A clinical trial to evaluate the efficacy and safety of Cyclosporine 0.1% (Ikervis®) for moderate to severe dry eye patients who changed to Cyclosporine 0.1% eye drop(Ikervis®) due to lack of treatment effects of the previous Cyclosporine 0.05% eye drop.
Eligible patients who agree to participate in the clinical trial in writing will be administered Cyclosporine 0.1% eye drop(Ikervis®) one drop once daily for 12 weeks. Efficacy and safety will be evaluated at baseline, 4 weeks, 8 weeks, and 12 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
90
One drop of Cyclosporine 0.1% (Ikervis®) eye drop once daily for 12 weeks
Severance Hospital
Seoul, South Korea
RECRUITINGCornea staining score (NEI scale)
The cornea staining score(NEI scale) is a grading scale for the corneal surface after fluorescein staining to help measure the efficacy of dry eye treatment. A standardized grading system of 0 to 3 is used for each of the five areas on each cornea. Grade 0 is specified when no staining is present, and the maximum score is 15.
Time frame: 12 weeks
Ratio of patients who have improvement, deterioration, and no-change of cornea staining scores(NEI scale)
Cornea staining scores (NEI scale) (Improvement: decrease by more than one point / Deterioration : increase by more than one point / No change: no change in score)
Time frame: 4 weeks, 8 weeks, 12 weeks
Conjunctival staining scores (NEI scale)
The conjunctival staining score(NEI scale) is a grading scale for the conjunctival surface after fluorescein staining to help measure the efficacy of dry eye treatment. A standardized grading system of 0 to 3 is used for each of the six areas on each conjunctiva. Grade 0 is specified when no staining is present, and the maximum score is 18.
Time frame: 4 weeks, 8 weeks, 12 weeks
Tear Break-Up Time (TBUT)
Tear Break-Up Time(TBUT) is a clinical test used to evaluate the dry eye disease after the fluorescein is instilled into the patient's tear film.
Time frame: 4 weeks, 8 weeks, 12 weeks
SANDE(Symptom Assessment in Dry Eye) score
SANDE (Symptom Assessment in Dry Eye)is a short questionnaire that quantifies both severity and frequency of dry eye symptoms
Time frame: 4 weeks, 8 weeks, 12 weeks
Tear Meniscometry score
A simple method of quantification of the volume of tear meniscus in the diagnosis of the dry eye syndromes.
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Time frame: 4 weeks, 8 weeks, 12 weeks
ODS (Ocular Discomfort Scale)
A simple questionnaire to evaluation the dry eye symptom of stinging, irritation, itching, and blurred vision.(0 to 10 points)
Time frame: 4 weeks, 8 weeks, 12 weeks
Patient Reported Outcome (PRO)
A short questionnaire to evaluation the improvement of dry eye symptom by a patient.
Time frame: 12 weeks