Topical Cyclosporine A 0.05% for the Treatment of Dry Eye Disease

Naeima M.  Elzlitni; Samar A.  Bukhatwa; Sabah S.  Eldressi

doi:10.54172/mjsc.v36i1.8

Authors

Naeima M. Elzlitni Ophthalmology Department, Faculty of medicine, University of Benghazi, Bengahzi, Libya.
Samar A. Bukhatwa Ophthalmology Department, Faculty of medicine, University of Benghazi, Bengahzi, Libya.
Sabah S. Eldressi Ophthalmology Department, Faculty of medicine, University of Benghazi, Bengahzi, Libya.

DOI:

https://doi.org/10.54172/mjsc.v36i1.8

Keywords:

Cyclosporine A, Dry Eye Disease (DED), Anti-inflammatory

Abstract

Dry eye disease (DED) is a common clinical condition that challenges ophthalmologists. Topical Cyclosporine A is an anti-inflammatory therapy being approved by the Food and Drug Administration (FDA) for the therapy for DED. This study aimed to evaluate the efficacy and pa- tient tolerability of topical Cyclosporine A 0.05% for the treatment of DED. A total of 87 patients diagnosed with DED were included in this study. Dry eye symptoms (foreign body sensation, burn- ing, and pain) were scored. As a baseline measurement, the tear break-up time test (TBUT) and the Schirmer’s test were performed for all the patients. Cyclosporine A 0.05% was given topically twice daily to all the patients for four months. They were followed up every month for a period of four months. The clinical signs (Schirmer’s test, the TBUT), and the symptoms scores, were record- ed for each visit. The mean age of the patients was 57.25±9.70 years (Range 32 - 80 years); 25 males (28.7%) and 62 females (71.3%). Out of them, 23 (26.4%) cases had Sjögren’s syndrome, and 12 (13.7%) cases had previous LASIK (laser in-situ keratomileusis). The symptoms score of the cases improved from (4.95±1.73) pretreatment to (0.40±.70) four months after treatment (P <0.001). The Schirmer’s test results improved from (4.10 ±1.089) pretreatment to (10.80±2.40) four months post-treatment (P <0.0001), and the TBUT test results improved from (5.54±1.77 s) pre- treatment to (12.95±3.12 s) four months post-treatment (P <0.0001). Only seven patients (8%) de- veloped ocular side effects in the form of redness, pain, and systemic side effects in the form of headache. In conclusion, Cyclosporine A 0.05% eye drops is an effective treatment for DED, im- proving both signs and symptoms of DED with few ocular side effects.

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References

Al-Nashar, H. Y. (2015). Efficacy of topical cyclosporine 0.05% eye drops in the treatment of dry eyes. Journal of the Egyptian Ophthalmological Society, 108(4), 233. DOI: https://doi.org/10.4103/2090-0686.174683

Barbarino, J. M., Staatz, C. E., Venkataramanan, R., Klein, T. E., & Altman, R. B. (2013). PharmGKB summary: cyclosporine and tacrolimus pathways. Pharmacogenetics and genomics, 23(10), 563. DOI: https://doi.org/10.1097/FPC.0b013e328364db84

Baudouin, C., Figueiredo, F. C., Messmer, E. M., Ismail, D., Amrane, M., Garrigue, J.-S., Bonini, S., & Leonardi, A. (2017). A randomized study of the efficacy and safety of 0.1% cyclosporine A cationic emulsion in treatment of moderate to severe dry eye. European journal of ophthalmology, 27(5), 520-530. DOI: https://doi.org/10.5301/ejo.5000952

Behrens, A., Doyle, J. J., Stern, L., Chuck, R. S., McDonnell, P. J., Azar, D. T., Dua, H. S., Hom, M., Karpecki, P. M., & Laibson, P. R. (2006). Dysfunctional tear syndrome: a Delphi approach to treatment recommendations. Cornea, 25(8), 900-907. DOI: https://doi.org/10.1097/01.ico.0000214802.40313.fa

Brewitt, H., & Sistani, F. (2001). Dry eye disease: the scale of the problem. Survey of ophthalmology, 45, S199-S202. DOI: https://doi.org/10.1016/S0039-6257(00)00202-2

Byun, Y.-S., Rho, C. R., Cho, K., Choi, J. A., Na, K. S., & Joo, C.-K. (2011). Cyclosporine 0.05% ophthalmic emulsion for dry eye in Korea: a prospective, multicenter, open-label, surveillance study. Korean journal of ophthalmology: KJO, 25(6), 369. DOI: https://doi.org/10.3341/kjo.2011.25.6.369

Craig, J. P., Nichols, K. K., Akpek, E. K., Barbara Caffery, O., Dua, H. S., Joo, C.-K., Liu, Z., Nelson, J. D., Nichols, J. J., & Tsubota, K. (2017). TFOS DEWS II-Relazione su Definizione e Classificazione. Ocular Surface, 30, 276-283. DOI: https://doi.org/10.1016/j.jtos.2017.05.008

De Paiva, C. S., Pflugfelder, S. C., Ng, S. M., & Akpek, E. K. (2019). Topical cyclosporine A therapy for dry eye syndrome. Cochrane Database of Systematic Reviews(9). DOI: https://doi.org/10.1002/14651858.CD010051.pub2

Definition, D. (2007). The definition and classification of dry eye disease: report of the Definition and Classification Subcommittee of the International Dry Eye Workshop. Ocul Surf, 5, 75-92. DOI: https://doi.org/10.1016/S1542-0124(12)70081-2

Isreb, M., Greiner, J., Korb, D., Glonek, T., Mody, S., Finnemore, V., & Reddy, C. (2003). Correlation of lipid layer thickness measurements with fluorescein tear film break-up time and Schirmer's test. Eye, 17(1), 79-83. DOI: https://doi.org/10.1038/sj.eye.6700224

Javadi, M.-A., & Feizi, S. (2011). Dry eye syndrome. Journal of ophthalmic & vision research, 6(3), 192.

Kunert, K. S., Tisdale, A. S., Stern, M. E., Smith, J., & Gipson, I. K. (2000). Analysis of topical cyclosporine treatment of patients with dry eye syndrome: effect on conjunctival lymphocytes. Archives of ophthalmology, 118(11), 1489-1496. DOI: https://doi.org/10.1001/archopht.118.11.1489

Kymionis, G. D., Bouzoukis, D. I., Diakonis, V. F., & Siganos, C. (2008). Treatment of chronic dry eye: focus on cyclosporine. Clinical Ophthalmology (Auckland, NZ), 2(4), 829. DOI: https://doi.org/10.2147/OPTH.S1409

Lemp, M. A., Crews, L. A., Bron, A. J., Foulks, G. N., & Sullivan, B. D. (2012). Distribution of aqueous-deficient and evaporative dry eye in a clinic-based patient cohort: a retrospective study. Cornea, 31(5), 472-478. DOI: https://doi.org/10.1097/ICO.0b013e318225415a

Leonardi, A., Van Setten, G., Amrane, M., Ismail, D., Garrigue, J.-S., Figueiredo, F. C., & Baudouin, C. (2016). Efficacy and safety of 0.1% cyclosporine A cationic emulsion in the treatment of severe dry eye disease: a multicenter randomized trial. European journal of ophthalmology, 26(4), 287-296. DOI: https://doi.org/10.5301/ejo.5000779

Li, N., Deng, X.-G., & He, M.-F. (2012). Comparison of the Schirmer I test with and without topical anesthesia for diagnosing dry eye. International journal of ophthalmology, 5(4), 478.

Mah, F., Milner, M., Yiu, S., Donnenfeld, E., Conway, T. M., & Hollander, D. A. (2012). PERSIST: Physician’s Evaluation of Restasis® Satisfaction in Second Trial of topical cyclosporine ophthalmic emulsion 0.05% for dry eye: a retrospective review. Clinical Ophthalmology (Auckland, NZ), 6, 1971. DOI: https://doi.org/10.2147/OPTH.S30261

Matsuda, S., & Koyasu, S. (2000). Mechanisms of action of cyclosporine. Immunopharmacology, 47(2-3), 119-125. DOI: https://doi.org/10.1016/S0162-3109(00)00192-2

Othman, T. M., Mousa, A., Gikandi, P. W., AbdelMabod, M., & Abdelrahman, A. M. (2018). Efficacy and safety of using topical cyclosporine A for treatment of moderate to severe dry eye disease. Saudi Journal of Ophthalmology, 32(3), 217-221. DOI: https://doi.org/10.1016/j.sjopt.2018.06.001

Pei-Yu, L., Su-Ying, T., Ching-Yu, C., Jorn-Hon, L., Pesus, C., & Wen-Ming, H. (2003). Prevalence of dry eye among an elderly Chinese population in Taiwan. Ophthalmology, 110(6), 1096-1101. DOI: https://doi.org/10.1016/S0161-6420(03)00262-8

Pflugfelder, S. C., De Paiva, C. S., Villarreal, A. L., & Stern, M. E. (2008). Effects of sequential artificial tear and cyclosporine emulsion therapy on conjunctival goblet cell density and transforming growth factor-β2 production. Cornea, 27(1), 64-69. DOI: https://doi.org/10.1097/ICO.0b013e318158f6dc

Phogat, J., Verma, R., Rathi, M., Sachdeva, S., & Pandey, L. (2019). Efficacy of cyclosporine 0.05% in patients with dry eye syndrome. International Journal of Community Medicine and Public Health, 6(8), 3339. DOI: https://doi.org/10.18203/2394-6040.ijcmph20193451

Prabhasawat, P., Tesavibul, N., Karnchanachetanee, C., & Kasemson, S. (2013). Efficacy of cyclosporine 0.05% eye drops in Stevens Johnson syndrome with chronic dry eye. Journal of ocular pharmacology and therapeutics, 29(3), 372-377. DOI: https://doi.org/10.1089/jop.2012.0009

Schaumberg, D. A., Sullivan, D. A., Buring, J. E., & Dana, M. R. (2003). Prevalence of dry eye syndrome among US women. American journal of ophthalmology, 136(2), 318-326. DOI: https://doi.org/10.1016/S0002-9394(03)00218-6

Schein, O. D., MUÑO, B., Tielsch, J. M., Bandeen-Roche, K., & West, S. (1997). Prevalence of dry eye among the elderly. American journal of ophthalmology, 124(6), 723-728. DOI: https://doi.org/10.1016/S0002-9394(14)71688-5

Stern, M. E., Beuerman, R. W., Fox, R. I., Gao, J., Mircheff, A. K., & Pflugfelder, S. C. (1998). The pathology of dry eye: the interaction between the ocular surface and lacrimal glands. Cornea, 17(6), 584-589. DOI: https://doi.org/10.1097/00003226-199811000-00002

Strong, B., Farley, W., Stern, M. E., & Pflugfelder, S. C. (2005). Topical cyclosporine inhibits conjunctival epithelial apoptosis in experimental murine keratoconjunctivitis sicca. Cornea, 24(1), 80-85. DOI: https://doi.org/10.1097/01.ico.0000133994.22392.47

Sullivan, B. D., Crews, L. A., Sönmez, B., Maria, F., Comert, E., Charoenrook, V., de Araujo, A. L., Pepose, J. S., Berg, M. S., & Kosheleff, V. P. (2012). Clinical utility of objective tests for dry eye disease: variability over time and implications for clinical trials and disease management. Cornea, 31(9), 1000-1008. DOI: https://doi.org/10.1097/ICO.0b013e318242fd60

Tuan, H.-I., Chi, S.-C., & Kang, Y.-N. (2020). An updated systematic review with meta-analysis of randomized trials on topical cyclosporin A for dry-eye disease. Drug design, development and therapy, 14, 265. DOI: https://doi.org/10.2147/DDDT.S207743

Yavuz, B., Bozdağ Pehlivan, S., & Ünlü, N. (2012). An overview on dry eye treatment: approaches for cyclosporin a delivery. The Scientific World Journal, 2012. DOI: https://doi.org/10.1100/2012/194848