None listed
Conditions
Interventions
Drug : Instill one drop of Cyclosporine Ophthalmic Solution 0.05% into each eye twice daily at approximately 12-hour intervals for 8 weeks.
Sponsors
Gyeongsang National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients aged 19 years or older who have been diagnosed with dry eye disease, meeting all of the following criteria: ? Presence of corneal epithelial lesions due to dry eye disease (NEI score = 3) ? Tear break-up time (TBUT), measured by fluorescein staining, of less than 7 seconds ? Ocular Surface Disease Index (OSDI) score of 13 or higher Dry eye patients with clinically evident signs of ocular surface inflammation Individuals who have voluntarily agreed to participate in this study and have provided written informed consent
Exclusion criteria
Exclusion criteria: 1.Individuals who have used cyclosporin, diquafosol tetrasodium, rebamipide, or topical steroid eye drops within 4 weeks prior to screening 2.Individuals with severe ocular immune-related diseases or active ocular infections 3.Individuals diagnosed with Sjögren’s syndrome 4.Patients with severe blepharitis 5.Individuals with abnormal blinking patterns (e.g., Parkinson’s disease, facial nerve palsy) 6.Individuals with severe pterygium 7.Individuals who have undergone ocular surgery (including LASIK or LASEK) within 6 months prior to screening 8.Individuals who require the use of topical ophthalmic medications other than the investigational product (e.g., glaucoma eye drops, anti-allergic eye drops) 9.Individuals who have newly initiated systemic steroid medications or immunosuppressive agents, or had a change in dosage, within 4 weeks prior to screening 10.Individuals who require contact lens wear during the study period 11.Individuals with known hypersensitivity to the investigational product 12.Pregnant or breastfeeding women, or women planning to become pregnant during the study period 13.Individuals deemed inappropriate for participation in the study by the investigator 14.Individuals unable to read or understand the informed consent form, including illiterate individuals or foreign nationals unable to comprehend the document
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Analysis of changes in clinical signs and symptom scores at 8 weeks compared with baseline (NEI score, TBUT, Schirmer test I, bulbar conjunctival redness score, palpebral conjunctival redness score, MGD score, OSDI, NRS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the correlation between tear proteomic profiles and clinical findings in dry eye patients at baseline | — |
Countries
Korea, Republic of
Contacts
Public ContactHanbyul Yi
Gyeongsang National University Hospital
Outcome results
None listed