A Prospective, Multi Center Comparative Case-Control Study to investigate the Clinical Efficacy of Re-esterified TG form Omega-3 fatty acids in Dry Eye Patients with Meibomian gland dysfunction

Seoul National University Bundang Hospital0 个研究点目标入组 132 人开始时间: 待定最近更新: 2020年4月21日

试验速览

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•1) Patient who was diagnosed with dry eye syndrome with meibomian gland dysfunction and voluntarily agreed to participate in clinical trial.
•2) Dry eye syndrome with Meibomian gland dysfunction is diagnosed based on the following criteria.
•i. Dry eye symptoms persist for at least 3 months before enrollment
•ii. Tear film break-up time is less than 10 seconds and satisfying at least one of the following three criteria
•a. When the eyelids are compressed, the secretion of meibomian gland is reduced, resulting in muddy, toothpaste-like discharge or viscous discharge
•b. Presence of two or more telangiectasia at the lid margin
•c. Presence of two or more orifice pluging
•3) Ocular surface disease index (OSDI) score of at least 23 (moderate OSDI score)

•1) Sjogren's syndrome
•2) There is no secretion of meibum due to complete blockage of meibomian gland orifices in the upper and lower eyelids
•3) Those who used cyclosporine, steroids or antibiotics (eye drops) within 2 weeks of the screening test
•4) Those who use eye drops containing lipid components within 2 weeks of the screening test
•5) Wear contact lens within one month of the screening test
•6) Ophthalmic surgery and trauma within the last 3 months
•7) Those who are planning to undergo eye surgery (including LASIK / LASEK) during the study period.
•8) Pregnant, lactating and female patients with pregnancy plans
•9) Patients with hypersensitivity to the test drug
•10) Patients allergic to flurescein or topical anesthesia
•11) Patients who use systemic drug which may affect lipids (tetracycline derivatives, antihistamine, isotretinoin, vitamin A)
•12) Others judged by the examiner as inappropriate

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