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Rossen Hazarbassanov, Camila Yamasato, Danielle Miura, Jeison Barros, Jose Alvaro Pereira Gomes; Topical immunomodulator use in the treatment of primary or secondary Sjogren dry eye disease patients. Invest. Ophthalmol. Vis. Sci. 2014;55(13):3684.
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To determine the efficacy of an immunomodulating topical medication containing 0.05% ciclosporine A (CsA), compared to a castor-oil based topical lubricant, on the treatment of dry eye disease (DED) due to primary or secondary Sjogren’s syndrome.
Clinical randomized, double-blind, efficacy and safety study (NCT02004067). Thirty seven patients with previously diagnosed primary or secondary Sjogren’s syndrome (SS) according to a revised version of the European criteria proposed by the American-European Consensus Group were included in the study. Participants were randomized in two groups, the first was composed by 20 patients (100% female; mean age±SD: 55.00 ±7.42) who were treated with CsA 0.05% (Restasis®, Allergan Inc.), while the second included 17 patients (94,1% female; mean age±SD: 50.86 ±12.06) who were treated with castor-oil based topical lubricant (Refresh Endura®, Allergan, Inc.). Both eye drops were preservative free and applied 3 times a day for 3 months. All patients were submitted to the following tests, for DED diagnose and follow-up: Ocular Surface Disease Index (OSDI), patient symptomatology questionnaire, best spectacle corrected visual acuity (BSCVA), biomicroscopy, Schirmer 1 test without anesthesia, fluorescein break up time (FBUT), fluorescein and lissamine green staining and impression cytology (IC) of superior and temporal conjunctiva.
Both topical castor-oil lubricant and CsA treatments led to significant improvement in symptoms such as dryness, burning and foreign body sensation (Wilcoxon, p<0.05). However, CsA treatment improved OSDI, photophobia and blurred vision (Wilcoxon, p<0.05). Nonetheless, castor-oil treatment induced significant improvement in ocular pain and lissamine green conjunctival staining (Wilcoxon, p<0.05). IC in temporal conjunctiva did not show a significant improvement or worsening of total score after 3 months treatment with either for castor-oil or CsA (Wilcoxon, p>0.05).
Both topical CsA 0.05% and castor oil eye drops treatments are effective for the treatment of Sjogren’s DED, while IC findings show that the inflammatory process remains stable. Those findings suggest that immunomodulatory or castor-oil eye drops can be prescribed for primary or secondary Sjogren’s syndrome DED patients.
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