Purpose:: To compare the efficacy of topical cyclosporine 0.05% (tCsA) and combined treatment with 1% methylprednisolone acetate for the treatment of moderate-to-severe chronic dry eye. PATIENTS AND Methods:: Forty-four patients with moderate-to-severe dry eye who had not responded to conventional treatment were treated with tCsA for 3 months. Twenty-one subjects (Group 1) were treated with 1% methyl prednisolone acetate and tCsA for the initial 3 weeks, and treated with tCsA only thereafter, and 23 subjects (Group 2) were treated with tCsA only. Symptom scores, tear break-up time (TBUT), Schirmer score, and corneal and conjunctival fluorescein staining were evaluated before and at 1, 2, and 3 months after treatment. Proinflammatory factors, interleukin-6 (IL-6), and interleukin-8 (IL-8) tear concentration were measured before treatment and at 3 months. Results:: Symptom scores, Schirmer scores, TBUT score, corneal fluorescein, and conjunctival staining showed significant improvement at 1 month compared to baseline in group 1 (all P < 0.001), and all the same but few exceptions in group 2 (P=0.002 on Schirmer, P=0.267 on cornea stating). In symptom scores, Schirmer scores, and corneal staining, greater improvements were observed for group 1 at 1 month compared to group 2 (P < 0.001, P=0.039, P=0.01, respectively). However, in TBUT score and conjunctival staining, there were no between-group differences (P=0.277, P=0.254, respectively). The time interval from treatment initiation to symptom relief was shorter for group 1 than group 2. Both groups showed decreased tear IL-6 and IL-8 concentrations at 3 months compared to baseline levels (P < 0.05). However, no between-group differences were noted in mean concentrations of IL-6 and IL-8 at baseline and at 3 months. Conclusions:: Treatment with tCsA appears to be safe and effective in moderate-to-severe chronic dry eye. Additional short-term use of a topical steroid had the benefit of providing faster symptom relief and improvement of ocular sign without serious complications.
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