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Rossen M Hazarbassanov, Jose Arthur Pinto Milhomens Filho, Nicolle Queiroz-Hazarbassanov, Jose Alvaro Pereira Gomes; Use of topical immunomodulator in the treatment of patients with aqueous deficient dry eye and evaporative dry eye. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):4031.
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© ARVO (1962-2015); The Authors (2016-present)
To determine efficacy of an immunomodulating topical medication containing 0.05% ciclosporine A(CsA), on the treatment of aqueous deficient dry eye(ADDE) and evaporative dry eye(EDE).
Clinical double-blind, efficacy and safety pilot study. Patients were submitted to the following tests during first visit (T0) and follow-up after one month (T1) and three months (T3): Ocular Surface Disease Index (OSDI), meibography and meniscus volume (Keratograph, Occulus), visual acuity (VA), biomicroscopy, Schirmer 1 test without anesthesia, fluorescein break up time (FBUT), staining with fluorescein and lissamine green 1%; plus impression cytology (IC) of superior and temporal conjunctiva followed by HE, which were analyzed for cellularity, cell-to-cell coesivity, nucleus to cytoplasm ratio, chromatin pattern, goblet cell distribution, keratinisation and inflammatory cells thus rendering a total cytological score, as well as HLA-DR immunostaining percentages.Eighteen patients were diagnosed for dry eye according to the following criteria: ADDE was defined as Foulks-Bron MGD score < 5 and Schirmer 1 test < 7mm in 5 minutes; EDE was determined as MGD score > 5 and Schirmer 1 > 7mm. Ten patients (100% female)(age mean ± SEM: 54.4 ± 7.7) presented ADDE and eight patients EDE (100% female)(age mean ± SEM: 64.25 ± 5.2). All received CsA 0.05% bid for 3 months.
Fluorescein staining was significantly higher for ADDE patients between T0 and T3 (Friedman-Dunn's, p=0.04). However, IC total score for temporal (Wilcoxon, p=0.02) and superior (Wilcoxon, p=0.04) region and HLA-DR staining in the superior region (Wilcoxon, p=0.02) decreased significantly for ADDE patients between T0 and T3. The tear meniscus volume increased significantly in the ADDE group at T1, when analyzed in the nasal (Friedman-Dunn's, p=0.04) and temporal (Friedman-Dunn's, p=0.03) regions.
Treatment of ADDE with CsA exhibited worsening in fluorescein staining, even though tear meniscus increases at T1, but possibly still insufficient at T3. For this same patient group, our findings suggest that CsA attenuates ocular surface inflammation as evidenced by decreasing IC total scores and HLA-DR expression. We did not observe any significant benefit or adverse effect for the EDE group during CsA treatment.
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