A multi-center study to evaluate the tear proteomics, efficacy and safety of 0.1% cyclosporine ophthalmic emulsion with 0.05% cyclosporine and 3% diquafosol ophthalmic solution for moderate to severe dry eye patients

Yonsei University Health System, Gangnam Severance Hospital0 个研究点目标入组 90 人开始时间: 待定最近更新: 2022年11月28日

适应症

试验速览

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•*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

•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

发起方

Yonsei University Health System, Gangnam Severance Hospital