosol tetrasodium on tear fluid secretion in normal rabbits. J Eye. 2011;28(7):1029–1033. Japanese.

Source: PubMed

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