Comparative analysis of efficacy and adverse effects of tacrolimus vs cyclosporine in chronic dry eye disease: a tertiary care hospital based study

Authors

  • Zeenat Fatima Department of Pharmacology, Motilal Nehru Medical College, Allahabad, Uttar Pradesh, India
  • Rakesh Chandra Chaurasia Department of Pharmacology, Motilal Nehru Medical College, Allahabad, Uttar Pradesh, India
  • Satya Prakash Singh Department of Ophthalmology, Motilal Nehru Medical College, Allahabad, Uttar Pradesh, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20184330

Keywords:

Cyclosporine, DED, Schirmer score, Tacrolimus, TBUT

Abstract

Background: Dry eye disease (DED) is the very common and underdiagnosed ocular condition affecting vision, quality of life, and the outcomes of cataract or refractive surgery. Dry eye disease (DED), either alone or in combination with other conditions, is a frequent cause of ocular irritation that leads the patients to seek ophthalmic care. Due to a wide variety of presenting symptoms, it is often unrecognized and this causes great frustration of the patient and treating physician. While these symptoms often improve with appropriate treatment, usually in majority of the cases the disease may not be curable. Aim of the study was to compare the efficacy of tacrolimus and cyclosporine in dry eye disease.

Methods: This was a single centred, 3 months prospective study. Patients with unilateral or bilateral dry eye disease and an ocular surface disease index score >12, atleast one eye with schirmer score <5mm and TBUT <10 s were enrolled in the study. The enrolled patients were randomly divided into two groups, twenty-five patients in Group 1 and twenty three patients in Group 2 completed the follow up. Group 1(n =25) who received 0.03% tacrolimus eye ointment twice daily for consecutive 3 months and Group 2 (n= 23) received 0.05% cyclosporine eye drops twice daily for consecutive 3 months the primary efficacy outcome was Schirmer score after 3 months. The secondary outcomes were TBUT and adverse effects.

Results: After 3 months, both the treatment groups showed significant improvement in mean Schirmer score (p<0.001) and mean TBUT (p <0.0001). However, on comparing both the groups, mean Schirmer score and mean TBUT, results were comparable. No patient discontinued treatment because of minor ocular adverse effects.

Conclusions: Dry eye patients demonstrated improvement in Schirmer score and TBUT after 3 months of treatment with tacrolimus 0.03% ointment and cyclosporine 0.05% eye drops.

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References

Stern ME, Beuerman RW, Fox RI, Gao J, Mircheff AK, Pflugfelder SC. The pathology of dry eye: the interaction between the ocular surface and lacrimal glands. Cornea. 1998;17:584-9.

Pflugfelder SC, Solomon A, Stern ME. The diagnosis and management of dry eye: a twenty-five-year review. Cornea. 2000;19:644-9.

Stern ME, Gao J, Siemasko KF, Beuerman RW, Pflugfelder SC. The role of the lacrimal functional unit in the pathophysiology of dry eye. Exp Eye Res. 2004;78:409-16.

Asbell PA, Stapleton FJ, Wickstrom K, Akpek EK, Aragona P, Dana R, et al. The international workshop on meibomian gland dysfunction: report of the clinical trials subcommittee. Invest Ophthalmol Vis Sci. 2011;52:2065-85.

Bron AJ, Tomlinson A, Foulks GN, Pepose JS, Baudouin C, Geerling G, et al. Rethinking dry eye disease: a perspective on clinical implications. Ocul Surf. 2014;12:S1-31.

Li DQ, Chen Z, Song XJ, Luo L, Pflugfelder SC. Stimulation of matrix metalloproteinases by hyperosmolarity via a JNK pathway in human corneal epithelial cells. Invest Ophthalmol Vis Sci. 2004;45:4302-11.

De Paiva CS, Corrales RM, Villarreal AL, Farley WJ, Li DQ, Stern ME, 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.

Zheng X, de Paiva CS, Li DQ, Farley WJ, Pflugfelder SC. Desiccating stress promotion of Th17 differentiation by ocular surface tissues through a dendritic cell-mediated pathway. Invest Ophthalmol Vis Sci. 2010;51:3083-91.

Goyal S, Chauhan SK, El Annan J, Nallasamy N, Zhang Q, Dana R. Evidence of corneal lymphangiogenesis in dry eye disease: a potential link to adaptive immunity? Arch Ophthalmol. 2010;128:819-24.

Stevenson W, Sadrai Z, Hua J, Kodati S, Huang JF, Chauhan SK, Dana R. Effects of topical Janus kinase inhibition on ocular surface inflammation and immunity. Cornea. 2014;33:177-83.

Hom MM. Use of Cyclosporine 0.05%ophthalmic emulsion for contact lens intolerant patients. Eye Contact Lens. 2006;32(2):109-11.

Sahin A, Bozkurt B, Irkec M. Topical Cyclosporine. A in the treatment of superior limbickera to conjunctivitis: a long-term follow-up. Cornea. 2008;27(2):193-5.

Schechter BA, Katz RS, Friedman LS. Efficacy oftopical Cyclosporine for the treatment of ocularrosacea. Adv Ther. 2009;26(6):651-9.

Wan KH, Chen LJ, Rong SS, Pang CP, Young AL. Topical Cyclosporine in the treatment of allergic conjunctivitis: a meta-analysis. Ophthalmology. 2013;120(11):2197-203.

Zicari AM, Zicari A, Nebbioso M, Mari E, Celani C, Lollobrigida V, et al. High‐mobility group box‐1 (HMGB‐1) and serum soluble receptor for advanced glycation end products (sRAGE) in children affected by vernal keratoconjunctivitis. Pediatric Allergy and Immunology. 2014 Feb;25(1):57-63.

Aoki S, Mizote H, Minamoto A, Suzuki M, Mishima HK, Tanaka H, Systemic FK506 improved tear secretionin dry eye associated with chronic graft versus hostdisease. Br J Ophthalmol. 2005;89:243-4.

Xie H, Chen J, Lin Y, Liu Y, Ye C, Zhou S. Effect of topical FK506 used alone or combined with keratoplasty on patients with recurrent Mooren's corneal ulcer. Yan ke xue bao Eye science. 2006 Dec;22(4):207-13.

Nivenius E, Van Der Ploeg I, Jung K, Chryssanthou E, van Hage M, Montan PG. Tacrolimus ointment vs steroid ointment for eyelid dermatitis in patients with atopic keratoconjunctivitis. Eye. 2007 Jul;21(7):968.

Moscovici BK, Holzchuh R, Chiacchio BB, Santo RM, Shimazaki J, Hida RY. Clinical treatment of dry eye using 0.03% tacrolimus eye drops. Cornea. 2012 Aug 1;31(8):945-9.

Sanz-Marco E, Udaondo P, García-Delpech S, Vazquez A, Diaz-Llopis M. Treatment of Refractory Dry Eye Associated with Graft Versus Host Disease with 0.03% Tacrolimus Eyedrops. Journal of Ocular Pharmacology and Therapeutics. 2013;29(8):776-83.

Moscovici BK, Holzchuh R, Sakassegawa-Naves FE, Hoshino-Ruiz DR, Albers MB, Santo RM, et al. Treatment of Sjögren's syndrome dry eye using 0.03% tacrolimus eye drop: Prospective double-blind randomized study. Contact Lens and Anterior Eye. 2015 Oct 1;38(5):373-8.

Stonecipher KG, Torkildsen GL, Ousler GW, Morris S, Villanueva L, Hollander DA. The IMPACT study: a prospective evaluation of the effects of Cyclosporine ophthalmic emulsion 0.05% on ocular surface staining and visual performance in patients with dry eye. Clinical Ophthalmology (Auckland, NZ). 2016;10:887-95.

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Published

2018-10-23

How to Cite

Fatima, Z., Chaurasia, R. C., & Singh, S. P. (2018). Comparative analysis of efficacy and adverse effects of tacrolimus vs cyclosporine in chronic dry eye disease: a tertiary care hospital based study. International Journal of Basic & Clinical Pharmacology, 7(11), 2216–2222. https://doi.org/10.18203/2319-2003.ijbcp20184330

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Original Research Articles