PURPOSE: To assess the effectiveness and tolerability of cyclosporine ophthalmic emulsion (CsA) 0.05% in patients with moderate to severe dry eye disease in Korea. METHODS: 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. RESULTS: 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%). CONCLUSIONS: Our findings indicate that CsA 0.05% is an effective and tolerable treatment for dry eye disease in Korean clinical practice.
Cyclosporine/*administration & dosage/adverse effects ; Dry Eye Syndromes/*drug therapy/epidemiology ; Emulsions ; Female ; Follow-Up Studies ; Humans ; Immunosuppressive Agents/*administration & dosage/adverse effects ; Male ; Middle Aged ; Population Surveillance ; Prospective Studies ; Republic of Korea/epidemiology ; Treatment Outcome

PURPOSE: To evaluate the clinical efficacy of newly developed guidelines for the diagnosis and management of dry eye. METHODS: This retrospective, multi-center, non-randomized, observational study included a total of 1,612 patients with dry eye disease who initially visited the clinics from March 2010 to August 2010. Korean guidelines for the diagnosis and management of dry eye were newly developed from concise, expert-consensus recommendations. Severity levels at initial and final visits were determined using the guidelines in patients with 90 +/- 7 days of follow-up visits (n = 526). Groups with different clinical outcomes were compared with respect to clinical parameters, treatment modalities, and guideline compliance. Main outcome measures were ocular and visual symptoms, ocular surface disease index, global assessment by patient and physician, tear film break-up time, Schirmer-1 test score, ocular surface staining score at initial and final visits, clinical outcome after three months of treatment, and guideline compliance. RESULTS: Severity level was reduced in 47.37% of patients treated as recommended by the guidelines. Younger age (odd ratio [OR], 0.984; p = 0.044), higher severity level at initial visit, compliance to treatment recommendation (OR, 1.832; p = 0.047), and use of topical cyclosporine (OR, 1.838; p = 0.011) were significantly associated with improved clinical outcomes. CONCLUSIONS: Korean guidelines for the diagnosis and management of dry eye can be used as a valid and effective tool for the treatment of dry eye disease.
Adult ; Aged ; Aged, 80 and over ; Diagnostic Techniques, Ophthalmological/*standards ; *Disease Management ; Dry Eye Syndromes/*diagnosis/*drug therapy/epidemiology ; Female ; Follow-Up Studies ; Humans ; Immunosuppressive Agents/*administration & dosage ; Male ; Middle Aged ; Morbidity/trends ; Ophthalmic Solutions ; *Practice Guidelines as Topic ; Republic of Korea/epidemiology ; Retrospective Studies ; Young Adult