KCT0007857
Completed
未知
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 sites90 target enrollmentTBD
ConditionsDiseases of the eye and adnexa
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the eye and adnexa
- Sponsor
- Yonsei University Health System, Gangnam Severance Hospital
- Enrollment
- 90
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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