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Abstract
Purpose
To evaluate and compare the efficacy and safety of cyclosporine 0.05% (Cyporin N eye drops 0.05%) to an active com-parator (Restasis®) in moderate to severe dry eye patients.
Methods
This is a multicenter, randomized, double-blind, parallel, active control, non-inferiority, phase Ⅲ study. Patients had a 2-week run-in period (during the run-in period, patients used artificial tears, if applicable), and afterward 158 patients were randomly assigned treatment for 12 weeks with cyclosporine 0.05% (with artificial tears, if applicable), in which the efficacy and safety were evaluated every four weeks.
Results
Corneal staining tests showed that in the per protocol set group, the study group was not inferior to the control group; the results for the full analysis set analytic group were the same. The number of adverse events reported from the 158 patients was not significantly different between groups (p = 0.1107). Additionally, other evaluations, including tolerability evaluations, clinical pathology examinations, and vital signs, show that there is no difference in terms of safety between the groups.
References
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Figure 1
Mean value of corneal staining score for patients with dry eye disease who were treated with two groups of cyclosporine 0.05% eye drop for three months. Corneal staining scores (using Oxford scale from 0 to 5) were assessed. * p < 0.0001 compared with baseline.
Figure 2
Schirmer scores for patients with dry eye disease who were treated with two groups of cyclosporine 0.05% eye drop for three months. Schirmer scores (change from baseline, mm) were assessed with and without anesthesia. * p < 0.05 compared with baseline (without anesthesia).
Table 1.
Patient demographics and clinical information
| Parameters | Cyporin N eye drop 0.05% | Restasis® 0.05% | p-value |
|---|---|---|---|
| Patients (n) | 80 | 78 | |
| Age (years) | 53.20 ± 14.53 (20–79) | 53.19 ± 12.50 (21–75) | 0.99* |
| Age ≥50 (years, n [%]) | 57 (71.25) | 51 (68.36) | |
| Male sex (n, %) | 20 (25.0) | 20 (25.64) | |
| Height (cm) | 160.59 ± 8.38 | 161.03 ± 7.00 | 0.73* |
| (136.5–183.0) | (149.0–180.0) | ||
| Weight (kg) | 59.90 ± 9.88 | 59.82 ± 7.63 | 0.96* |
| (39.0–90.0) | (44.0–79.0) | ||
| Past medical history (n, %) | 25 (31.25) | 21 (26.92) | 0.55† |
| Past surgical history (n, %) | 9 (11.25) | 8 (10.26) | 0.84† |
Table 2.
Treatment-related adverse events
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