Efficacy of 0.01% dexamethasone solution in comprehensive therapy of dry eye disease

Cover Page


Introduction. The officinal dosage of dexamethasone solution (0.1%) has a marked localized antiinflammatory effect. But the widespread use of this dose in the management of dry eye diseases is limited by the risk of damage to the cornea. Therefore, the authors developed a solution containing 0.01% dexamethasone phosphate in combination with 6% polyvinylpyrolidone and 1.5%–5.5% dextrose [3]. 
Aim. To study the effects of this novel anti-inflammatory solution on corneal inflammatory processes. 

Materials and methods. This study included a cohort of 25 patients (50 eyes) with corneal–conjunctival xerosis. Lower tear meniscus index, precorneal tear film production, stability and osmolarity, and the degree of staining of the ocular surface epithelium with vital solutions were assessed prior to the treatment and on day 28 of the study. The presence of the cytokines IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-1Ra, TNF-α, INF-α, and INF-γ in patients’ tear fluid and blood plasma was quantified using ELISA. 
All patients were asked to complete a questionnaire to evaluate subjective signs of xerosis of the ocular surface. 

Results. Statistically significant increases in tear meniscus index, precorneal tear film stability, and main and total tear production, with a significant decrease in tear film osmolarity were observed by day 28 of the study. In addition, positive changes in objective parameters relating to the ocular surface epithelium were further confirmed by the patients’ evaluations of their quality of life. Furthermore, the degree of staining of the ocular surface epithelium with vital solutions also decreased. 

Conclusions. The results of the study demonstrate the high level of effectiveness of the developed medication as a treatment for dry eye diseases of various etiologies.

Vladimir V. Brzheskiy

Saint Petersburg State Medical Pediatric University

Author for correspondence.
Email: vvbrzh@yandex.ru

Russian Federation PhD, professor, Head of Department of ophthalmology and clinical pharmacology

Vladimir Yu. Popov

Saint Petersburg State Medical Pediatric University

Email: popovvladimir221122@gmail.com

Russian Federation research fellow

Irina V. Kalinina

Mariinsky Hospital

Email: irbrg@yandex.ru

Russian Federation ophthalmologist

Natalia M. Kalinina

Nikiforov Russian Centre of Emergency and Radiation Medicine

Email: medicine@arcerm.spb.ru

Russian Federation PhD, professor, chief research associate

Liudmila V. Chenenova

Nikiforov Russian Centre of Emergency and Radiation Medicine

Email: medicine@arcerm.spb.ru

Russian Federation laboratory technician

  1. Белямова А.Ф., Бржеский В.В., Калинина Н.М., и др. Методические подходы к сбору материала для исследования параметров местного иммунитета при синдроме «сухого глаза» // Медицинская иммунология. – 2009. – Т. 11. – № 4–5. – С. 470–471. [Belyamova AF, Brzheskiy VV, Kalinina NM, et al. Methodological approaches to the collection of material for the study of the parameters of local immunity in the dry eye disease (DED). Medical Immunology. 2009;11(4-5):
  2. -71. (In Russ).]
  3. Бржеский В.В., Егорова Г.Б., Егоров Е.А. Синдром «сухого глаза» и заболевания глазной поверхности: клиника, диагностика, лечение. – М.: ГЕОТАР-медиа, 2016. [Brzheskiy VV, Egorova GB, Egorov EA. The dry eye disease and ocular surface disease: clinical features, diagnosis, treatment. Moscow: GEOTAR-Media Publishing House; 2016. (In Russ).]
  4. Бржеский В.В., Садовникова Н.Н., Прозорная Л.П., Попов В.Ю. Препарат для лечения синдрома «сухого глаза». Патент на изобретение RU2559580 № 2014110290; заявл. 18.03.2014; опубл. 10.08.2015, Бюл. № 22. [Brzheskiy VV, Sadovnikova NN, Prozornay LP, Popov VYu. The medicine for treatment of dry eye disease. Russian Federation Patent 2559580. 2015. (In Russ).]
  5. Егоров Е.А., Алексеев В.Н., Астахов Ю.С. Рациональная фармакотерапия в офтальмологии. – М.: Литтерра, 2004. [Egorov EA, Alekseev VN, Astakhov YuS. Rational pharmacotherapy in ophthalmology. Moscow: Litterra Publishing House; 2004. (In Russ).]
  6. Aragona P, Spinella R, Rania L, et al. Safety and efficacy of 0.1 % clobetasone butyrate eyedrops in the treatment of dry eye in Sjögren syndrome. Eur J Ophthalmol. 2013;23:368-76. doi: 10.5301/ejo.5000229.
  7. Avunduk AM, Avunduk MC, Varnell ED, et al. The comparison of efficacies of topical corticosteroids and nonsteroidal anti-inflammatory drops on dry eye patients: a clinical and immunocytochemical study. Am J Ophthalmol. 2003;136:593-602. doi: 10.1016/S0002–9394(03)00326-X.
  8. Dana MR, Hamrah P. Role of immunity and inflammation in corneal and ocular surface associated with dry eye. Adv Exp Med Biol. 2002;506:729-38. doi: 10.1007/978-1-4615-0717-8_1.
  9. De Paiva CS, Corrales RM, Villarreal AL, et al. Corticosteroid and doxycycline suppress MMP-9 and inflammatory cytokine expression, MAPK activation in the corneal epithelium in experimental dry eye. Exp Eye Res. 2006;83:526-35. doi: 10.1016/j.exer.2006.02.004.
  10. Djalilian AR, Nagineni CN, Mahesh SP, et al. Inhibition of inflammatory cytokine production in human corneal cells by dexamethasone, but not cyclosporin. Cornea. 2006;25(6):709-14. doi: 10.1097/01.ico.0000208815.02120.90.
  11. Eagle RC, Donoso LA, Laibson PR. Mucosa specific lymphocytes in the human conjunctiva, corneoscleral limbus and lacrimal gland. Curr Eye Res. 1994;13:87-93.
  12. Eliason JA, Maurice DM. Staining of the conjunctiva and conjunctival tear film. Brit J Ophthalmol. 1990;74(9):519-22. doi: 10.1136/bjo.74.9.519.
  13. Feenstra RP, Tseng SCG. Comparison of fluorescein and rose bengal staining. Ophthalmology. 1992;99(4):605-17. doi: 10.1016/S0161–6420(92)31947–5.
  14. Höh H, Schwanengel M. Rückbildung der lidkantenparallelenkonjunktivalenFalten (LIPCOF) unter Lokal therapie mit Liposic-Augengel — Eine Pilotstudie. Klin Monbl Augenheilkd. 2006;223(21):918-23. doi: 10.1055/s-2006-927103.
  15. Jones LT. The lacrimal secretory system and its treatment. Am J Ophthalmol. 1966;62(1):47-60. doi: 10.1016/0002-9394(66)91676-X.
  16. Jung HH, Ji YS, Sung MS, et al. Long-Term outcome of treatment with topical corticosteroids for severe dry eye associated with Sjogren’s syndrome. Chonnam Med J. 2015;51(1):26-32. doi: 10.4068/cmj.2015.51.1.26.
  17. Knop N, Knop E. Conjunctiva-associated lymphoid tissue in the human eye. Invest Ophthalmol Vis Sci. 2000;41:1270-79.
  18. Lee JH, Min K, Kim SK, et al. Inflammatory cytokine and osmolarity changes in the tears of dry eye patients treated with topical 1 % methylprednisolone. Yonsei Med J. 2014;55(1):203-8. doi: 10.3349/ymj.2014.55.1.203.
  19. Marsh P, Pflugfelder SC. Topical nonpreserved methylprednisolone therapy for keratoconjunctivitis sicca in Sjogren syndrome. Ophthalmology. 1999;106:811-16.
  20. Norn MS. Desiccation of the precorneal film. I. Corneal wetting time. Acta Ophthalmol. 1969;47(4):865-80. doi: 10.1111/j.1755-3768.1969.tb03711.x.
  21. Pflugfelder SC, Maskin SL, Anderson B, et al. A randomized, double-masked, placebo-controlled, multicenter comparison of loteprednol etabonate ophthalmic suspension, 0.5 %, and placebo for treatment of keratoconjunctivitis sicca in patients with delayed tear clearance. Am J Ophthalmol. 2004;138 (3):444-57. doi: 10.1016/j.ajo.2004.04.052.
  22. Schiffman RM, Christianson MD, Jacobsen G, et al. Reliability and validity of the Ocular Surface Disease Index. Arch Ophthalmol. 2000;118(5):615-21. doi: 10.1001/archopht.118.5.615.
  23. Schirmer O. Studie zur Physiologie und Pathologie der Traenenabsonderung und Traenenabfuhr. Albrecht v Graefes Arch Ophthalmol. 1903;56(2):197-291. doi: 10.1007/BF01946264.
  24. Sheppard JD, Scoper SV, Samudre S. Topical loteprednol pretreatment reduces cyclosporine stinging in chronic dry eye disease. J Ocul Pharmacol Ther. 2011;27(1):23-27. doi: 10.1089/jop.2010.0085.


Abstract - 1231

PDF (Russian) - 269


Comments on this article

View all comments

Copyright (c) 2016 Brzheskiy V.V., Popov V.Y., Kalinina I.V., Kalinina N.M., Chenenova L.V.

Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 International License.