None listed
Conditions
Interventions
Drug : This clinical trial is a investigator initiated multi-center phase 4 clinical trial, and aims to confirm the efficacy and safety of Cyclosporine 0.1% (Ikervis 0.1%) and dry eye drops in dry eye
Sponsors
Koera University Guro Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adults between 19 and 80 years of age 2) Patients diagnosed with Meibomian Gland Dysfunction (MGD) who have had symptoms for more than 3 months from the date of consent, who have Meibomian gland obstruction, abnormal secretion, and/or lid margin inflammation 3) Patients who can prescribe Icurvis eye drops 0.1% for the indications in the currently approved product description 4) Those who have one or more of the symptoms of tear film instability (irritation, photophobia, tearing, dryness, foreign body sensation) 5) Those with less than 7 seconds of Tear Break Up Time (TBUT) 6) Those whose tear volume measured by Tear Meniscometry is less than 5mm/5 sec 7) Those with a score of 20 or higher in the SANDE (Symptom Assessment in Dry Eye) questionnaire on the severity and frequency of dry eye symptoms 8) Those who have consented in writing to this clinical trial
Exclusion criteria
Exclusion criteria: 1) Those who have used cyclosporine, steroid, or antibiotic eye drops within 4 weeks from the date of consent) 2) Those who wear contact lenses within 4 weeks from the date of consent or those who need to wear contact lenses during the clinical trial period 3) Those with Meibomian Gland Dysfunction (MGD) or other ocular inflammation other than dry eyes 4) Those who have had eye surgery (including LASIK/LASIK) or trauma within 3 months from the date of consent 5) Those who are planning eye surgery (including LASIK/LASIK) during the clinical trial period 6) Those who have taken a new immunosuppressant that can affect immune function within 4 weeks from the date of consent due to uncontrolled systemic disease, or have a change in the dose of a previously taken drug 7) Those who have taken tetracycline or doxycycline drugs within 4 weeks from the date of consent 8) Women who are pregnant, lactating, or planning to become pregnant 9) Those with hypersensitivity to the main ingredient or component of the clinical trial drug 10) Patients with or suspected of having an active eye infection or eye infection 11) Those who participated in other clinical trials within 3 months 12) Other clinical investigators who judged that it is inappropriate to participate in the clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Tear Break-up Time (TBUT) | — |
Secondary
| Measure | Time frame |
|---|---|
| Staining score (NEI): Cornea & Conjunctiva score change;Changes in the SANDE (Symptom Assessment in Dry Eye) score;Changes in Tear Meniscometry Test Values ??Between Test and Control Groups;Lipid layer thickness change; Changes in Meibograde score ;Changes in Meibum quality scores; MMP-9 change (change in Negative/Trace Positive/Weak Positive/Positive/Strong Positive ratio); Change in the number of incomplete blinking;Changes in Telangiectasia score | — |
Countries
Korea, Republic of
Contacts
Public Contactjongsuk Song
Koera University Guro Hospital
Outcome results
None listed