J Korean Ophthalmol Soc.  2016 Dec;57(12):1849-1856. 10.3341/jkos.2016.57.12.1849.

Comparisons for Evaluation of Efficacy and Safety of Cyclosporin A 0.05% Ophthalmic Emulsion Treatment Groups

• Yang S
• Byun YS
• Rho CR
• Kim SY
• Cho YK
• Kim EC
• Chung SK
• Joo CK

• KMID: 2362701
• DOI: http://doi.org/10.3341/jkos.2016.57.12.1849

Abstract

PURPOSE
To evaluate and compare the efficacy and safety of cyclosporine 0.05% (Cyporin N eye drops 0.05%) to an active comparator (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.
CONCLUSIONS
Cyclosporine A 0.05% (Cyporin N eye drops 0.05%) is considered to have the same efficacy and safety compared to the active comparator.

Keyword

Cyclosporine; Dry eye syndromes; Ophthalmic solutions

MeSH Terms

Cyclosporine*
Dry Eye Syndromes
Humans
Lubricant Eye Drops
Ophthalmic Solutions
Pathology, Clinical
Vital Signs
Cyclosporine
Lubricant Eye Drops
Ophthalmic Solutions

Figure

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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).

Reference

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