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We aimed to determine the therapeutic efficacy of 0.05% topical cyclosporine A (CsA) for chronic ocular surface disease (OSD) in patients using benzalkonium chloride (BAK)-preserved antiglaucoma eye drops. A prospective, randomized, paired-eye, controlled clinical trial was conducted with participants who had been instilling at least one BAK-preserved topical antiglaucoma drug in both eyes for at least 6 months. Topical CsA was only applied in randomly selected unilateral eyes. Visual field (VF) indices, ocular surface parameters, tear meniscus height (TMH), and matrix metalloproteinase-9 (MMP-9) immunoassay were evaluated at baseline and at 2 and 4 months. Seventy eyes from 35 participants were included in the study. The Schirmer I, tear breakup time, and TMH increased by 4.5 ± 8.6 mm ( < 0.01), 5.0 ± 5.3 s ( < 0.001), and 85.4 ± 159.0 μm ( < 0.01) in the treated eyes at 4 months from baseline, respectively. The ocular staining score and MMP-9 positivity in the treated eyes decreased by 2.2 ± 1.3 ( < 0.001) and 0.7 ± 0.9 points ( < 0.001), respectively, at 4 months. In untreated eyes, only TMH increased by 41.4 ± 92.1 μm ( = 0.016) from baseline to 4 months. In VF indices, the tracking failure frequency was 19.09% ± 21.62%, and the test duration was 336.0 ± 79.5 s in the treated eyes at 4 months, which were lower than 34.37% ± 23.13% ( < 0.001) and 375.9 ± 70.7 s ( < 0.05) in the nontreated eyes. Application of topical 0.05% CsA significantly improved the OSD parameters and the reliability indices of VF tests. This study was registered with the Clinical Research Information Service (CRIS) (number KCT0007124).
Department of Ophthalmology, Keimyung University School of Medicine, Dongsan Medical Center, Daegu, Republic of Korea.
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