Korean J Ophthalmol.  2011 Dec;25(6):369-374. 10.3341/kjo.2011.25.6.369.

Cyclosporine 0.05% Ophthalmic Emulsion for Dry Eye in Korea: A Prospective, Multicenter, Open-Label, Surveillance Study

  • 1Department of Ophthalmology and Visual Science, Seoul St. Mary's Hospital, The Catholic University of Korea College of Medicine, Seoul, Korea. ckjoo@catholic.ac.kr
  • 2Department of Ophthalmology and Visual Science, St. Vincent Hospital, The Catholic University of Korea College of Medicine, Suwon, Korea.


To assess the effectiveness and tolerability of cyclosporine ophthalmic emulsion (CsA) 0.05% in patients with moderate to severe dry eye disease in Korea.
This was a prospective, multicenter, open-label, surveillance study of 392 Korean patients with moderate to severe dry eye disease who were treated with CsA 0.05% for three months. An assessment of effectiveness was performed at baseline, and after 1, 2, and 3 months. The primary effectiveness outcomes were changes in ocular symptoms and Schirmer score. The secondary effectiveness outcomes were a change in conjunctival staining, use of artificial tears, global evaluation of treatment, and patient satisfaction. The primary safety outcome was the incidence and nature of adverse events.
A total of 362 patients completed the study. After three months, all ocular symptom scores were significantly reduced compared to the baseline values, while the Schirmer scores were significantly increased relative to baseline (p < 0.0001). After three months, there were significant reductions from baseline in conjunctival staining (p < 0.01) and use of artificial tears (p < 0.0001). According to clinicians' global evaluations, most patients (>50%) experienced at least a 25% to 50% improvement in symptoms from baseline at each follow-up visit. The majority of patients (72.0%) were satisfied with the treatment results, and 57.2% reported having no or mild symptoms after treatment. The most common adverse events were ocular pain (11.0%).
Our findings indicate that CsA 0.05% is an effective and tolerable treatment for dry eye disease in Korean clinical practice.


Cyclosporine; Dry eye syndromes; Ophthalmic solutions

MeSH Terms

Cyclosporine/*administration & dosage/adverse effects
Dry Eye Syndromes/*drug therapy/epidemiology
Follow-Up Studies
Immunosuppressive Agents/*administration & dosage/adverse effects
Middle Aged
Population Surveillance
Prospective Studies
Republic of Korea/epidemiology
Treatment Outcome


  • Fig. 1 Schirmer scores for patients with dry eye disease who were treated with cyclosporine ophthalmic emulsion 0.05% for three months. Schirmer scores (change from baseline, mm) were assessed with and without anesthesia. Data are presented as mean ± standard deviation. *p < 0.0001 compared with baseline (both with and without anesthesia).

  • Fig. 2 Clinicians' global evaluations of improvement in patients with dry eye disease who were treated with cyclosporine ophthalmic emulsion 0.05% for three months. Data are presented as the percentage of patients with >90% improvement, 75% to 90% improvement, 25% to 50% improvement, condition unchanged, or condition worsened.

  • Fig. 3 Exit survey results for patients with dry eye disease who were treated with cyclosporine ophthalmic emulsion 0.05% (Restasis®) for three months. Data are presented as percentage of patients responding to the following questions: 'How are your chronic dry eye symptoms?' (A); 'With Restasis®, how does your chronic dry eye now affect your normal daily activities? (B); 'Overall, how satisfied are you with Restasis®?' (C); and 'How quickly did Restasis® start working to relieve your chronic dry eye symptoms?' (D).

Cited by  3 articles

Effects of Cyclosporine 0.05% Ophthalmic Emulsion to Improve Reduction of Tear Production after Cataract Surgery
Ae Ri Yoo, Hyung Bin Hwang, Hyun Kyung Kim, Sung Kun Chung
J Korean Ophthalmol Soc. 2013;54(7):1013-1018.    doi: 10.3341/jkos.2013.54.7.1013.

Effect of Cyclosporin A on Tear Film and Corneal Aberration after Cataract Surgery
Jei Hun Jeon, Hong Seok Kim, Ji Won Jung, Sang Chul Yoon, Kyoung Yul Seo, Hyung Keun Lee, Eung Kweon Kim, Tae Im Kim
J Korean Ophthalmol Soc. 2014;55(7):978-983.    doi: 10.3341/jkos.2014.55.7.978.

Comparisons for Evaluation of Efficacy and Safety of Cyclosporin A 0.05% Ophthalmic Emulsion Treatment Groups
Soonwon Yang, Yong-Soo Byun, Chang Rae Rho, Su Young Kim, Yang Kyung Cho, Eun Chul Kim, Sung Kun Chung, Choun-Ki Joo
J Korean Ophthalmol Soc. 2016;57(12):1849-1856.    doi: 10.3341/jkos.2016.57.12.1849.


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