Clinical Efficacy of Re-esterified TG form Omega-3 fatty acids

Not Applicable

• Conditions: Diseases of the eye and adnexa

• Registration Number: KCT0004927
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 April 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

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)

Exclusion Criteria

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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ocular Surface Disease Index (OSDI);Visual Function Questionnaire-25 (VFQ-25);Matrixmetalloproteinase-9 grade;Corena and conjunctival NEI scale using fluorescein sodium;Tear Break Up Time;Lid Wiper Epitheliopathy grade;Meibomian gland dysfunction grade

Secondary Outcome Measures

Name	Time	Method
Meibography grade;Lipid layer thickness;Compliance of omega-3 or control drug;Omega-3 index