None listed
Conditions
Interventions
Drug : Test drug (Icurvis eye drop 0.1%)
Appearance (eye drops in a colorless and transparent plastic container with a white liquid)
Dose (cyclosporine 1 mg/mL)
Directions (Inject this drug 1 drop at
improvement of corneal epithelial disorders)
Directions (1 drop at a time, 6 times a day instillation. If this drug and other eye drops are administered in combination, administer at least 5 minutes a
Sponsors
Yonsei University Health System, Gangnam Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: *In the case of treatment group, those who satisfy the following conditions 1) Adults 19 years of age or older 2) Those with one or more dry eye symptoms (stiffness, foreign body sensation, irritation, bloodshot eyes, itching, blurred vision, pain, etc.) 3) Those who have been diagnosed as Level 2~4 according to the guidelines of the Korean Corneal Disease Study Group (KCDSG) with moderate or more dry eyes 4) TBUT 5 seconds or less, NEI 4 points (Cornea standard) or higher 5) Schirmer test result (without anesthetic) Those who are less than 10mm in 5 minutes 6) Those who voluntarily agreed to participate in this study * In the case of a normal control group, a person who satisfies the following conditions 1) Adults 19 years of age or older 2) Those who have dry eye symptoms but have not used treatment drugs 3) Those whose TBUT exceeds 5 seconds and NEI is less than 4 (Cornea standards) 4) Those with a SANDE score of 20 or higher
Exclusion criteria
Exclusion criteria: 1) Those who have used cyclosporine, diquafosol tetrasodium, or steroid eye drops within 4 weeks before screening 2) Those with severe eye inflammation/infection 3) Sjogren patients 4) Patients with severe blepharitis due to MGD (Meibomian gland dysfunction) 5) Those with abnormal blinking (eg Parkinson's disease or facial nerve palsy, etc.) 6) Those with severe pterygium 7) Those who have undergone eye surgery (including LASIK/LASIK) within 6 months prior to screening 8) Those who are using eye drops other than research drugs and drugs permitted for co-administration (glaucoma, allergies, etc.) *However, sodium hyaluronate 0.1% (1mg/ml) eye drops are allowed. 9) Those who have taken or are taking steroid drugs or immunosuppressants that may affect immune function within 4 weeks prior to screening 10) If it is necessary to wear contact lenses during the test period 11) Persons with hypersensitivity to research drugs 12) Pregnant women, lactating women and women planning to become pregnant 13) Other testers judged to be inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Qualitative and quantitative analysis result of protein through tear proteomic analysis at 8 weeks compared to baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Between-group comparison of Tear Break Up Time (TBUT) change at 8 weeks and 12 weeks from baseline; Comparison of changes in Tear Break Up Time (TBUT) ;Staining score (NEI) between the groups at 12 weeks compared to the baseline;Comparison of changes in staining score (NEI) measurements at each time point;5) Between-group comparison of changes in Symptom Assessment in Dry Eye (SANDE) score at 12 weeks from baseline; Comparison of changes in Symptom Assessment in Dry Eye (SANDE) score measurements at each time point; Between-Group Comparison of Patient Reported Outcome (PRO) at Week 12 | — |
Countries
Korea, Republic of
Contacts
Public ContactJin Hee Baek
Yonsei University Health System, Gangnam Severance Hospital
Outcome results
None listed