Clinical Trial on the Evaluation of Cyporin N Eye Drop for Dry Eye Patients with Meibomian Gland Dysfunctio
- Conditions
- Diseases of the eye and adnexa
- Registration Number
- KCT0004199
- Lead Sponsor
- Korea University Ansan Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 52
Subjects who visit Korea University Ansan Hospital during the study period and who diagnosed as dry eyes with meibomian gland dysfunction.
-Subjects who voluntarily agreed to participate in the study
-Subjects with symptoms of dry eyes with meibomian gland dysfunction at least 3 months
-Subjects who have tear break-up time less than 5 seconds
- Under 20 years of age
- History of using topical cyclosporine A, steroid, and antibiotic eye drops within 4 weeks of screening.
- Subjects who wear contact lenses within 4 weeks of screening.
- Subjects with ocular inflammation other than meibomian gland dysfunction and dry eyes
- History of ophthalmologic surgery and ocular trauma within torce within 3 months of screening
- Subjects who are planning to undergo eye surgery during the study period
- Pregnant, lactating women and women who have a pregnancy plan within 26 weeks of screening
- Those who have hypersensitivity to research medicines
- Those who have allergic reactions to fluorescein or topical anesthetic
- History of systemic use of tetracycline derivatives (antihistamine, isotretinoin)
- Those judged by researchers to be unsuitable
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ocular Surface Disease Index (OSDI) score
- Secondary Outcome Measures
Name Time Method Corneal staining score with fluorescein sodium, Tear break-up time, Anterior blepharitis grade, Meibomian Gland Dysfunction (MGD) grade, Schirmer test