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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0004927
Enrollment
132
Registered
2020-04-16
Start date
2020-05-01
Completion date
Unknown
Last updated
2020-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Hyaluronic acid and use them freely according to symptoms within 6 times a day.
Dietary Supplement : The experimental group and the control group are determined according to a randomly prepared table (the random number 1 or 2 generated using the Excel software program, 1 for the

Sponsors

Seoul National University Bundang Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Meibography grade;Lipid layer thickness;Compliance of omega-3 or control drug;Omega-3 index

Countries

Korea, Republic of

Contacts

Public ContactYoungsub Eom

Korea University Ansan Hospital

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 7, 2026