Comparisons for Evaluation of Efficacy and Safety of Cyclosporin A 0.05% Ophthalmic Emulsion Treatment Groups.
10.3341/jkos.2016.57.12.1849
- Author:
Soonwon YANG
1
;
Yong Soo BYUN
;
Chang Rae RHO
;
Su Young KIM
;
Yang Kyung CHO
;
Eun Chul KIM
;
Sung Kun CHUNG
;
Choun Ki JOO
Author Information
1. Department of Ophthalmology and Visual Science, College of Medicine, The Catholic University of Korea, Seoul, Korea. ckjoo@catholic.ac.kr
- Publication Type:Multicenter Study ; Randomized Controlled Trial ; Original Article
- Keywords:
Cyclosporine;
Dry eye syndromes;
Ophthalmic solutions
- MeSH:
Cyclosporine*;
Dry Eye Syndromes;
Humans;
Lubricant Eye Drops;
Ophthalmic Solutions;
Pathology, Clinical;
Vital Signs
- From:Journal of the Korean Ophthalmological Society
2016;57(12):1849-1856
- CountryRepublic of Korea
- Language:Korean
-
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.
