| Comparisons for Evaluation of Efficacy and Safety of Cyclosporin A 0.05% Ophthalmic Emulsion Treatment Groups. |
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Soonwon Yang, Yong Soo Byun, Chang Rae Rho, Su Young Kim, Yang Kyung Cho, Eun Chul Kim, Sung Kun Chung, Choun Ki Joo |
1Department of Ophthalmology and Visual Science, College of Medicine, The Catholic University of Korea, Seoul, Korea. ckjoo@catholic.ac.kr
2Department of Ophthalmology, The Catholic University of Korea Seoul St. Mary's Hospital, Seoul, Korea.
3Department of Ophthalmology, The Catholic University of Korea Daejeon St. Mary's Hospital, Daejeon, Korea.
4Department of Ophthalmology, The Catholic University of Korea Uijeongbu St. Mary's Hospital, Uijeongbu, Korea.
5Department of Ophthalmology, The Catholic University of Korea St. Vincent's Hospital, Suwon, Korea.
6Department of Ophthalmology, The Catholic University of Korea Bucheon St. Mary's Hospital, Bucheon, Korea.
7Department of Ophthalmology, The Catholic University of Korea St. Paul's Hospital, Seoul, Korea. |
| 사이클로스포린 A 0.05% 투여군 간 안전성 및 유효성을 비교평가하기 위한 제3상 임상시험 |
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양순원1,2⋅변용수1,2⋅노창래1,3⋅김수영1,4⋅조양경1,5⋅김은철1,6⋅정성근1,7⋅주천기1,2 |
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가톨릭대학교 의과대학 안과 및 시과학교실1, 가톨릭대학교 서울성모병원 안과학교실2, 가톨릭대학교 대전성모병원 안과학교실3, 가톨릭대학교 의정부성모병원 안과학교실4, 가톨릭대학교 성빈센트병원 안과학교실5, 가톨릭대학교 부천성모병원 안과학교실6, 가톨릭대학교 성바오로병원 안과학교실7 |
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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 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. |
| Key Words:
Cyclosporine;Dry eye syndromes;Ophthalmic solutions |
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